Cancer Therapy Evaluation Program 3.0 CTCAE Version From 2.0 ...

Cancer Therapy Evaluation Program 

Common Terminology Criteria for Adverse Events - Mapping Document (Version 3.0 to 2.0) 

CTCAE Version From 3.0 

CTCAE Version To 2.0 

Category : ALLERGY/IMMUNOLOGY 

Adverse Event 

Allergic reaction/hypersensitivity (including drug fever) 

Allergic rhinitis (including sneezing, nasal stuffiness, 

postnasal drip) 

Autoimmune reaction 

Serum sickness 

Vasculitis 

Allergy/Immunology - Other (Specify, __) 

Category 

ALLERGY/IMMUNOLOGY 






Date : 07/15/2003 

- 1 of 101 - 

Adverse Event 

Allergic reaction/hypersensitivity (including drug fever) 

Allergic rhinitis (including sneezing, nasal stuffiness, postnasal 

drip) 

Autoimmune reaction 

Serum sickness 

Vasculitis 

Allergy-Other (Specify,_____) 

Public Health Service 

National Institutes of Health 

National Cancer Institute 

Bethesda, Maryland 20892 

Other Specify





Category : AUDITORY/EAR 

Adverse Event 

Hearing: patients with/without baseline audiogram and 

enrolled in a monitoring program 

Hearing: patients without baseline audiogram and not 

enrolled in a monitoring program 

Otitis, external ear (non-infectious) 

Otitis, middle ear (non-infectious) 

Tinnitus 

Auditory/Ear - Other (Specify, __) 

Category 

AUDITORY/HEARING 






Date : 07/15/2003 

- 2 of 101 - 

Adverse Event 

Auditory/Hearing-Other (Specify,_____) 

Inner ear/hearing 

External Auditory Canal 

Middle ear/hearing 







Other Specify 

Hearing: patients 

with/without baseline 

audiogram and enrolled in 

a monitoring program 

(10053491) 

Tinnitus (10043882)





Category : BLOOD/BONE MARROW 

Adverse Event 

Bone marrow cellularity 

CD4 count 

Haptoglobin 

Hemoglobin 

Hemolysis (e.g., immune hemolytic anemia, drug-related 

hemolysis) 

Iron overload 

Leukocytes (total WBC) 

Lymphopenia 

Myelodysplasia 

Neutrophils/granulocytes (ANC/AGC) 

Platelets 

Splenic function 

Blood/Bone Marrow - Other (Specify, __) 

Category 

BLOOD/BONE MARROW 













Date : 07/15/2003 

- 3 of 101 - 

Bone marrow cellularity 

CD4 count 

Haptoglobin 

Hemoglobin 

Adverse Event 

Hemolysis (e.g., immune hemolytic anemia, drug related 

hemolysis, other) 

Blood/Bone Marrow-Other (Specify,_____) 

Leukocytes (total WBC) 

Lymphopenia 


Neutrophils/granulocytes (ANC/AGC) 

Platelets 







Other Specify 

Iron overload (10005620) 

Myelodysplasia 

(10028532) 

Splenic function 

(10041634)





Category : CARDIAC ARRHYTHMIA 

Adverse Event 

Conduction abnormality/atrioventricular heart block 

Select 


Select 


Select 


Select 


Select 


Select 


Select 

Asystole 

AV Block-First degree 

AV Block-Second degree Mobitz Type I 

(Wenckebach) 

AV Block-Second degree Mobitz Type II 

AV Block-Third degree (Complete AV block) 

Conduction abnormality NOS 

Sick Sinus Syndrome 


Select Stokes-Adams Syndrome 

Category 

CARDIOVASCULAR 

(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 

Date : 07/15/2003 

- 4 of 101 - 

Adverse Event 

Cardiovascular/Arrhythmia-Other (Specify,_____) 





Conduction abnormality/Atrioventricular heart block 







Other Specify 

Conduction 

abnormality/atrioventricula 

r heart block: Asystole 

(10047284) 

Conduction 


r heart block: AV Block- 

First degree (10003674) 

Conduction 



Second degree Mobitz 

Type I (Wenckebach) 

(90030002) 

Conduction 



Second degree Mobitz 

Type II (90030004) 

Conduction 



Third degree (Complete 

AV block) (10003673) 

Conduction 


r heart block: Sick Sinus 

Syndrome (10040639) 

Conduction 


r heart block: Stokes- 

Adams Syndrome 

(10001115)






Adverse Event 


Select 

Palpitations 

Prolonged QTc interval 

Supraventricular and nodal arrhythmia 

Select 


Select 


Select 


Select 


Select 


Select 


Select 

Wolff-Parkinson-White Syndrome 

Atrial fibrillation 

Atrial flutter 

Atrial tachycardia/Paroxysmal Atrial Tachycardia 

Nodal/Junctional 

Sinus arrhythmia 

Sinus bradycardia 

Sinus tachycardia 


Select Supraventricular arrhythmia NOS 

Category 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 

Date : 07/15/2003 

- 5 of 101 - 

Adverse Event 


Palpitations 

Prolonged QTc interval (QTc > 0.48 seconds) 




Nodal/junctional arrhythmia/dysrhythmia 


Sinus bradycardia 

Sinus tachycardia 

Supraventricular arrhythmias (SVT/atrial fibrillation/flutter) 





Other Specify 

Conduction 


r heart block: Wolff- 

Parkinson-White 

Syndrome (10048015) 

Supraventricular and 

nodal arrhythmia: Atrial 

fibrillation (10003658) 



flutter (10003662) 



tachycardia/Paroxysmal 

Atrial Tachycardia 

(10003668) 


nodal arrhythmia: Sinus 

arrhythmia (10040739)






Adverse Event 


Select 


Select 

Vasovagal episode 

Ventricular arrhythmia 

Select 


Select 


Select 


Select 


Select 


Select 


Select 

Supraventricular extrasystoles (Premature Atrial 

Contractions; Premature Nodal/Junctional 

Contractions) 

Supraventricular tachycardia 

Bigeminy 

Idioventricular rhythm 

PVCs 

Torsade de pointes 

Trigeminy 

Ventricular arrhythmia NOS 

Ventricular fibrillation 


Select Ventricular flutter 

Category 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 


(ARRHYTHMIA) 

Date : 07/15/2003 

- 6 of 101 - 

Adverse Event 



Vasovagal episode 






Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular 

tachycardia) 







Other Specify 


nodal arrhythmia: 

Supraventricular 

extrasystoles (Premature 

Atrial Contractions; 

Premature 

Nodal/Junctional 

Contractions) (10042602) 


nodal arrhythmia: 

Supraventricular 

tachycardia (10042604) 

Ventricular arrhythmia: 

Bigeminy (10050779) 


Idioventricular rhythm 

(10039111) 


PVCs (10047289) 


Torsade de pointes 

(10044066) 


Trigeminy (10050780) 


Ventricular fibrillation 

(10047290) 


Ventricular flutter 

(10047294)






Adverse Event 


Select Ventricular tachycardia 

Cardiac Arrhythmia - Other (Specify, __) 

Category 


(ARRHYTHMIA) 


(ARRHYTHMIA) 

Date : 07/15/2003 

- 7 of 101 - 

Adverse Event 







Other Specify 


Ventricular tachycardia 

(10047302)





Category : CARDIAC GENERAL 

Adverse Event 

Cardiac ischemia/infarction 

Cardiac troponin I (cTnI) 

Cardiac troponin T (cTnT) 

Cardiopulmonary arrest, cause unknown (non-fatal) 

Hypertension 

Hypotension 

Left ventricular diastolic dysfunction 

Left ventricular systolic dysfunction 

Myocarditis 

Pericardial effusion (non-malignant) 

Pericarditis 

Pulmonary hypertension 

Restrictive cardiomyopathy 

Right ventricular dysfunction (cor pulmonale) 

Valvular heart disease 

Category 


(GENERAL) 


(GENERAL) 


(GENERAL) 


(GENERAL) 


(GENERAL) 


(GENERAL) 


(GENERAL) 


(GENERAL) 


(GENERAL) 


(GENERAL) 


(GENERAL) 


(GENERAL) 


(GENERAL) 


(GENERAL) 


(GENERAL) 

Date : 07/15/2003 

- 8 of 101 - 

Cardiac-ischemia/infarction 

Cardiac troponin I (cTnI) 

Cardiac troponin T (cTnT) 

Adverse Event 

Cardiovascular/General-Other (Specify,_____) 

Hypertension 

Hypotension 


Cardiac left ventricular function 

Myocarditis 

Pericardial effusion/pericarditis 










Other Specify 

Cardiopulmonary arrest, 

cause unknown (non-fatal) 

(10007617) 

Left ventricular diastolic 

dysfunction (10052337) 

Pericarditis (10034495) 

Pulmonary hypertension 

(10037403) 

Restrictive 

cardiomyopathy 

(10038748) 

Right ventricular 

dysfunction (cor 

pulmonale) (10010971) 

Valvular heart disease 

(10046972)





Category : CARDIAC GENERAL 

Adverse Event 

Cardiac General - Other (Specify, __) 

Category 


(GENERAL) 

Date : 07/15/2003 

- 9 of 101 - 

Adverse Event 






Other Specify





Category : COAGULATION 

Adverse Event 

DIC (disseminated intravascular coagulation) 

Fibrinogen 

INR (International Normalized Ratio of prothrombin time) 

PTT (Partial Thromboplastin Time) 

Thrombotic microangiopathy (e.g., thrombotic 

thrombocytopenic purpura [TTP] or hemolytic uremic 

syndrome [HUS]) 

Coagulation - Other (Specify, __) 

Category 

COAGULATION 

COAGULATION 

COAGULATION 

COAGULATION 

COAGULATION 

COAGULATION 

Date : 07/15/2003 

- 10 of 101 - 

Adverse Event 

DIC (disseminated intravascular coagulation) 

Fibrinogen 

Prothrombin time (PT) 

Partial thromboplastin time (PTT) 

Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic 

purpura/TTP or hemolytic uremic syndrome/HUS) 

Coagulation-Other (Specify,_____) 





Other Specify





Category : CONSTITUTIONAL SYMPTOMS 

Adverse Event 

Fatigue (asthenia, lethargy, malaise) 

Fever (in the absence of neutropenia, where neutropenia 

is defined as ANC





Category : DEATH 

Adverse Event 

Death not associated with CTCAE term 

Select 


Select 


Select 


Select 

Death NOS 

COMMENTS 

Category 

CONSTITUTIONAL 

SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 

Date : 07/15/2003 

- 12 of 101 - 

Adverse Event 

Constitutional Symptoms-Other (Specify,_____) 








Other Specify 

Death not associated with 

CTCAE term: Death NOS 

(10011914) 

Refer to CDUS Instructions & Guidelines regarding rules for reporting death. Death is to be reported either as a CTCAE v3.0 AE Grade 5 or as DEATH CATEGORY, Select. AdEERS 

and CDUS submissions will not accept both for the same patient. 

