ID

9584

Description

SOUTHWEST ONCOLOGY GROUP Induction Adverse Event Summary Form (S0521) Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=02C81B59-5981-2968-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=02C81B59-5981-2968-E044-0003BA3F9857

Keywords

Versions (4)
  1. 9/19/12 9/19/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
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January 9, 2015

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Creative Commons BY-NC 3.0 Legacy
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Leukemia NCT00492856 Toxicity - SOUTHWEST ONCOLOGY GROUP Induction Adverse Event Summary Form (S0521) - 2415259v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP Induction Adverse Event Summary Form (S0521)
    1. No Instruction available.
Header
Description

Header

SWOG Patient ID
Description

Trial subject ID SWOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
SWOG Study No.
Description

Protocol ID SWOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
Registration Step
Description

Registration Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Patient Initials (L, F M)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Reporting Period Start Date
Description

Reporting Period Start Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Institution/Affiliate
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Physician (Participating Group:)
Description

Investigator Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2826892
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
NCI Thesaurus ObjectClass-2
C25644
Participating Group Name
Description

Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Description

Study Number Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID (Instructions: All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across the top of the form.)
Description

Trial subject ID Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Adverse Events
Description

Adverse Events

Date of Most Recent Adverse Event Assessment
Description

AdverseEventMostRecentAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property-2
C25577
UMLS 2011AA Property-2
C1513491
Were adverse events assessed during this report period?
Description

AdverseEventCurrentAssessmentInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
CTC Adverse Event Term
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTC Adverse Event Term Other
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTC Adverse Event Grade
Description

CTC Adverse Event Grade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
CTC AE Attribution Code
Description

CTC Adverse Event Attribution Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Comments
Description

