INSTRUCTIONS: Complete this form as indicated below and at the end of all protocol therapy. Submit original to the ECOG Coordinating Center. Keep a copy for your files.

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ECOG clinical trial administrative data
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Data amended
Item
Are data amended (If yes, please circle amended items in red.)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Patient demographics
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
On Treatment
Item
On Treatment Report Period (Arm B Only)
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
Code List
On Treatment Report Period (Arm B Only)
CL Item
Cycle 18 (Cycle 18)
CL Item
End Of Second 12 Cycles Of Treatment (End of Second 12 Cycles of Treatment)
Item Group
Off Treatment
Item
Off Treatment Report Period (since initial registration)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25601 (NCI Thesaurus Property-2)
C1518544 (UMLS 2011AA Property-2)
C25207 (NCI Thesaurus Property-3)
C0040223 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Off Treatment Report Period (since initial registration)
CL Item
3 Months (3 Months Post Registration)
CL Item
6 Months (6 Months Post Registration)
CL Item
9 Months (9 Months Post Registration)
CL Item
12 Months (12 Months Post Registration)
CL Item
15 Months (15 Months Post Registration)
CL Item
18 Months (18 Months Post Registration)
CL Item
21 Months Post Registration (21 Months Post Registration)
CL Item
2 Years (24 Months Post Registration)
CL Item
30 Months (30 Months Post Registration)
CL Item
3 Years (36 Months Post Registration)
CL Item
42 Months (42 Months Post Registration)
CL Item
4 Years (48 Months Post Registration)
CL Item
54 Months (54 Months Post Registration)
CL Item
5 Years (60 Months Post Registration)
CL Item
6 Years (72 Months Post-Registration)
CL Item
84 Months Post Registration (84 Months Post-Registration)
CL Item
8 Years (96 Months Post-Registration)
CL Item
9 Years (108 Months Post-Registration)
CL Item
10 Years (120 Months Post-Registration)
Item Group
Adverse event assessment
Item
Were adverse events assessed during this report period (cycle)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
Code List
Were adverse events assessed during this report period (cycle)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, But No Reportable Adverse Events Occurred (Yes, but no reportable adverse events occurred)
CL Item
Yes, And Reportable Adverse Events Occurred (Yes, and reportable adverse events occurred)
Adverse Event Start Date
Item
CTC Adverse Event Report Begin Date
date
C25164 (NCI Thesaurus ValueDomain)
C2697888 (UMLS CUI-1)
C25375 (NCI Thesaurus Property)
C25431 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
Adverse Event End Date
Item
CTC Adverse Event Report End Date
date
C25164 (NCI Thesaurus ValueDomain)
C2697886 (UMLS CUI-1)
C25375 (NCI Thesaurus Property)
C49704 (NCI Thesaurus ObjectClass)
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
Code List
CTC Adverse Event Term
CL Item
Haemoglobin Decreased (Hemoglobin)
C0162119 (NCI Metathesaurus)
CL Item
Leucopenia Nos (Leukocytes (total WBC))
CL Item
Neutropenia (Neutrophils/granulocytes (ANC/AGC))
C3277 (NCI Thesaurus)
CL Item
Platelet Count Decreased (Platelets)
C0392386 (NCI Metathesaurus)
CL Item
Hypersensitivity Nos (Allergic reaction/hypersensitivity (including drug fever))
CL Item
Arrhythmia Nos (Cardiac Arrhythmia - Other)
CL Item
Myocardial Ischaemia (Cardiac ischemia/infarction)
C0151744 (NCI Metathesaurus)
CL Item
Cerebral Ischaemia (CNS cerebrovascular ischemia)
C0917798 (NCI Metathesaurus)
CL Item
Thrombosis/embolism (vascular Access-related) (Thrombosis/embolism (vascular access-related))
CL Item
Phlebitis Superficial (Phlebitis (including superficial thrombosis))
C0750876 (NCI Metathesaurus)
CL Item
Thrombosis Nos (Thrombosis/thrombus/embolism)
CL Item
Haemorrhagic Stroke (Hemorrhage, CNS)
CL036983 (NCI Metathesaurus)
CL Item
Coagulation Disorder Nos (Coagulation - Other)
CL Item
Febrile Neutropenia (fever Of Unknown Origin Without Clinically Or Microbiologically Documented Infection) (anc <1.0 X 10^9/l, Fever >=38.5 Degrees C) (Febrile neutropenia)
CL Item
Pyrexia (Fever (in absence of neutropenia, where neutropenia is defined as ANC <1000))
CL Item
Rectal Bleeding (Hemorrhage, GI - Rectum)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Stomach)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Lower GI NOS)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Upper GI NOS)
CL Item
Haematuria Present (Hemorrhage, GU - Urinary NOS)
CL Item
Epistaxis (Hemorrhage, pulmonary/upper respiratory - Nose)
C26766 (NCI Thesaurus)
C0014591 (UMLS 2011AA)
CL Item
Haemoptysis (Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS)
CL Item
Hemorrhage/bleeding Other (Hemorrhage/Bleeding - Other)
CL Item
Alopecia (Hair loss/alopecia (head or body))
C2865 (NCI Thesaurus)
CL Item