Disease progression NOS 

Multi-organ failure 

Sudden death 


CTCAE term: Disease 

progression NOS 

(10049830) 


CTCAE term: Multi-organ 

failure (10028154) 


CTCAE term: Sudden 

death (10042434)





Category : DERMATOLOGY/SKIN 

Adverse Event 

Atrophy, skin 

Atrophy, subcutaneous fat 

Bruising (in absence of Grade 3 or 4 thrombocytopenia) 

Burn 

Chelitis 

Dry skin 

Flushing 

Hair loss/alopecia (scalp or body) 

Hyperpigmentation 

Hypopigmentation 

Induration/fibrosis (skin and subcutaneous tissue) 

Injection site reaction/extravasation changes 

Nail changes 

Photosensitivity 

Pruritus/itching 

Rash/desquamation 

Rash: acne/acneiform 

Rash: dermatitis associated with radiation 

Select Chemoradiation 

COMMENTS 

Category 

DERMATOLOGY/SKIN 


















Date : 07/15/2003 

- 13 of 101 - 

Adverse Event 

Dermatology/Skin-Other (Specify,_____) 


Bruising (in absence of grade 3 or 4 thrombocytopenia) 



Dry skin 

Flushing 

Alopecia 


Pigmentation changes (e.g., vitiligo) 


Injection site reaction 

Nail changes 

Photosensitivity 

Pruritus 

Rash/desquamation 


Radiation recall reaction (reaction following chemotherapy in 

the absence of additional radiation therapy that occurs in a 

previous radiation port) 





Other Specify 

Atrophy, skin (10040799) 

Atrophy, subcutaneous fat 

(10016242) 

Burn (90030006) 

Chelitis (10008417) 

Hyperpigmentation 

(10040865) 

Induration/fibrosis (skin 

and subcutaneous tissue) 

(10050207) 

Rash: acne/acneiform 

(10000510) 

Radiation dermatitis is a specific skin manifestation and therefore v3.0 Rash: dermatitis associated with radiation - chemoradiation is an exception to the general approach of v3.0: 

"v3.0 Presents adverse events to standardize reporting across modalities. Therefore v3.0, wherever possible, has removed modality-based definitions for AEs."





Category : DERMATOLOGY/SKIN 

Adverse Event 

Rash: dermatitis associated with radiation 

Select Radiation 

COMMENTS 

Rash: erythema multiforme (e.g., Stevens-Johnson 

syndrome, toxic epidermal necrolysis) 

Rash: hand-foot skin reaction 

Skin breakdown/decubitus ulcer 

Striae 

Telangiectasia 

Ulceration 

Urticaria (hives, welts, wheals) 

Wound complication, non-infectious 

Dermatology/Skin - Other (Specify, __) 

Category 











Date : 07/15/2003 

- 14 of 101 - 

Radiation dermatitis 

Adverse Event 

Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic 

epidermal necrolysis) 

Hand-foot skin reaction 





Urticaria (hives, welts, wheals) 

Wound-non-infectious 






Other Specify 

Radiation dermatitis is a specific skin manifestation and therefore v3.0 Rash: dermatitis associated with radiation - radiation is an exception to the general approach of v3.0: "v3.0 

Presents adverse events to standardize reporting across modalities. Therefore v3.0, wherever possible, has removed modality-based definitions for AEs." 

Skin breakdown/decubitus 

ulcer (10011985) 

Striae (10040925) 

Telangiectasia 

(10043189) 

Ulceration (90030008)





Category : ENDOCRINE 

Adverse Event 

Adrenal insufficiency 

Cushingoid appearance (e.g., moon face, buffalo hump, 

centripetal obesity, cutaneous striae) 

Feminization of male 

Hot flashes/flushes 

Masculinization of female 

Neuroendocrine: 

ACTH deficiency 


ADH secretion abnormality (e.g., SIADH or low ADH) 


gonadotropin secretion abnormality 


growth hormone secretion abnormality 


prolactin hormone secretion abnormality 

Pancreatic endocrine: 

glucose intolerance 

Parathyroid function, low (hypoparathyroidism) 

Thyroid function, high (hyperthyroidism, thyrotoxicosis) 

Thyroid function, low (hypothyroidism) 

Endocrine - Other (Specify, __) 

Category 

ENDOCRINE 

ENDOCRINE 

ENDOCRINE 

ENDOCRINE 

ENDOCRINE 

ENDOCRINE 

ENDOCRINE 

ENDOCRINE 

ENDOCRINE 

ENDOCRINE 

ENDOCRINE 

ENDOCRINE 

ENDOCRINE 

ENDOCRINE 

ENDOCRINE 

Date : 07/15/2003 

- 15 of 101 - 

Adverse Event 

Endocrine-Other (Specify,_____) 

Cushingoid appearance (e.g., moon face, buffalo hump, 

centripetal obesity, cutaneous striae) 

Feminization of male 

Hot flashes/flushes 

Masculinization of female 


SIADH (syndrome of inappropriate antidiuretic hormone) 







Hypothyroidism 






Other Specify 

Adrenal insufficiency 

(10001369) 


ACTH deficiency 

(10005452) 


gonadotropin secretion 

abnormality (10054028) 


growth hormone secretion 

abnormality (10005572) 


prolactin hormone 

secretion abnormality 

(10005878) 

Pancreatic endocrine: 

glucose intolerance 

(10018429) 

Parathyroid function, low 

(hypoparathyroidism) 

(10021041) 

Thyroid function, high 

(hyperthyroidism, 

thyrotoxicosis) 

(10043789)





Category : GASTROINTESTINAL 

Adverse Event 

Anorexia 

Ascites (non-malignant) 

Colitis 

Constipation 

Dehydration 

Dental: 

dentures or prosthesis 

Dental: 

periodontal disease 

Dental: 

teeth 

Dental: 

teeth development 

Diarrhea 

Distension/bloating, abdominal 

Dry mouth/salivary gland (xerostomia) 

Dysphagia (difficulty swallowing) 

COMMENTS 

Enteritis (inflammation of the small bowel) 

Esophagitis 

Category 

GASTROINTESTINAL 















Date : 07/15/2003 

- 16 of 101 - 

Anorexia 

Ascites (non-malignant) 

Colitis 

Constipation 

Dehydration 

Adverse Event 

Gastrointestinal-Other (Specify,_____) 




Diarrhea patients without colostomy 


Mouth dryness 

Dysphagia-pharyngeal related to radiation 


Dysphagia, esophagitis, odynophagia (painful swallowing) 





Other Specify 

Dental: 

dentures or prosthesis 

(10050857) 

Dental: 

periodontal disease 

(10034537) 

Dental: 

teeth (10044035) 

Dental: 

teeth development 

(10044030) 

Distension/bloating, 

abdominal (10000060) 

v3.0 Dysphagia (difficulty swallowing) and v3.0 Esophagitis are a split of v2.0 Dysphagia, esophagitis, odynophagia (painful swallowing). In addition, v3.0 Dysphagia (difficulty 

swallowing) represents a merge of v2.0 Dysphagia-pharyngeal related to radiation and v2.0 Dysphagia-esophageal related to radiation. 

v3.0 Presents adverse events to standardize reporting across modalities. Therefore, v3.0 wherever possible, has removed modality-based definitions for AEs. 

COMMENTS 

Enteritis (inflammation of 

the small bowel) 

(10014866)






Adverse Event 

COMMENTS 

Category 

Date : 07/15/2003 

- 17 of 101 - 

Adverse Event 

v3.0 Esophagitis and v3.0 Dysphagia (difficulty swallowing) are a split of v2.0 Dysphagia, esophagitis, odynophagia (painful swallowing). 

Fistula, GI 

GASTROINTESTINAL Gastrointestinal-Other (Specify,_____) 

Select 

Fistula, GI 

Select 

v3.0 Fistula, GI-Anus is a split of v2.0 Fistula-rectal/anal. 

Fistula, GI 

Select 

Fistula, GI 

Select 

Fistula, GI 

Select 

Fistula, GI 

Select 

Fistula, GI 

Select 

Fistula, GI 

Select 

Fistula, GI 

Select 

Fistula, GI 

Select 

Fistula, GI 

Select 

Fistula, GI 

Select 

Abdomen NOS 

Anus 

COMMENTS 

Biliary tree 

Colon/cecum/appendix 

Duodenum 

Esophagus 

Gallbladder 

Ileum 

Jejunum 

Oral cavity 

Pancreas 

Pharynx 












Fistula-rectal/anal 




Fistula-esophageal 











Other Specify 

Fistula, GI: Abdomen 

NOS (90030010) 

Fistula, GI: Biliary tree 

(10004665) 

Fistula, GI: 


(10009995) 

Fistula, GI: Duodenum 

(10013828) 

Fistula, GI: Gallbladder 

(10017631) 

Fistula, GI: Ileum 

(90030012) 

Fistula, GI: Jejunum 

(90030014) 

Fistula, GI: Oral cavity 

(90030016) 

Fistula, GI: Pancreas 

(10049192) 

Fistula, GI: Pharynx 

(90030018)






Adverse Event 

Fistula, GI 

Select 

v3.0 Fistula, GI-Rectum is a split of v2.0 Fistula-rectal/anal. 

Fistula, GI 

Select 

Fistula, GI 

Select 

Fistula, GI 

Select 

Flatulence 

Gastritis (including bile reflux gastritis) 

Heartburn/dyspepsia 

Hemorrhoids 

Ileus, GI (functional obstruction of bowel, i.e., 

neuroconstipation) 

Incontinence, anal 

Leak (including anastomotic), GI 

Select 


Select 


Select 


Select 

Rectum 

COMMENTS 

Salivary gland 

Small bowel NOS 

Stomach 

Biliary tree 

Esophagus 

Large bowel 

Leak NOS 

Category 















Date : 07/15/2003 

- 18 of 101 - 

Adverse Event 



Fistula-intestinal 


Flatulence 

Gastritis 

Dyspepsia/heartburn 


Ileus (or neuroconstipation) 










Other Specify 

Fistula, GI: Rectum 

(10038062) 

Fistula, GI: Salivary gland 

(10039411) 

Fistula, GI: Stomach 

(90030020) 

Hemorrhoids (10019022) 

Incontinence, anal 

(10016092) 

Leak (including 

anastomotic), GI: Biliary 

tree (90030022) 


anastomotic), GI: 

Esophagus (90030024) 


anastomotic), GI: Large 

bowel (90030026) 


anastomotic), GI: Leak 

NOS (90030028)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 

Malabsorption 

Mucositis/stomatitis (clinical exam) 

Select 


Select 


Select 


Select 


Select 

Pancreas 

Pharynx 

Rectum 

Small bowel 

Stoma 

Stomach 

Anus 

Esophagus 

Large bowel 

Larynx 

Oral cavity 

COMMENTS 

Category 













Date : 07/15/2003 

- 19 of 101 - 

Adverse Event 












Mucositis due to radiation 

v3.0 Presents adverse events to standardize reporting across modalities. Therefore v3.0, wherever possible, has removed modality-based definitions for AEs. 