Comments

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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1 forms
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP Induction Adverse Event Summary Form (S0521)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Trial subject ID SWOG
Item
SWOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Protocol ID SWOG
Item
SWOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-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)
Patient Initials
Item
Patient Initials (L, F M)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Reporting Period Start Date
Item
Reporting Period Start Date
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-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)
Investigator Name
Item
Physician (Participating Group:)
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
Item
Participating Group Name
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
CL.1
Code List
Participating Group Name
CL Item
American College Of Surgeons Oncology Group (ACOSOG)
C19712 (NCI Thesaurus)
C1515944 (UMLS 2011AA)
CL Item
American College Of Radiology Oncologic Imaging Network (ACRIN)
CL Item
Aids-associated Malignancies Clinical Trials Consortium (AMC)
CL Item
Cancer And Leukemia Group B (CALGB)
C25442 (NCI Thesaurus)
C1516238 (UMLS 2011AA)
CL Item
Children's Oncology Group (COG)
C39353 (NCI Thesaurus)
C1516477 (UMLS 2011AA)
CL Item
Eastern Cooperative Oncology Group (ECOG)
C25491 (NCI Thesaurus)
C1512162 (UMLS 2011AA)
CL Item
European Organization For Research And Treatment Of Cancer (EORTC)
C19741 (NCI Thesaurus)
C1516985 (UMLS 2011AA)
CL Item
Gynecologic Oncology Group (GOG)
C25521 (NCI Thesaurus)
C1512288 (UMLS 2011AA)
CL Item
International Breast Cancer Study Group (IBCSG)
C25530 (NCI Thesaurus)
C1512890 (UMLS 2011AA)
CL Item
North American Brain Tumor Consortium (NABTC)
C37995 (NCI Thesaurus)
C1518418 (UMLS 2011AA)
CL Item
Nabtt Brain Tumor Consortium (NABTT)
CL Item
North Central Cancer Treatment Group (NCCTG)
C25581 (NCI Thesaurus)
C1518419 (UMLS 2011AA)
CL Item
National Cancer Institute Of Canada Clinical Trials Group (NCIC)
C39467 (NCI Thesaurus)
C1513885 (UMLS 2011AA)
CL Item
National Surgical Adjuvant Breast And Bowel Project (NSABP)
C15818 (NCI Thesaurus)
C1513905 (UMLS 2011AA)
CL Item
Radiation Therapy Oncology Group (RTOG)
C19778 (NCI Thesaurus)
C1514695 (UMLS 2011AA)
CL Item
Southwest Oncology Group (SWOG)
C25699 (NCI Thesaurus)
C1519429 (UMLS 2011AA)
Study Number Participating Group
Item
Participating Group Study No.
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)
Trial subject ID Participating Group
Item
Participating Group Patient ID (Instructions: All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across the top of the form.)
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
Adverse Events
AdverseEventMostRecentAssessmentDate
Item
Date of Most Recent Adverse Event Assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus Property-2)
C1513491 (UMLS 2011AA Property-2)
Item
Were adverse events assessed during this report period?
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)
CL.2
Code List
Were adverse events assessed during this report period?
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)
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)
CL.3
Code List
CTC Adverse Event Term
CL Item
Hypersensitivity Nos (Allergic reaction/hypersensitivity (including drug fever))
CL Item
Disseminated Intravascular Coagulation (DIC (disseminated intravascular coagulation))
C2992 (NCI Thesaurus)
C0012739 (UMLS 2011AA)
CL Item
Fatigue (Fatigue (asthenia, lethargy, malaise))
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Pyrexia (Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L))
CL Item
Rigors (Rigors/chills)
C0424790 (NCI Metathesaurus)
CL Item
Chelitis (Cheilitis)
CL Item
Dry Skin (Dry skin)
C0151908 (NCI Metathesaurus)
CL Item
Alopecia (Hair loss/Alopecia (scalp or body))
C2865 (NCI Thesaurus)
CL Item
Pruritus Nos (Pruritus/itching)
CL Item
Dermatitis Exfoliative Nos (Rash/desquamation)
CL Item
Anorexia (Anorexia)
C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)
CL Item
Diarrhoea Nos (Diarrhea)
CL Item
Mucositis/stomatitis (clinical Exam) (Mucositis/stomatitis (clinical exam) - Oral cavity)
CL Item
Mucositis/stomatitis (clinical Exam) (Mucositis/stomatitis (clinical exam) - Rectum)
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Vomiting Nos (Vomiting)
CL Item
Petechiae (Petechiae/purpura (hemorrhage/bleeding into skin or mucosa))
CL Item
Hepatic Failure (Liver dysfunction/failure (clinical))
C26922 (NCI Thesaurus)
C0085605 (UMLS 2011AA)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumonia))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Blood)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia))
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
Alanine Aminotransferase Increased (ALT, SGPT (serum glutamic pyruvic transaminase))
C26948 (NCI Thesaurus)
C0151905 (UMLS 2011AA)
CL Item
Aspartate Aminotransferase Increased (AST, SGOT (serum glutamic oxaloacetic transaminase))
C26947 (NCI Thesaurus)
C0151904 (UMLS 2011AA)
CL Item
Blood Bilirubin Increased (Bilirubin (hyperbilirubinemia))
CL039714 (NCI Metathesaurus)
CL Item
Hypercholesteraemia (Cholesterol, serum-high (hypercholesteremia))
CL Item
Hypertriglyceridaemia (Triglyceride, serum-high (hypertriglyceridemia))
C0020557 (NCI Metathesaurus)
CL Item
Headache Nos (Pain - Head/headache)
CL Item
Myalgia (Pain - Muscle)
C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)
CL Item
Dyspnoea Nos (Dyspnea (shortness of breath))
CL Item
Renal Failure Nos (Renal failure)
CL Item
Retinoic Acid Syndrome (aaRetinoic acid syndrome")
CL044783 (NCI Metathesaurus)
CTC Adverse Event Term
Item
CTC Adverse Event Term Other
text
C25685 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
CTC Adverse Event Grade
Item
CTC Adverse Event Grade
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Item
CTC AE Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.5
Code List
CTC AE Attribution Code
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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