Fatigue (Fatigue (asthenia, lethargy, malaise))
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Rigors (Rigors/Chills)
C0424790 (NCI Metathesaurus)
CL Item
Hearing: Patients Without Baseline Audiogram And Not Enrolled In A Monitoring Program (Hearing: patients without baseline audiogram and not enrolled in a monitoring program)
CL Item
Otitis Media Serous Nos (Otitis, middle ear (non-infectious))
C0271453 (NCI Metathesaurus)
CL Item
Hypertension Nos (Hypertension)
CL Item
Proteinuria Present (Proteinuria)
CL Item
Peripheral Sensory Neuropathy (Neuropathy: sensory)
C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)
CL Item
Neurology Other (Neurology - Other)
CL Item
Abdominal Pain Nos (Pain - Abdomen NOS)
CL Item
Myalgia (Pain - Muscle)
C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)
CL Item
Headache Nos (Pain - Head/headache)
CL Item
Cough (Cough)
C37935 (NCI Thesaurus)
C0010200 (UMLS 2011AA)
CL Item
Dyspnoea Nos (Dyspnea (shortness of breath))
CL Item
Pulmonary Fibrosis (Pulmonary fibrosis (radiographic changes))
C26869 (NCI Thesaurus)
C0034069 (UMLS 2011AA)
CL Item
Pneumonitis Nos (Pneumonitis/pulmonary infiltrates)
CL Item
Dermatitis Exfoliative Nos (Rash/desquamation)
CL Item
Localised Exfoliation (Rash: hand-foot skin reaction)
CL Item
Culture Wound Negative (Wound complication, non-infectious)
CL040841 (NCI Metathesaurus)
CL Item
Vomiting Nos (Vomiting)
CL Item
Anorexia (Anorexia)
C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)
CL Item
Fistula, Gi (Fistula, GI - Rectum)
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Ileus (Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation))
C37979 (NCI Thesaurus)
C1258215 (UMLS 2011AA)
CL Item
Diarrhoea Nos (Diarrhea)
CL Item
Dehydration (Dehydration)
C26740 (NCI Thesaurus)
C0011175 (UMLS 2011AA)
CL Item
Perforation, Gi (Perforation, GI - Small bowel NOS)
CL Item
Mucositis/stomatitis (clinical Exam) (Mucositis/stomatitis (clinical exam) - Oral cavity)
CL Item
Stomatitis (Mucositis/stomatitis (clinical exam) - Pharynx)
C26887 (NCI Thesaurus)
C0038362 (UMLS 2011AA)
CL Item
Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Oral cavity)
CL Item
Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Pharynx)
CommonToxicityCriteriaAdverseEventOtherArrhythmiaSpecify
Item
Cardiac Arrhythmia - Other Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C2881 (NCI Thesaurus Property-2)
C0003811 (UMLS 2011AA Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CommonToxicityCriteriaAdverseEventOtherCoagulationSpecify
Item
Coagulation - Other Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C20812 (NCI Thesaurus Property-2)
C0005778 (UMLS 2011AA Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CommonToxicityCriteriaAdverseEventOtherHemorrhageSpecify
Item
Hemorrhage/Bleeding - Other Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C26791 (NCI Thesaurus Property-2)
C0019080 (UMLS 2011AA Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CommonToxicityCriteriaAdverseEventOtherNeurologicSpecify
Item
Neurology - Other Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25262 (NCI Thesaurus Property-2)
C0205494 (UMLS 2011AA Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CTC Adverse Event Grade
Item
CTC Adverse Event Grade (this report period)
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Item
CTC Adverse Event Attribution Scale
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
CTC Adverse Event Attribution Scale
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possible (possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (definite)
CL209464 (NCI Metathesaurus)
Item Group
III. INFECTIONS
Item
Common Toxicity (Specify site for each event)
text
C25364 (NCI Thesaurus Property)
C49704 (NCI Thesaurus ObjectClass)
C0332307 (NCI Metathesaurus ValueDomain)
C25249 (NCI Thesaurus Property-2)
C0600091 (UMLS CUI-1)
C1516728 (UMLS CUI-2)
C1806781 (UMLS CUI-3)
Code List
Common Toxicity (Specify site for each event)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (CTC Adverse Event Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC < 1.0 X 10^9/L) - Select Grade)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (CTC Adverse Event Infection with normal ANC or Grade 1 or 2 neutrophils - Select Grade)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Select Grade)
CTC Adverse Event Term
Item
Specify site
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C38024 (NCI Thesaurus Property)
C45559 (NCI Thesaurus Property-2)
Item Group
Other Adverse Events
CTC Adverse Event Term
Item
Other CTC Adverse Event Term not listed
text
C25685 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
CTC Adverse Event Reported Term
Item
Other, Specify (site or subterm)
text
C25685 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2699044 (UMLS CUI-2)
C25161 (NCI Thesaurus Property)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)

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