Other Specify 



Pancreas (10050457) 


anastomotic), GI: Pharynx 

(90030030) 


anastomotic), GI: Rectum 

(10054119) 


anastomotic), GI: Small 

bowel (90030032) 


anastomotic), GI: Stoma 

(90030034) 



Stomach (90030036) 

Malabsorption (10025476) 

Mucositis/stomatitis 

(clinical exam): Anus 

(90030038) 


(clinical exam): 



(clinical exam): Large 

bowel (90030042) 


(clinical exam): Larynx 

(90030044)






Adverse Event 


Select 


Select 


Select 


Select 


Select 

Mucositis/stomatitis (functional/symptomatic) 

Select 


Select 


Select 


Select 


Select 


Select 

Pharynx 

Rectum 

Small bowel 

Stomach 

Trachea 

Anus 

Esophagus 

Large bowel 

Larynx 

Oral cavity 

Pharynx 


Select Rectum 

Category 













Date : 07/15/2003 

- 20 of 101 - 

Adverse Event 










Stomatitis/pharyngitis (oral/pharyngeal mucositis) 







Other Specify 


(clinical exam): Pharynx 

(90030046) 


(clinical exam): Rectum 

(90030048) 


(clinical exam): Small 

bowel (90030050) 


(clinical exam): Stomach 

(90030052) 


(clinical exam): Trachea 

(90030054) 


(functional/symptomatic): 

Anus (90030056) 






Large bowel (90030060) 



Larynx (90030062) 



Pharynx (90030064) 



Rectum (90030066)






Adverse Event 


Select 


Select 


Select 

Nausea 

Necrosis, GI 

Select 

Necrosis, GI 

Select 

Necrosis, GI 

Select 

Necrosis, GI 

Select 

Necrosis, GI 

Select 

Necrosis, GI 

Select 

Necrosis, GI 

Select 

Necrosis, GI 

Select 

Necrosis, GI 

Select Oral 

Small bowel 

Stomach 

Trachea 

Anus 


Duodenum 

Esophagus 

Gallbladder 

Hepatic 

Ileum 

Jejunum 

Category 














Date : 07/15/2003 

- 21 of 101 - 

Adverse Event 




Nausea 














Other Specify 



Small bowel (90030068) 



Stomach (90030070) 



Trachea (90030072) 

Necrosis, GI: Anus 

(90030074) 

Necrosis, GI: 


(10014878) 

Necrosis, GI: Duodenum 

(90030076) 

Necrosis, GI: Esophagus 

(90030078) 

Necrosis, GI: Gallbladder 

(90030080) 

Necrosis, GI: Hepatic 

(10019692) 

Necrosis, GI: Ileum 

(90030082) 

Necrosis, GI: Jejunum 

(90030084) 

Necrosis, GI: Oral 

(10055670)






Adverse Event 

Necrosis, GI 

Select 

Necrosis, GI 

Select 

Necrosis, GI 

Select 

Necrosis, GI 

Select 

Necrosis, GI 

Select 

Necrosis, GI 

Select 

Necrosis, GI 

Select 

Obstruction, GI 

Select 


Select 


Select 


Select 


Select 


Select 

Pancreas 


Peritoneal cavity 

Pharynx 

Rectum 


Stoma 

Stomach 

Cecum 

Colon 

Duodenum 

Esophagus 

Gallbladder 

Ileum 

Select Jejunum 

Category 















Date : 07/15/2003 

- 22 of 101 - 

Adverse Event 



















Other Specify 

Necrosis, GI: Pancreas 

(10033654) 

Necrosis, GI: Peritoneal 

cavity (90030086) 

Necrosis, GI: Pharynx 

(90030088) 

Necrosis, GI: Rectum 

(90030090) 

Necrosis, GI: Small bowel 

NOS (90030092) 

Necrosis, GI: Stoma 

(90030094) 

Necrosis, GI: Stomach 

(10049150) 

Obstruction, GI: Cecum 

(90030096) 

Obstruction, GI: Colon 

(10010000) 

Obstruction, GI: 

Duodenum (10013830) 




Gallbladder (10017636) 

Obstruction, GI: Ileum 

(90030098) 

Obstruction, GI: Jejunum 

(90030100)






Adverse Event 


Select 


Select 


Select 


Select 

Perforation, GI 

Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Rectum 



Stoma 

Stomach 

Appendix 

Biliary tree 

Cecum 

Colon 

Duodenum 

Esophagus 

Gallbladder 

Ileum 

Jejunum 

Select Rectum 

Category 















Date : 07/15/2003 

- 23 of 101 - 

Adverse Event 



















Other Specify 

Obstruction, GI: Rectum 

(90030102) 

Obstruction, GI: Small 

bowel NOS (10041108) 

Obstruction, GI: Stoma 

(90030104) 

Obstruction, GI: Stomach 

(90030106) 

Perforation, GI: Appendix 

(90030108) 

Perforation, GI: Biliary tree 

(10034405) 

Perforation, GI: Cecum 

(10049873) 

Perforation, GI: Colon 

(10010001) 

Perforation, GI: 






Perforation, GI: Ileum 

(10021305) 

Perforation, GI: Jejunum 

(10023174) 

Perforation, GI: Rectum 

(10038073)






Adverse Event 


Select 


Select 

Proctitis 

Prolapse of stoma, GI 

Salivary gland changes/saliva 

Stricture/stenosis (including anastomotic), GI 

Select 


Select 


Select 


Select 


Select 


Select 


Select 


Stomach 

Anus 

Biliary tree 

Cecum 

Colon 

Duodenum 

Esophagus 

Ileum 


Select Jejunum 

Category 














Date : 07/15/2003 

- 24 of 101 - 

Adverse Event 



Proctitis 


Salivary gland changes 













Other Specify 

Perforation, GI: Small 

bowel NOS (10041104) 

Perforation, GI: Stomach 

(10017815) 

Prolapse of stoma, GI 

(90030110) 

Stricture/stenosis 

(including anastomotic), 

GI: Anus (10002176) 



GI: Biliary tree (10051341) 



GI: Cecum (10022700) 



GI: Colon (10010004) 



GI: Duodenum 

(10013834) 



GI: Esophagus 

(10030195) 



GI: Ileum (10021307) 



GI: Jejunum (10023176)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 

Taste alteration (dysgeusia) 

Typhlitis (cecal inflammation) 

Ulcer, GI 

Select 

Ulcer, GI 

Select 

Ulcer, GI 

Select 

Ulcer, GI 

Select 

Ulcer, GI 

Pancreas/pancreatic duct 

Pharynx 

Rectum 


Stoma 

Stomach 

Anus 

Cecum 

Colon 

Duodenum 

Select Esophagus 

Category 














Date : 07/15/2003 

- 25 of 101 - 

Adverse Event 







Taste disturbance (dysgeusia) 

Typhlitis (inflammation of cecum) 




Duodenal ulcer (requires radiographic or endoscopic 

documentation) 






Other Specify 



GI: Pancreas/pancreatic 

duct (90030112) 



GI: Pharynx (10050028) 



GI: Rectum (10038079) 



GI: Small bowel NOS 

(10041106) 



GI: Stoma (90030114) 



GI: Stomach (10017819) 

Ulcer, GI: Anus 

(10002180) 

Ulcer, GI: Cecum 

(90030116) 

Ulcer, GI: Colon 

(10023799) 

Ulcer, GI: Esophagus 

(10030201)






Adverse Event 

Ulcer, GI 

Select 

Ulcer, GI 

Select 

Ulcer, GI 

Select 

Ulcer, GI 

Select 

Ulcer, GI 

Select 

Ulcer, GI 

Vomiting 

Ileum 

Jejunum 

Rectum 


Stoma 

Select Stomach 

Gastrointestinal - Other (Specify, __) 

Category 









Date : 07/15/2003 

- 26 of 101 - 

Adverse Event 






Gastric ulcer (requires radiographic or endoscopic 

documentation) 

Vomiting 






Other Specify 

Ulcer, GI: Ileum 

(10021309) 

Ulcer, GI: Jejunum 

(10023177) 

Ulcer, GI: Rectum 

(10038080) 

Ulcer, GI: Small bowel 

NOS (10041109) 

Ulcer, GI: Stoma 

(90030118)





Category : GROWTH AND DEVELOPMENT 

Adverse Event 

Bone age (alteration in bone age) 

Bone growth: 

femoral head; slipped capital femoral epiphysis 

Bone growth: 

limb length discrepancy 

Bone growth: 

spine kyphosis/lordosis 

Growth velocity (reduction in growth velocity) 

Puberty (delayed) 

Puberty (precocious) 

Short stature 

Growth and Development - Other (Specify, __) 

Category 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 

Date : 07/15/2003 

- 27 of 101 - 

Adverse Event 














Other Specify 

Bone age (alteration in 

bone age) (10005954) 

Bone growth: 

femoral head; slipped 

capital femoral epiphysis 

(10041028) 

Bone growth: 

limb length discrepancy 

(90030120) 

Bone growth: 

spine kyphosis/lordosis 

(10023509) 

Growth velocity (reduction 

in growth velocity) 

(90030122) 

Puberty (delayed) 

(10012205) 

Puberty (precocious) 

(10036520) 

Short stature (10056811) 

Growth and Development 

- Other (Specify, __)





Category : HEMORRHAGE/BLEEDING 

Adverse Event 

Hematoma 

Hemorrhage/bleeding associated with surgery, intraoperative 

or postoperative 

Hemorrhage, CNS 

Hemorrhage, GI 

Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Abdomen NOS 

Anus 

Biliary tree 

Cecum/appendix 

Colon 

Duodenum 

Esophagus 

Ileum 

Jejunum 

Liver 


Select Lower GI NOS 

Category 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

Date : 07/15/2003 

- 28 of 101 - 

Adverse Event 

Hemorrhage-Other (Specify,_____) 

Hemorrhage/bleeding associated with surgery 

CNS hemorrhage/bleeding 











Melena/GI bleeding 





Other Specify 

Hematoma (10018854) 

Hemorrhage, GI: 

Abdomen NOS 

(10022729) 

Hemorrhage, GI: Anus 

(10049555) 

Hemorrhage, GI: Biliary 

tree (90030126) 


Cecum/appendix 

(90030128) 

Hemorrhage, GI: Colon 

(10009997) 





Hemorrhage, GI: Ileum 

(10021301) 

Hemorrhage, GI: Jejunum 

(10023173) 

Hemorrhage, GI: Liver 

(10019677)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Hemorrhage, GU 

Select 


Select 


Select 


Select 

Oral cavity 

Pancreas 


Rectum 

Stoma 

Stomach 

Upper GI NOS 

Varices (esophageal) 

Varices (rectal) 

Bladder 

Fallopian tube 

Kidney 

Ovary 


Select Prostate 

Category 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

Date : 07/15/2003 

- 29 of 101 - 

Adverse Event 




Rectal bleeding/hematochezia 


Hematemesis 




Hematuria (in the absence of vaginal bleeding) 









Other Specify 

Hemorrhage, GI: Oral 

cavity (10028024) 





(10034666) 

Hemorrhage, GI: Stoma 

(10049468) 

Hemorrhage, GI: Upper GI 

NOS (90030130) 

Hemorrhage, GI: Varices 

(esophageal) (10030209) 

Hemorrhage, GI: Varices 

(rectal) (10054787) 

Hemorrhage, GU: 

Fallopian tube (10050468) 

Hemorrhage, GU: Kidney 

(10038460) 

Hemorrhage, GU: Ovary 

(90030132) 


Prostate (10036960)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Hemorrhage, pulmonary/upper respiratory 

Select 

Retroperitoneum 

Spermatic cord 

Stoma 

Testes 

Ureter 

Urethra 

Urinary NOS 

Uterus 

Vagina 

Vas deferens 

Bronchopulmonary NOS 


Select Bronchus 

Category 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

Date : 07/15/2003 

- 30 of 101 - 

Adverse Event 









Vaginal bleeding 








Other Specify 


Retroperitoneum 

(10038980) 



(90030134) 

Hemorrhage, GU: Stoma 

(90030136) 

Hemorrhage, GU: Testes 

(10051877) 

Hemorrhage, GU: Ureter 

(90030138) 

Hemorrhage, GU: Urethra 

(10049710) 

Hemorrhage, GU: Urinary 

NOS (10050058) 

Hemorrhage, GU: Uterus 

(10046788) 

Hemorrhage, GU: Vas 

deferens (90030140) 

Hemorrhage, 

pulmonary/upper 

respiratory: 

Bronchopulmonary NOS 

(90030142) 

Hemorrhage, 


respiratory: Bronchus 

(90030144)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Larynx 

Lung 

Mediastinum 

Nose 

Pharynx 

Pleura 

Respiratory tract NOS 

Stoma 


Select Trachea 

Petechiae/purpura (hemorrhage/bleeding into skin or 

mucosa) 

Hemorrhage/Bleeding - Other (Specify, __) 

Category 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

HEMORRHAGE 

Date : 07/15/2003 

- 31 of 101 - 

Adverse Event 




Epistaxis 



Hemoptysis 



Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) 






Other Specify 

Hemorrhage, 


respiratory: Larynx 

(90030146) 

Hemorrhage, 


respiratory: Lung 

(10037394) 

Hemorrhage, 


respiratory: Mediastinum 

(10056343) 

Hemorrhage, 


respiratory: Pharynx 

(90030148) 

Hemorrhage, 


respiratory: Pleura 

(10035601) 

Hemorrhage, 


respiratory: Stoma 

(90030150) 

Hemorrhage, 


respiratory: Trachea 

(90030152)





Category : HEPATOBILIARY/PANCREAS 

Adverse Event 

Cholecystitis 

Liver dysfunction/failure (clinical) 

Pancreas, exocrine enzyme deficiency 

Pancreatitis 

Hepatobiliary/Pancreas - Other (Specify, __) 

HEPATIC 

HEPATIC 

HEPATIC 

Category 


HEPATIC 

Date : 07/15/2003 

- 32 of 101 - 

Hepatic-Other (Specify,_____) 

Adverse Event 

Liver dysfunction/failure (clinical) 


Pancreatitis 






Other Specify 

Cholecystitis (10008619) 

Pancreas, exocrine 

enzyme deficiency 

(10033622)





Category : INFECTION 

Adverse Event 

Colitis, infectious (e.g., Clostridium difficile) 

Febrile neutropenia (fever of unknown origin without 

clinically or microbiologically documented infection)(ANC 

=38.5 degrees C) 

Infection (documented clinically or microbiologically) with 

Grade 3 or 4 neutrophils (ANC






Adverse Event 








Adverse Event 








Adverse Event 








Adverse Event 








Adverse Event 








Adverse Event 








Adverse Event 








Adverse Event 








Adverse Event 








Adverse Event 








Adverse Event 








Adverse Event 








Adverse Event 








Adverse Event 

Infection with normal ANC or Grade 1 or 2 neutrophils 

Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select Colon 

Bone (osteomyelitis) 

Brain (encephalitis, infectious) 

Brain + Spinal cord (encephalomyelitis) 

Bronchus 

Catheter-related 

Cecum 

Cervix 

Category 

INFECTION/FEBRILE 

NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 

Date : 07/15/2003 

- 47 of 101 - 

Adverse Event 

Infection/Febrile Neutropenia-Other (Specify,____) 












Other Specify 

Infection with normal ANC 

or Grade 1 or 2 

neutrophils: Bone 

(osteomyelitis) 

(10005977) 



neutrophils: Brain 

(encephalitis, infectious) 

(10014601) 



neutrophils: Brain + Spinal 

cord (encephalomyelitis) 

(10058805) 



neutrophils: Bronchus 

(10006461) 



neutrophils: Catheterrelated 

(90030309) 



neutrophils: Cecum 

(90030310) 



neutrophils: Cervix 

(10008331) 



neutrophils: Colon 

(90030312)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Conjunctiva 

Cornea 

Dental-tooth 

Duodenum 

Esophagus 

External ear (otitis externa) 

Eye NOS 


Select Fallopian tube 

Category 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 



NEUTROPENIA 


NEUTROPENIA 

Date : 07/15/2003 

- 48 of 101 - 

Adverse Event 













Other Specify 



neutrophils: Conjunctiva 

(90030314) 



neutrophils: Cornea 

(10011020) 



neutrophils: Dental-tooth 

(10048762) 



neutrophils: Duodenum 

(90030316) 



neutrophils: Esophagus 

(90030318) 



neutrophils: External ear 

(otitis externa) (90030319) 



neutrophils: Eye NOS 

(10015936) 



neutrophils: Fallopian tube 

(90030320)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select Larynx 

Foreign body (e.g., graft, implant, prosthesis, stent) 

Gallbladder (cholecystitis) 

Heart (endocarditis) 

Ileum 

Jejunum 

Joint 

Kidney 

Category 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 

Date : 07/15/2003 

- 49 of 101 - 

Adverse Event 













Other Specify 



neutrophils: Foreign body 

(e.g., graft, implant, 

prosthesis, stent) 

(10059650) 



neutrophils: Gallbladder 

(cholecystitis) (90030322) 



neutrophils: Heart 

(endocarditis) (10014678) 



neutrophils: Ileum 

(90030324) 



neutrophils: Jejunum 

(90030326) 



neutrophils: Joint 

(10003259) 



neutrophils: Kidney 

(10023429) 



neutrophils: Larynx 

(90030328)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Lens 

Lip/perioral 

Liver 

Lung (pneumonia) 

Lymphatic 

Mediastinum NOS 

Meninges (meningitis) 

Middle ear (otitis media) 


Select Mucosa 

Category 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 

Date : 07/15/2003 

- 50 of 101 - 

Adverse Event 














Other Specify 



neutrophils: Lens 

(90030330) 



neutrophils: Lip/perioral 

(90030332) 



neutrophils: Liver 

(10056522) 



neutrophils: Lung 

(pneumonia) (10035725) 



neutrophils: Lymphatic 

(10050823) 



neutrophils: Mediastinum 

NOS (10057483) 



neutrophils: Meninges 

(meningitis) (10053638) 



neutrophils: Middle ear 

(otitis media) (10033084) 



neutrophils: Mucosa 

(10028810)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Muscle (infection myositis) 

Neck NOS 

Nerve-cranial 

Nerve-peripheral 

Nose 

Oral cavity-gums (gingivitis) 

Pancreas 


Select Paranasal 

Category 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 

Date : 07/15/2003 

- 51 of 101 - 

Adverse Event 













Other Specify 



neutrophils: Muscle 

(infection myositis) 

(10021918) 



neutrophils: Neck NOS 

(90030334) 



neutrophils: Nerve-cranial 

(90030336) 



neutrophils: Nerveperipheral 

(90030338) 



neutrophils: Nose 

(10059827) 



neutrophils: Oral cavitygums 

(gingivitis) 

(10058802) 



neutrophils: Pancreas 

(10051741) 



neutrophils: Paranasal 

(90030340)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Pelvis NOS 

Penis 

Peristomal 


Pharynx 

Pleura (empyema) 

Prostate 

Rectum 


Select Salivary gland 

Category 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 

Date : 07/15/2003 

- 52 of 101 - 

Adverse Event 














Other Specify 



neutrophils: Pelvis NOS 

(90030342) 



neutrophils: Penis 

(10034306) 



neutrophils: Peristomal 

(90030344) 



neutrophils: Peritoneal 

cavity (10057262) 



neutrophils: Pharynx 

(10034835) 



neutrophils: Pleura 

(empyema) (10051167) 



neutrophils: Prostate 

(10050662) 



neutrophils: Rectum 

(10002579) 



neutrophils: Salivary gland 

(90030346)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Scrotum 

Sinus 

Skin (cellulitis) 


Soft tissue NOS 

Spinal cord (myelitis) 

Spleen 

Stomach 



Category 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 

Date : 07/15/2003 

- 53 of 101 - 

Adverse Event 














Other Specify 



neutrophils: Scrotum 

(10039752) 



neutrophils: Sinus 

(10040756) 



neutrophils: Skin 

(cellulitis) (10040872) 



neutrophils: Small bowel 

NOS (90030348) 



neutrophils: Soft tissue 

NOS (10049582) 



neutrophils: Spinal cord 

(myelitis) (10049654) 



neutrophils: Spleen 

(10051724) 



neutrophils: Stomach 

(10056663) 



neutrophils: Trachea 

(10044303)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select Vein 

Ungual (nails) 

Upper aerodigestive NOS 

Upper airway NOS 

Ureter 

Urethra 

Urinary tract NOS 

Uterus 

Vagina 

Category 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 

Date : 07/15/2003 

- 54 of 101 - 

Adverse Event 














Other Specify 



neutrophils: Ungual (nails) 

(10028687) 



neutrophils: Upper 

aerodigestive NOS 

(90030350) 



neutrophils: Upper airway 

NOS (10049083) 



neutrophils: Ureter 

(10051250) 



neutrophils: Urethra 

(10052298) 



neutrophils: Urinary tract 

NOS (10046574) 



neutrophils: Uterus 

(10050447) 



neutrophils: Vagina 

(10046915) 



neutrophils: Vein 

(10056627)






Adverse Event 


Select 


Select 

Infection with unknown ANC 

Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Vulva 

Wound 

Abdomen NOS 

Anal/perianal 

Appendix 

Artery 

Biliary tree 

Bladder (urinary) 

Bone (osteomyelitis) 

Brain (encephalitis, infectious) 


Select Brain + Spinal cord (encephalomyelitis) 

Category 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 

Date : 07/15/2003 

- 55 of 101 - 

Adverse Event 
















Other Specify 



neutrophils: Vulva 

(10050348) 



neutrophils: Wound 

(90030351) 

Infection with unknown 

ANC: Abdomen NOS 

(90030352) 


ANC: Anal/perianal 

(90030354) 


ANC: Appendix 

(90030356) 


ANC: Artery (90030358) 


ANC: Biliary tree 

(90030360) 


ANC: Bladder (urinary) 

(90030362) 


ANC: Bone (osteomyelitis) 

(90030364) 


ANC: Brain (encephalitis, 

infectious) (90030366) 


ANC: Brain + Spinal cord 

(encephalomyelitis) 

(90030368)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Bronchus 

Catheter-related 

Cecum 

Cervix 

Colon 

Conjunctiva 

Cornea 

Dental-tooth 

Duodenum 

Esophagus 

External ear (otitis externa) 


Select Eye NOS 

Category 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 

Date : 07/15/2003 

- 56 of 101 - 

Adverse Event 


Catheter-related infection 















Other Specify 


ANC: Bronchus 

(90030370) 


ANC: Cecum (90030374) 


ANC: Cervix (90030376) 


ANC: Colon (90030378) 


ANC: Conjunctiva 

(90030380) 


ANC: Cornea (90030382) 


ANC: Dental-tooth 

(90030384) 


ANC: Duodenum 

(90030386) 


ANC: Esophagus 

(90030388) 


ANC: External ear (otitis 

externa) (10014012) 


ANC: Eye NOS 

(90030392)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select Liver 


Foreign body (e.g., graft, implant, prosthesis, stent) 

Gallbladder (cholecystitis) 

Heart (endocarditis) 

Ileum 

Jejunum 

Joint 

Kidney 

Larynx 

Lens 

Lip/perioral 

Category 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 

Date : 07/15/2003 

- 57 of 101 - 

Adverse Event 

















Other Specify 


ANC: Fallopian tube 

(90030394) 


ANC: Foreign body (e.g., 

graft, implant, prosthesis, 

stent) (90030396) 


ANC: Gallbladder 

(cholecystitis) (90030398) 


ANC: Heart (endocarditis) 

(90030400) 


ANC: Ileum (90030402) 


ANC: Jejunum 

(90030404) 


ANC: Joint (90030406) 


ANC: Kidney (90030408) 


ANC: Larynx (90030410) 


ANC: Lens (90030412) 


ANC: Lip/perioral 

(90030414) 


ANC: Liver (90030416)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Lung (pneumonia) 

Lymphatic 

Mediastinum NOS 

Meninges (meningitis) 

Middle ear (otitis media) 

Mucosa 

Muscle (infection myositis) 

Neck NOS 

Nerve-cranial 

Nerve-peripheral 

Nose 


Select Oral cavity-gums (gingivitis) 

Category 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 

Date : 07/15/2003 

- 58 of 101 - 

Adverse Event 

















Other Specify 


ANC: Lung (pneumonia) 

(90030418) 


ANC: Lymphatic 

(90030420) 


ANC: Mediastinum NOS 

(90030422) 


ANC: Meninges 

(meningitis) (90030424) 


ANC: Middle ear (otitis 

media) (90030426) 


ANC: Mucosa (90030428) 


ANC: Muscle (infection 

myositis) (90030430) 


ANC: Neck NOS 

(90030432) 


ANC: Nerve-cranial 

(90030434) 


ANC: Nerve-peripheral 

(90030436) 


ANC: Nose (90030438) 


ANC: Oral cavity-gums 

(gingivitis) (90030440)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Pancreas 

Paranasal 

Pelvis NOS 

Penis 

Peristomal 


Select Sinus 


Pharynx 

Pleura (empyema) 

Prostate 

Rectum 


Scrotum 

Category 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 

Date : 07/15/2003 

- 59 of 101 - 

Adverse Event 


















Other Specify 


ANC: Pancreas 

(90030442) 


ANC: Paranasal 

(90030444) 


ANC: Pelvis NOS 

(90030446) 


ANC: Penis (90030448) 


ANC: Peristomal 

(90030450) 


ANC: Peritoneal cavity 

(90030452) 


ANC: Pharynx (90030454) 


ANC: Pleura (empyema) 

(90030456) 


ANC: Prostate (90030458) 


ANC: Rectum (90030460) 


ANC: Salivary gland 

(90030462) 


ANC: Scrotum (90030464) 


ANC: Sinus (90030466)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Skin (cellulites) 



Spinal cord (myelitis) 

Spleen 

Stomach 

Trachea 

Ungual (nails) 



Ureter 


Select Urethra 

Category 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 

Date : 07/15/2003 

- 60 of 101 - 

Adverse Event 

















Other Specify 


ANC: Skin (cellulites) 

(90030468) 


ANC: Small bowel NOS 

(90030470) 


ANC: Soft tissue NOS 

(90030472) 


ANC: Spinal cord 

(myelitis) (90030474) 


ANC: Spleen (90030476) 


ANC: Stomach 

(90030478) 


ANC: Trachea (90030480) 


ANC: Ungual (nails) 

(90030482) 


ANC: Upper aerodigestive 

NOS (90030484) 


ANC: Upper airway NOS 

(90030486) 


ANC: Ureter (90030488) 


ANC: Urethra (90030490)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select Wound 

Opportunistic infection associated with >=Grade 2 

Lymphopenia 

Viral hepatitis 


Uterus 

Vagina 

Vein 

Vulva 

Infection - Other (Specify, __) 

Category 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 



NEUTROPENIA 


NEUTROPENIA 


NEUTROPENIA 

Date : 07/15/2003 

- 61 of 101 - 

Adverse Event 






Wound-infectious 








Other Specify 


ANC: Urinary tract NOS 

(90030492) 


ANC: Uterus (90030494) 


ANC: Vagina (90030496) 


ANC: Vein (90030498) 


ANC: Vulva (90030500) 

Opportunistic infection 

associated with >=Grade 

2 Lymphopenia 

(10030901) 

Viral hepatitis (10056885)





Category : LYMPHATICS 

Adverse Event 

Chyle or lymph leakage 

Dermal change lymphedema, phlebolymphedema 

Edema: 

head and neck 

Edema: 

limb 

Edema: 

trunk/genital 

Edema: 

viscera 

Lymphedema-related fibrosis 

Lymphocele 

Phlebolymphatic cording 

Lymphatics - Other (Specify, __) 

Category 

LYMPHATICS 

LYMPHATICS 

LYMPHATICS 

LYMPHATICS 

LYMPHATICS 

LYMPHATICS 

LYMPHATICS 

LYMPHATICS 

LYMPHATICS 

LYMPHATICS 

Date : 07/15/2003 

- 62 of 101 - 

Lymphatics-Other (Specify,___) 










Adverse Event 





Other Specify 

Chyle or lymph leakage 

(90030504) 

Dermal change 

lymphedema, 

phlebolymphedema 

(10025284) 

Edema: 

head and neck 

(90030506) 

Edema: 

limb (90030508) 

Edema: 

trunk/genital (90030510) 

Edema: 

viscera (90030512) 

Lymphedema-related 

fibrosis (90030514) 

Lymphocele (10048642) 

Phlebolymphatic cording 

(90030516)





Category : METABOLIC/LABORATORY 

Adverse Event 

Acidosis (metabolic or respiratory) 

Albumin, serum-low (hypoalbuminemia) 

Alkaline phosphatase 

Alkalosis (metabolic or respiratory) 

ALT, SGPT (serum glutamic pyruvic transaminase) 

Amylase 

AST, SGOT(serum glutamic oxaloacetic transaminase) 

Bicarbonate, serum-low 

Bilirubin (hyperbilirubinemia) 

Calcium, serum-low (hypocalcemia) 

COMMENTS 

Calcium, serum-high (hypercalcemia) 

Cholesterol, serum-high (hypercholestremia) 

CPK (creatine phosphokinase) 

Creatinine 

GGT (gamma-Glutamyl transpeptidase) 

Glomerular filtration rate 

Category 

METABOLIC/LABORATO 

RY 

HEPATIC 

HEPATIC 


RY 

HEPATIC 


RY 

HEPATIC 


RY 

HEPATIC 


RY 


RY 


RY 


RY 

RENAL/GENITOURINARY 

HEPATIC 


RY 

Date : 07/15/2003 

- 63 of 101 - 

Adverse Event 

Acidosis (metabolic or respiratory) 

Hypoalbuminemia 

Alkaline phosphatase 

Alkalosis (metabolic or respiratory) 

SGPT (ALT) (serum glutamic pyruvic transaminase) 

Amylase 

SGOT (AST) (serum glutamic oxaloacetic transaminase) 

Bicarbonate 

Bilirubin 

Hypocalcemia 

Hypercalcemia 

Hypercholesterolemia 

CPK (creatine phosphokinase) 

Creatinine 

GGT (Gamma-Glutamyl transpeptidase) 

Metabolic/Laboratory-Other (Specify,_____) 





Other Specify 

Calcium and Ionized calcium measurements are used interchangeably and both techniques appear together. While the measurement techniques differ, both measure abnormal serum 

calcium. 

COMMENTS 

Calcium and ionized calcium measurements are used interchangeably and both techniques appear together. While the measurement techniques differ, both measure abnormal serum 

calcium. 

Glomerular filtration rate 

(10018355)





Category : METABOLIC/LABORATORY 

Adverse Event 

COMMENTS 

Category 

Creatinine clearance is not included in v3.0. Alternatives include v3.0 Glomerular filtration rate and/or v3.0 Creatinine. 

Glucose, serum-high (hyperglycemia) 


RY 

Hyperglycemia 

Glucose, serum-low (hypoglycemia) 

Hemoglobinuria 

Lipase 

Magnesium, serum-high (hypermagnesemia) 

Magnesium, serum-low (hypomagnesemia) 

Phosphate, serum-low (hypophosphatemia) 

Potassium, serum-high (hyperkalemia) 

Potassium, serum-low (hypokalemia) 

Proteinuria 

Sodium, serum-high (hypernatremia) 

Sodium, serum-low (hyponatremia) 

Triglyceride, serum-high (hypertriglyceridemia) 

Uric acid, serum-high (hyperuricemia) 

Metabolic/Laboratory - Other (Specify, __) 


RY 



RY 


RY 


RY 


RY 


RY 


RY 



RY 


RY 


RY 


RY 


RY 

Date : 07/15/2003 

- 64 of 101 - 

Hypoglycemia 

Hemoglobinuria 

Lipase 

Hypermagnesemia 

Hypomagnesemia 

Hypophosphatemia 

Hyperkalemia 

Hypokalemia 

Proteinuria 

Hypernatremia 

Hyponatremia 

Hypertriglyceridemia 

Hyperuricemia 

Adverse Event 

Metabolic/Laboratory-Other (Specify,_____) 





Other Specify





Category : MUSCULOSKELETAL/SOFT TISSUE 

Adverse Event 

Arthritis (non-septic) 

Bone: spine-scoliosis 

Cervical spine-range of motion 

Exostosis 

Extremity-lower (gait/walking) 

Extremity-upper (function) 

Fibrosis-cosmesis 

Fibrosis-deep connective tissue 

Fracture 

Joint-effusion 

Joint-function 

Local complication -device/prosthesis-related 

Lumbar spine-range of motion 

Muscle weakness, generalized or specific area (not due to 

neuropathy) 

Select Extraocular 


neuropathy) 

Select Extremity-lower 

Category 

MUSCULOSKELETAL 















Date : 07/15/2003 

- 65 of 101 - 

Arthritis 

Adverse Event 

Musculoskeletal-Other (Specify,______) 


















Other Specify 

Bone: spine-scoliosis 

(10039722) 

Cervical spine-range of 

motion (90030518) 

Exostosis (10015688) 

Extremity-lower 

(gait/walking) (10017574) 

Extremity-upper (function) 

(90030520) 

Fibrosis-cosmesis 

(90030522) 

Fibrosis-deep connective 

tissue (90030524) 

Fracture (10017089) 

Joint-effusion (10023215) 

Joint-function (10023212) 

Local complication - 

device/prosthesis-related 

(90030526) 

Lumbar spine-range of 

motion (90030528) 

Muscle weakness, 

generalized or specific 

area (not due to 

neuropathy): Extraocular 

(10053635) 




neuropathy): Extremitylower 

(90030530)






Adverse Event 


neuropathy) 

Select Extremity-upper 


neuropathy) 

Select Facial 


neuropathy) 

Select Left-sided 


neuropathy) 

Select Ocular 


neuropathy) 

Select Pelvic 


neuropathy) 

Select Right-sided 


neuropathy) 

Select Trunk 

Category 








Date : 07/15/2003 

- 66 of 101 - 

Adverse Event 












Other Specify 




neuropathy): Extremityupper 

(90030532) 




neuropathy): Facial 

(90030534) 




neuropathy): Left-sided 

(90030536) 




neuropathy): Ocular 

(90030538) 




neuropathy): Pelvic 

(90030540) 




neuropathy): Right-sided 

(90030542) 




neuropathy): Trunk 

(90030544)






Adverse Event 


neuropathy) 

Select Whole body/generalized 

Muscular/skeletal hypoplasia 

Myositis (inflammation/damage of muscle) 

Osteonecrosis (avascular necrosis) 

Osteoporosis 

Seroma 

Soft tissue necrosis 

Select 


Select 


Select 


Select 


Select 


Select 

Abdomen 


Extremity-upper 

Head 

Neck 

Pelvic 


Select Thorax 

Trismus (difficulty, restriction or pain when opening mouth) 

Musculoskeletal/Soft Tissue - Other (Specify, __) 

Category 
















Date : 07/15/2003 

- 67 of 101 - 

Adverse Event 

Muscle weakness (not due to neuropathy) 


Myositis (inflammation/damage of muscle) 

Osteonecrosis (avascular necrosis) 
















Other Specify 

Muscular/skeletal 

hypoplasia (90030546) 

Osteoporosis (10031284) 

Seroma (10040102) 

Soft tissue necrosis: 

Abdomen (90030548) 



(90030550) 



(90030552) 

Soft tissue necrosis: Head 

(90030554) 

Soft tissue necrosis: Neck 

(90030556) 


Pelvic (90030558) 


Thorax (10043881) 

Trismus (difficulty, 

restriction or pain when 

opening mouth) 

(10044684)





Category : NEUROLOGY 

Adverse Event 

Apnea 

Arachnoiditis/meningismus/radiculitis 

Ataxia (incoordination) 

Brachial plexopathy 

CNS cerebrovascular ischemia 

CNS necrosis/cystic progression 

Cognitive disturbance 

Confusion 

Dizziness 

COMMENTS 

Category 

v3.0 Dizziness is a merge of v2.0 Dizziness/lightheadedness and v2.0 Vertigo. 

Encephalopathy 

NEUROLOGY 

Extrapyramidal/involuntary movement/restlessness 

Hydrocephalus 

Irritability (children






Adverse Event 

COMMENTS 

Category 

v3.0 Mood alteration-agitation is a split of v2.0 Mood alteration-anxiety, agitation. 

Mood alteration 

NEUROLOGY 

Select 

v3.0 Mood alteration-anxiety is a split of v2.0 Mood alteration-anxiety, agitation. 


NEUROLOGY 

Select 


Select 

Myelitis 

Neuropathy: cranial 

Select 


Select 


Select 


Select 


Select 


Select 


Select 

Anxiety 

COMMENTS 

Depression 

Euphoria 

CN I Smell 

CN II Vision 

CN III Pupil, upper eyelid, extra ocular movements 

CN IV Downward, inward movement of eye 

CN IX Motor-pharynx; Sensory-ear, pharynx, 

tongue 

CN V Motor-jaw muscles; Sensory-facial 

CN VI Lateral deviation of eye 

NEUROLOGY 

NEUROLOGY 


NEUROLOGY 

NEUROLOGY 

NEUROLOGY 

NEUROLOGY 

NEUROLOGY 

NEUROLOGY 

Date : 07/15/2003 

- 69 of 101 - 

Adverse Event 

Mood alteration-anxiety, agitation 

Mood alteration-depression 

Mood alteration-euphoria 

Neurology-Other (Specify,______) 

Sense of smell 











Other Specify 

Myelitis (10018526) 

Neuropathy: cranial: CN II 

Vision (10030932) 

Neuropathy: cranial: CN III 

Pupil, upper eyelid, extra 

ocular movements 

(10030073) 

Neuropathy: cranial: CN 

IV Downward, inward 

movement of eye 

(10044691) 


IX Motor-pharynx; 

Sensory-ear, pharynx, 

tongue (10018389) 

Neuropathy: cranial: CN V 

Motor-jaw muscles; 

Sensory-facial (10044647) 


VI Lateral deviation of eye 

(10053646)






Adverse Event 


Select 


Select 


Select 


Select 


Select 

Neuropathy: motor 

Neuropathy: sensory 

Personality/behavioral 

Phrenic nerve dysfunction 

Psychosis (hallucinations/delusions) 

COMMENTS 

Seizure 

CN VII Motor-face; Sensory-taste 

CN VIII Hearing and balance 

CN X Motor-palate; pharynx, larynx 

CN XI Motor-sternomastoid and trapezius 

CN XII Motor-tongue 

Somnolence/depressed level of consciousness 

Speech impairment (e.g., dysphasia or aphasia) 

Syncope (fainting) 

Category 

NEUROLOGY 

NEUROLOGY 

NEUROLOGY 

NEUROLOGY 

NEUROLOGY 

NEUROLOGY 

NEUROLOGY 

NEUROLOGY 

NEUROLOGY 

NEUROLOGY 

NEUROLOGY 

NEUROLOGY 

NEUROLOGY 

NEUROLOGY 

Date : 07/15/2003 

- 70 of 101 - 

Adverse Event 






Neuropathy - motor 

Neuropathy-sensory 

Personality/behavioral 



v3.0 Psychosis (hallucinations/delusions) is a merge of v2.0 Delusions and v2.0 Hallucinations. 

Pyramidal tract dysfunction (e.g., increased tone, 

NEUROLOGY 

Pyramidal tract dysfunction (e.g., increased tone, hyperreflexia, 

hyperreflexia, positive Babinski, decreased fine motor 

coordination) 

positive Babinski, decreased fine motor coordination) 

Seizure(s) 

Depressed level of consciousness 

Speech impairment (e.g., dysphasia or aphasia) 

Syncope (fainting) 





Other Specify 


VII Motor-face; Sensorytaste 

(10016051) 


VIII Hearing and balance 

(90030564) 

Neuropathy: cranial: CN X 

Motor-palate; pharynx, 

larynx (10046966) 


XI Motor-sternomastoid 

and trapezius (10000365) 


XII Motor-tongue 

(10020991) 

Phrenic nerve dysfunction 

(10012725) 

Psychosis 

(hallucinations/delusions) 

(10048343)






Adverse Event 

Tremor 

Neurology - Other (Specify, __) 

Category 

NEUROLOGY 

NEUROLOGY 

Date : 07/15/2003 

- 71 of 101 - 

Tremor 

Adverse Event 






Other Specify





Category : OCULAR/VISUAL 

Adverse Event 

Cataract 

Dry eye syndrome 

Eyelid dysfunction 

Glaucoma 

Keratitis (corneal inflammation/corneal ulceration) 

Night blindness (nyctalopia) 

Nystagmus 

Ocular surface disease 

Ophthalmoplegia/diplopia (double vision) 

Optic disc edema 

Proptosis/enophthalmos 

Retinal detachment 

Retinopathy 

Scleral necrosis/melt 

Uveitis 

Vision-blurred vision 

Vision-flashing lights/floaters 

Vision-photophobia 

Vitreous hemorrhage 

Watery eye (epiphora, tearing) 

Ocular/Visual - Other (Specify, __) 

Category 

OCULAR/VISUAL 

OCULAR/VISUAL 

OCULAR/VISUAL 

OCULAR/VISUAL 

OCULAR/VISUAL 

OCULAR/VISUAL 

NEUROLOGY 

OCULAR/VISUAL 

OCULAR/VISUAL 

OCULAR/VISUAL 

OCULAR/VISUAL 

OCULAR/VISUAL 

OCULAR/VISUAL 

OCULAR/VISUAL 

OCULAR/VISUAL 

OCULAR/VISUAL 

OCULAR/VISUAL 

OCULAR/VISUAL 

OCULAR/VISUAL 

OCULAR/VISUAL 

OCULAR/VISUAL 

Date : 07/15/2003 

- 72 of 101 - 

Cataract 

Dry eye 

Adverse Event 

Ocular/Visual-Other (Specify,___) 

Glaucoma 

Keratitis (corneal inflammation/corneal ulceration) 

Vision-night blindness (nyctalopia) 

Nystagmus 

Conjunctivitis 

Vision-double vision (diplopia) 







Vision-blurred vision 

Vision-flashing lights/floaters 

Vision-photophobia 


Tearing (watery eyes) 






Other Specify 

Eyelid dysfunction 

(10015986) 

Optic disc edema 

(10030916) 

Proptosis/enophthalmos 

(10036905) 

Retinal detachment 

(10038848) 

Retinopathy (10048487) 

Scleral necrosis/melt 

(10039697) 

Uveitis (10046855) 

Vitreous hemorrhage 

(10047655)





Category : PAIN 

Adverse Event 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Abdomen NOS 

Anus 

Back 

Bladder 

Bone 

Breast 

Buttock 

Cardiac/heart 

Chest wall 

Chest/thorax NOS 

Dental/teeth/peridontal 

Esophagus 

External ear 

Select Extremity-limb 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

Category 

Date : 07/15/2003 

- 73 of 101 - 

Abdominal pain or cramping 

Pain-Other (Specify,___) 



Bone pain 





Adverse Event 

Chest pain (non-cardiac and non-pleuritic) 









Other Specify 

Pain: Anus (10052811) 

Pain: Back (10003988) 

Pain: Bladder (10005063) 

Pain: Breast (10006298) 

Pain: Buttock (10048677) 

Pain: Cardiac/heart 

(10002383) 

Pain: Chest wall 

(10008496) 

Pain: 

Dental/teeth/peridontal 

(10044055) 

Pain: Esophagus 

(10030180) 

Pain: External ear 

(90030566) 

Pain: Extremity-limb 

(10033425)






Adverse Event 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Eye 

Face 

Gallbladder 

Select Neck 

Head/headache 

Intestine 

Joint 

Kidney 

Larynx 

Lip 

Liver 

Lymph node 

Middle ear 

Muscle 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

Category 

Date : 07/15/2003 

- 74 of 101 - 




Headache 


Arthralgia (joint pain) 




Hepatic pain 


Earache (otalgia) 

Myalgia (muscle pain) 


Adverse Event 





Other Specify 

Pain: Eye (10015958) 

Pain: Face (10016059) 

Pain: Gallbladder 

(10017638) 

Pain: Intestine (10018000) 

Pain: Kidney (10038490) 

Pain: Larynx (10054115) 

Pain: Lip (10024561) 

Pain: Lymph node 

(10025182) 

Pain: Neck (10028836)






Adverse Event 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Neuralgia/peripheral nerve 

Oral cavity 

Oral-gums 

Ovulatory 

Pain NOS 

Pelvis 

Penis 

Pericardium 

Perineum 

Peritoneum 

Phantom (pain associated with missing limb) 

Pleura 

Prostate 

Select Rectum 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

Category 

Date : 07/15/2003 

- 75 of 101 - 

Adverse Event 

Neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb 

pain, post-infectious neuralgia, or painful neuropathies) 





Pelvic pain 






Pleuritic pain 


Rectal or perirectal pain (proctalgia) 





Other Specify 

Pain: Oral cavity 

(10031009) 

Pain: Oral-gums 

(10018286) 

Pain: Ovulatory 

(10033314) 

Pain: Pain NOS 

(10033470) 

Pain: Penis (10034310) 

Pain: Pericardium 

(90030568) 

Pain: Perineum 

(10034527) 

Pain: Peritoneum 

(90030570) 

Pain: Phantom (pain 

associated with missing 

limb) (10056238) 

Pain: Prostate (10036968)






Adverse Event 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Select 

Pain 

Scalp 

Scrotum 

Sinus 

Skin 

Stomach 

Testicle 

Select Vagina 

Throat/pharynx/larynx 

Tumor pain 

Urethra 

Uterus 

Pain - Other (Specify, __) 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

PAIN 

Category 

Date : 07/15/2003 

- 76 of 101 - 








Adverse Event 

Tumor pain (onset or exacerbation of tumor pain due to 

treatment) 









Other Specify 

Pain: Scalp (90030572) 

Pain: Scrotum (10039757) 

Pain: Sinus (10040747) 

Pain: Skin (10033474) 

Pain: Stomach 

(10042101) 

Pain: Testicle (10043345) 

Pain: 

Throat/pharynx/larynx 

(10034844) 

Pain: Urethra (10046461) 

Pain: Uterus (10046809) 

Pain: Vagina (10046937)





Category : PULMONARY/UPPER RESPIRATORY 

Adverse Event 

Adult Respiratory Distress Syndrome (ARDS) 

Aspiration 

Atelectasis 

Bronchospasm, wheezing 

Carbon monoxide diffusion capacity (DL(co)) 

Chylothorax 

Cough 

Dyspnea (shortness of breath) 

Edema, larynx 

FEV(1) 

Fistula, pulmonary/upper respiratory 

Select 


Select 


Select 


Select 


Select 


Select 

Bronchus 

Larynx 

Lung 

Oral cavity 

Pharynx 

Pleura 



Category 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 


PULMONARY 

PULMONARY 

Date : 07/15/2003 

- 77 of 101 - 

Adverse Event 

Adult respiratory distress syndrome (ARDS) 

Pulmonary-Other (Specify,___) 



Carbon monoxide diffusion capacity (DL(co)) 


Cough 

Dyspnea (shortness of breath) 


FEV (1) 





Fistula-pharyngeal 







Other Specify 

Aspiration (10003504) 

Atelectasis (10003598) 

Bronchospasm, wheezing 

(10006485) 

Chylothorax (10051228) 

Edema, larynx (10023845) 

Fistula, pulmonary/upper 

respiratory: Bronchus 

(10006437) 


respiratory: Larynx 

(90030574) 


respiratory: Lung 

(90030576) 


respiratory: Oral cavity 

(90030578) 


respiratory: Pleura 

(10053481) 


respiratory: Trachea 

(90030580)






Adverse Event 

Hiccoughs (hiccups, singultus) 

Hypoxia 

Nasal cavity/paranasal sinus reactions 

Obstruction/stenosis of airway 

Select 


Select 


Select 

Bronchus 

Larynx 

Pharynx 



Pleural effusion (non-malignant) 

Pneumonitis/pulmonary infiltrates 

Pneumothorax 

Prolonged chest tube drainage or air leak after pulmonary 

resection 

Prolonged intubation after pulmonary resection (>24 hrs 

after surgery) 

Pulmonary fibrosis (radiographic changes) 

Vital capacity 

Voice changes/dysarthria (e.g., hoarseness, loss or 

alteration in voice, laryngitis) 

Category 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

PULMONARY 

Date : 07/15/2003 

- 78 of 101 - 

Hiccoughs (hiccups, singultus) 

Hypoxia 






Pleural effusion (non-malignant) 

Adverse Event 

Pneumonitis/pulmonary infiltrates 

Pneumothorax 



Pulmonary fibrosis 


Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, 

laryngitis) 





Other Specify 

Nasal cavity/paranasal 

sinus reactions 

(90030582) 

Obstruction/stenosis of 

airway: Bronchus 

(10006487) 


airway: Larynx 

(10023862) 


airway: Pharynx 

(90030584) 


airway: Trachea 

(10050816) 

Prolonged chest tube 

drainage or air leak after 

pulmonary resection 

(90030586) 

Prolonged intubation after 

pulmonary resection (>24 

hrs after surgery) 

(90030588) 

Vital capacity (10047582)






Adverse Event 

Pulmonary/Upper Respiratory - Other (Specify, __) 

Category 

PULMONARY Pulmonary-Other (Specify,___) 

Date : 07/15/2003 

- 79 of 101 - 

Adverse Event 





Other Specify





Category : RENAL/GENITOURINARY 

Adverse Event 

Bladder spasms 

Cystitis 

Fistula, GU 

Select 

Fistula, GU 

Select 

Fistula, GU 

Select 

Fistula, GU 

Select 

Fistula, GU 

Select 

Fistula, GU 

Select 

Fistula, GU 

Select 

Incontinence, urinary 

Leak (including anastomotic), GU 

Select 


Select 


Select 

Bladder 

Genital tract-female 

Kidney 

Ureter 

Urethra 

Uterus 

Vagina 

Bladder 


Kidney 


Select Spermatic cord 

Category 















Date : 07/15/2003 

- 80 of 101 - 

Bladder spasms 

Adverse Event 

Renal/Genitourinary-Other (Specify,____) 







Fistula or GU fistula (e.g., vaginal, vesicovaginal) 

Incontinence 









Other Specify 

Cystitis (10011798) 

Fistula, GU: Bladder 

(10047363) 

Fistula, GU: Genital tractfemale 

(10016393) 

Fistula, GU: Kidney 

(10051985) 

Fistula, GU: Ureter 

(10046404) 

Fistula, GU: Urethra 

(10046451) 

Fistula, GU: Uterus 

(90030590) 


anastomotic), GU: Bladder 

(90030594) 


anastomotic), GU: 



anastomotic), GU: Kidney 

(90030598) 


anastomotic), GU: 


(90030600)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 

Obstruction, GU 

Select 


Select 


Select 


Select 


Select 


Select 

Stoma 

Ureter 

Urethra 

Uterus 

Vagina 

Vas deferens 

Bladder 


Prostate 


Select Ureter 


Stoma 

Testes 

Category 














Date : 07/15/2003 

- 81 of 101 - 

Adverse Event 













Ureteral obstruction 





Other Specify 


anastomotic), GU: Stoma 

(90030602) 


anastomotic), GU: Ureter 

(90030604) 


anastomotic), GU: Urethra 

(90030606) 


anastomotic), GU: Uterus 

(90030608) 


anastomotic), GU: Vagina 

(90030610) 


anastomotic), GU: Vas 


Obstruction, GU: Bladder 

(10005060) 

Obstruction, GU: Fallopian 

tube (90030614) 

Obstruction, GU: Prostate 

(10055026) 

Obstruction, GU: 


(90030616) 

Obstruction, GU: Stoma 

(90030618) 

Obstruction, GU: Testes 

(90030620)






Adverse Event 


Select 


Select 


Select 


Select 

Perforation, GU 

Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Urethra 

Uterus 

Vagina 

Vas deferens 

Bladder 


Kidney 

Ovary 

Prostate 


Stoma 

Testes 

Ureter 


Select Urethra 

Category 















Date : 07/15/2003 

- 82 of 101 - 

Adverse Event 



















Other Specify 

Obstruction, GU: Urethra 

(10046459) 

Obstruction, GU: Uterus 

(90030622) 

Obstruction, GU: Vagina 

(90030624) 

Obstruction, GU: Vas 


Perforation, GU: Bladder 

(90030628) 

Perforation, GU: Fallopian 

tube (90030630) 

Perforation, GU: Kidney 

(90030632) 

Perforation, GU: Ovary 

(90030634) 

Perforation, GU: Prostate 

(90030636) 

Perforation, GU: 


(90030638) 

Perforation, GU: Stoma 

(90030640) 

Perforation, GU: Testes 

(90030642) 

Perforation, GU: Ureter 

(90030644) 

Perforation, GU: Urethra 

(90030646)






Adverse Event 


Select 


Select 


Select 

Prolapse of stoma, GU 

Renal failure 

Stricture/stenosis (including anastomotic), GU 

Select 


Select 


Select 


Select 


Select 


Select 

Uterus 

Vagina 

Vas deferens 

Bladder 


Prostate 


Select Ureter 


Stoma 

Testes 

Category 













Date : 07/15/2003 

- 83 of 101 - 

Adverse Event 





Renal failure 












Other Specify 

Perforation, GU: Uterus 

(10046810) 

Perforation, GU: Vagina 

(90030648) 

Perforation, GU: Vas 


Prolapse of stoma, GU 

(90030652) 



GU: Bladder (10005082) 



GU: Fallopian tube 

(90030654) 



GU: Prostate (90030656) 



GU: Spermatic cord 

(90030658) 



GU: Stoma (90030660) 



GU: Testes (90030662) 



GU: Ureter (10046411)






Adverse Event 


Select 


Select 


Select 

Urethra 

Uterus 

Vagina 


Select Vas deferens 

Urinary electrolyte wasting (e.g., Fanconi's syndrome, 

renal tubular acidosis) 

Urinary frequency/urgency 

Urinary retention (including neurogenic bladder) 

Urine color change 

Renal/Genitourinary - Other (Specify, __) 

Category 










Date : 07/15/2003 

- 84 of 101 - 

Adverse Event 





Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal 

tubular acidosis) 

Urinary frequency/urgency 

Urinary retention 

Urine color change (not related to other dietary or physiologic 

cause e.g., bilirubin, concentrated urine, hematuria) 






Other Specify 



GU: Urethra (10046466) 



GU: Uterus (90030664) 



GU: Vagina (10053496) 



GU: Vas deferens 

(90030666)





Category : SECONDARY MALIGNANCY 

Adverse Event 

Secondary Malignancy - possibly related to cancer 

treatment (Specify, __) 

Category 

SECONDARY 

MALIGNANCY 

Date : 07/15/2003 

- 85 of 101 - 

Adverse Event 

Secondary Malignancy-Other (Specify,____) excludes 

metastasis from initial primary 





Other Specify 

Secondary Malignancy - 

possibly related to cancer 

treatment (Specify, __) 

(90004088)





Category : SEXUAL/REPRODUCTIVE FUNCTION 

Adverse Event 

Breast function/lactation 

Breast nipple/areolar deformity 

Breast volume/hypoplasia 

Erectile dysfunction 

Ejaculatory dysfunction 

Gynecomastia 

Infertility/sterility 

COMMENTS 

Category 

v3.0 Infertility/sterility is a merge of v2.0 Female sterility and v2.0 Male infertility. 

Irregular menses (change from baseline) 

SEXUAL/REPRODUCTIVE 

FUNCTION 

Libido 

Orgasmic dysfunction 

Vaginal discharge (non-infectious) 

Vaginal dryness 

Vaginal mucositis 

Vaginal stenosis/length 

Vaginitis (not due to infection) 

Sexual/Reproductive Function - Other (Specify, __) 


FUNCTION 


FUNCTION 


FUNCTION 


FUNCTION 


FUNCTION 

ENDOCRINE 


FUNCTION 


FUNCTION 


FUNCTION 


FUNCTION 


FUNCTION 


FUNCTION 


FUNCTION 



FUNCTION 

Date : 07/15/2003 

- 86 of 101 - 

Adverse Event 

Sexual/Reproductive Function-Other (Specify,___) 



Erectile impotence 


Gynecomastia 


Irregular menses (change from baseline) 

Libido 



Vaginal dryness 



Vaginitis (not due to infection) 






Other Specify 

Breast function/lactation 

(90030668) 

Breast nipple/areolar 

deformity (90030670) 

Breast volume/hypoplasia 

(10049070) 

Ejaculatory dysfunction 

(10014327) 

Infertility/sterility 

(10021930) 

Orgasmic dysfunction 

(10031085) 

Vaginal discharge (noninfectious) 

(10046901) 

Vaginal mucositis 

(90030672) 

Vaginal stenosis/length 

(10046879)





Category : SURGERY/INTRA-OPERATIVE INJURY 

Adverse Event 

Intra-operative injury 

Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Abdomen NOS 

Adrenal gland 

Anal sphincter 

Anus 

Appendix 

Artery NOS 

Artery-aorta 

Artery-carotid 

Artery-cerebral 

Artery-extremity (lower) 

Artery-extremity (upper) 

Artery-hepatic 


Select Artery-major visceral artery 

Category 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 

Date : 07/15/2003 

- 87 of 101 - 

Adverse Event 


















Other Specify 

Intra-operative injury: 

Abdomen NOS 

(90030674) 


Adrenal gland (90030676) 

Intra-operative injury: Anal 

sphincter (90030678) 


Anus (90030680) 


Appendix (90030682) 


Artery NOS (90030684) 


Artery-aorta (90030686) 


Artery-carotid (90030688) 


Artery-cerebral 

(90030690) 


Artery-extremity (lower) 

(90030692) 


Artery-extremity (upper) 

(90030694) 


Artery-hepatic (90030696) 


Artery-major visceral 

artery (90030698)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select Cecum 

Artery-pulmonary 

Biliary tree NOS 

Biliary tree-common bile duct 

Biliary tree-common hepatic duct 

Biliary tree-left hepatic duct 

Biliary tree-right hepatic duct 

Bladder 

Bone 

Brain 

Breast 

Bronchus 

Cartilage 

Category 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 

Date : 07/15/2003 

- 88 of 101 - 

Adverse Event 


















Other Specify 


Artery-pulmonary 

(90030700) 


Biliary tree NOS 

(90030702) 


Biliary tree-common bile 

duct (90030704) 


Biliary tree-common 

hepatic duct (90030706) 


Biliary tree-left hepatic 

duct (90030708) 


Biliary tree-right hepatic 

duct (90030710) 


Bladder (90030712) 


Bone (90030714) 


Brain (90030716) 


Breast (90030718) 


Bronchus (90030720) 


Cartilage (90030722) 


Cecum (90030724)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Cervix 

Colon 

Conjunctiva 

Cornea 

Duodenum 

Esophagus 



Eye NOS 

Face NOS 


Gallbladder 


Select Gingiva 

Category 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 

Date : 07/15/2003 

- 89 of 101 - 

Adverse Event 


















Other Specify 


Cervix (90030726) 


Colon (90030728) 


Conjunctiva (90030730) 


Cornea (90030732) 







(90030738) 



(90030740) 

Intra-operative injury: Eye 

NOS (90030742) 


Face NOS (90030744) 






Gingiva (90030750)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Heart 

Ileum 

Inner ear 

Jejunum 

Joint 

Kidney 

Larynx 

Lens 

Ligament 

Lip/perioral area 

Liver 

Lung 

Mediastinum 


Select Meninges 

Category 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 

Date : 07/15/2003 

- 90 of 101 - 

Adverse Event 



















Other Specify 


Heart (90030752) 


Ileum (90030754) 


Inner ear (90030756) 


Jejunum (90030758) 


Joint (90030760) 


Kidney (90030762) 


Larynx (90030764) 


Lens (90030766) 


Ligament (90030768) 


Lip/perioral area 

(90030770) 


Liver (90030772) 


Lung (90030774) 


Mediastinum (90030776) 


Meninges (90030778)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Middle ear 

Muscle 

Nails 

Nasal cavity 

Nasopharynx 

Neck NOS 

NERVES: Brachial plexus 

NERVES: CN I (olfactory) 

NERVES: CN II (optic) 

NERVES: CN III (oculomotor) 

NERVES: CN IV (trochlear) 

NERVES: CN IX (glossopharyngeal) motor 

pharynx 

Category 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 

Date : 07/15/2003 

- 91 of 101 - 

Adverse Event 

















Other Specify 


Middle ear (90030780) 


Muscle (90030782) 


Nails (90030834) 


Nasal cavity (90030836) 


Nasopharynx (90030838) 


Neck NOS (90030840) 


NERVES: Brachial plexus 

(90030784) 


NERVES: CN I (olfactory) 

(90030786) 


NERVES: CN II (optic) 

(90030788) 


NERVES: CN III 

(oculomotor) (90030790) 


NERVES: CN IV 

(trochlear) (90030792) 


NERVES: CN IX 

(glossopharyngeal) motor 

pharynx (90030794)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

NERVES: CN IX (glossopharyngeal) sensory earpharynx-tongue 

NERVES: CN V (trigeminal) motor 

NERVES: CN V (trigeminal) sensory 

NERVES: CN VI (abducens) 

NERVES: CN VII (facial) motor-face 

NERVES: CN VII (facial) sensory-taste 

NERVES: CN VIII (vestibulocochlear) 

NERVES: CN X (vagus) 

NERVES: CN XI (spinal accessory) 


Select NERVES: CN XII (hypoglossal) 

Category 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 

Date : 07/15/2003 

- 92 of 101 - 

Adverse Event 















Other Specify 


NERVES: CN IX 

(glossopharyngeal) 

sensory ear-pharynxtongue 

(90030796) 


NERVES: CN V 

(trigeminal) motor 

(90030798) 


NERVES: CN V 

(trigeminal) sensory 

(90030800) 


NERVES: CN VI 

(abducens) (90030802) 


NERVES: CN VII (facial) 

motor-face (90030804) 


NERVES: CN VII (facial) 

sensory-taste (90030806) 


NERVES: CN VIII 

(vestibulocochlear) 

(90030808) 


NERVES: CN X (vagus) 

(90030810) 


NERVES: CN XI (spinal 

accessory) (90030812) 


NERVES: CN XII 

(hypoglossal) (90030814)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

NERVES: Cranial nerve or branch NOS 

NERVES: Lingual 

NERVES: Lung thoracic 

NERVES: Peripheral motor NOS 

NERVES: Peripheral sensory NOS 

NERVES: Recurrent laryngeal 

NERVES: Sacral plexus 

NERVES: Sciatic 

NERVES: Thoracodorsal 

Nose 

Oral 


Select Oral cavity NOS 

Category 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 

Date : 07/15/2003 

- 93 of 101 - 

Adverse Event 

















Other Specify 


NERVES: Cranial nerve or 

branch NOS (90030816) 


NERVES: Lingual 

(90030818) 


NERVES: Lung thoracic 

(90030820) 


NERVES: Peripheral 

motor NOS (90030822) 


NERVES: Peripheral 

sensory NOS (90030824) 


NERVES: Recurrent 

laryngeal (90030826) 


NERVES: Sacral plexus 

(90030828) 


NERVES: Sciatic 

(90030830) 


NERVES: Thoracodorsal 

(90030832) 


Nose (90030842) 

Intra-operative injury: Oral 

(90030844) 

Intra-operative injury: Oral 

cavity NOS (90030846)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select Pleura 

Outer ear NOS 

Outer ear-Pinna 

Ovary 

Pancreas 

Pancreatic duct 

Parathyroid 

Parotid gland 

Pelvis NOS 

Penis 


Pharynx 

Pituitary 

Category 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 

Date : 07/15/2003 

- 94 of 101 - 

Adverse Event 


















Other Specify 


Outer ear NOS 

(90030848) 


Outer ear-Pinna 

(90030850) 


Ovary (90030852) 




Pancreatic duct 

(90030856) 


Parathyroid (90030858) 


Parotid gland (90030860) 


Pelvis NOS (90030862) 


Penis (90030864) 



(90030866) 


Pharynx (90030868) 


Pituitary (90030870) 


Pleura (90030872)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Prostate 

Rectum 

Retina 

Salivary duct 


Scrotum 

Sinus 

Skin 



Spinal cord 

Spleen 

Stoma (GI) 


Select Stomach 

Category 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 

Date : 07/15/2003 

- 95 of 101 - 

Adverse Event 



















Other Specify 


Prostate (90030874) 


Rectum (90030876) 


Retina (90030878) 


Salivary duct (90030880) 


Salivary gland (90030882) 


Scrotum (90030884) 


Sinus (90030886) 

Intra-operative injury: Skin 

(90030888) 



(90030890) 

Intra-operative injury: Soft 

tissue NOS (90030892) 


Spinal cord (90030894) 


Spleen (90030896) 


Stoma (GI) (90030898) 


Stomach (90030900)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Teeth 

Tendon 

Testis 

Thoracic duct 

Thyroid 

Tongue 

Trachea 



Ureter 

Urethra 

Urinary conduit 


Select Urinary tract NOS 

Category 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 

Date : 07/15/2003 

- 96 of 101 - 

Adverse Event 


















Other Specify 


Teeth (90030902) 


Tendon (90030904) 


Testis (90030906) 


Thoracic duct (90030908) 


Thyroid (90030910) 


Tongue (90030912) 


Trachea (90030914) 



(90030916) 



(90030918) 


Ureter (90030920) 


Urethra (90030922) 


Urinary conduit 

(90030924) 



(90030926)






Adverse Event 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 


Select 

Uterus 

Vagina 

Vein NOS 


Select Vulva 

Vein-extremity (lower) 

Vein-extremity (upper) 

Vein-hepatic 

Vein-inferior vena cava 

Vein-jugular 

Vein-major visceral vein 

Vein-portal vein 

Vein-pulmonary 

Vein-superior vena cava 

Category 


SYMPTOMS 


SYMPTOMS 


(GENERAL) 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 

Date : 07/15/2003 

- 97 of 101 - 

Adverse Event 



Operative injury of vein/artery 















Other Specify 


Uterus (90030928) 


Vagina (90030930) 


Vein-extremity (lower) 

(90030932) 


Vein-extremity (upper) 

(90030934) 


Vein-hepatic (90030936) 


Vein-inferior vena cava 

(90030938) 


Vein-jugular (90030940) 


Vein-major visceral vein 

(90030942) 


Vein-portal vein 

(90030944) 


Vein-pulmonary 

(90030946) 


Vein-superior vena cava 

(90030948) 


Vulva (90030950)






Adverse Event 

Intra-operative Injury - Other (Specify, __) 

Category 


SYMPTOMS 

Date : 07/15/2003 

- 98 of 101 - 

Adverse Event 






Other Specify 

Intra-operative Injury - 

Other (Specify, __)





Category : SYNDROMES 

Adverse Event 

Flu-like syndrome 

Alcohol intolerance syndrome (antabuse-like syndrome) 

Cytokine release syndrome/acute infusion reaction 

"Retinoic acid syndrome" 

Tumor flare 

Tumor lysis syndrome 

Syndromes - Other (Specify, __) 

Category 

SYNDROMES 

SYNDROMES 

SYNDROMES 

SYNDROMES 

SYNDROMES 

SYNDROMES 

SYNDROMES 

Date : 07/15/2003 

- 99 of 101 - 

Adverse Event 

Syndromes-Other (Specify,_____) 




Tumor flare 

Tumor lysis syndrome 






Other Specify 

Flu-like syndrome 

(10022004) 

Alcohol intolerance 

syndrome (antabuse-like 

syndrome) (10001598) 

Cytokine release 

syndrome/acute infusion 

reaction (10052015) 

"Retinoic acid syndrome" 

(10038921)





Category : VASCULAR 

Adverse Event 

Acute vascular leak syndrome 

Peripheral arterial ischemia 

Phlebitis (including superficial thrombosis) 

Portal vein flow 

Thrombosis/embolism (vascular access-related) 

Thrombosis/thrombus/embolism 

Vessel injury-artery 

Select 


Select 


Select 


Select 


Select 


Select 

Vessel injury-vein 

Select 

Aorta 

Carotid 



Other NOS 

Visceral 



Select Extremity-upper 

Category 


(GENERAL) 


(GENERAL) 


(GENERAL) 

HEPATIC 


SYMPTOMS 


(GENERAL) 


SYMPTOMS 


SYMPTOMS 

COAGULATION 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 

Date : 07/15/2003 

- 100 of 101 - 

Acute vascular leak syndrome 

Peripheral arterial ischemia 

Phlebitis (superficial) 

Portal vein flow 

Adverse Event 


Thrombosis/embolism 



Coagulation-Other (Specify,_____) 










Other Specify 

Thrombosis/embolism 

(vascular access-related) 

(10051094) 

Vessel injury-artery: Aorta 

(90030956) 

Vessel injury-artery: 

Carotid (90030958) 



(90030960) 



(90030962) 

Vessel injury-artery: Other 

NOS (90030964) 


Visceral (90030966) 

Vessel injury-vein: 


(90030968) 

Vessel injury-vein: 


(90030970)





Category : VASCULAR 

Adverse Event 


Select 


Select 


Select 


Select 

IVC 

Jugular 

Other NOS 

SVC 


Select Viscera 

Visceral arterial ischemia (non-myocardial) 

Vascular - Other (Specify, __) 

Category 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


SYMPTOMS 


(GENERAL) 


SYMPTOMS 

Date : 07/15/2003 

- 101 of 101 - 

Adverse Event 






Visceral arterial ischemia (non-myocardial) 






Other Specify 

Vessel injury-vein: IVC 

(90030972) 

Vessel injury-vein: Jugular 

(90030974) 

Vessel injury-vein: Other 

NOS (90030976) 

Vessel injury-vein: SVC 

(90030978) 

Vessel injury-vein: Viscera 

(90030980)

Cancer Therapy Evaluation Program 3.0 CTCAE Version From 2.0 ...

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