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  1. StudyEvent: Southwest Oncology Group S0777 Induction and Maintenance Adverse Event Summary Form
    1. No Instruction available.
Header
Description

Header

SWOG Patient ID
Description

Trial subject ID SWOG

Data type

float

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
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
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
Cycle completed
Description

TreatmentCycleCompleteName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ObjectClass
C25472
UMLS 2011AA ObjectClass
C1511572
NCI Thesaurus ObjectClass-2
C15368
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
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
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

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
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 time 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

CommonToxicityCriteriaAdverseEventTermType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTC AE Grade (3.0 1-5)
Description

CommonToxicityCriteriaAdverseEventGrade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTC Adverse Event Attribution Code (* Attribution codes: 1-unrelated 2-unlikely 3-possible 4-probably 5-definite)
Description

CTCAdverseEventAttributionScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
CTC Adverse Event Term Other (specify using CTCAE 3.0 terminology)
Description

CTCAdverseEventTermSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
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 S0777 Induction and Maintenance Adverse Event Summary Form
    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
float
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)
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)
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)
Item
Cycle completed
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25472 (NCI Thesaurus ObjectClass)
C1511572 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
CL.1
Code List
Cycle completed
CL Item
Induction (Induction)
CL042203 (NCI Metathesaurus)
CL Item
Maintenance Therapy (Maintenance)
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
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
Participating Group
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)
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
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
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)
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 time 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 time 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)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
CL.3
Code List
CTC Adverse Event Term
CL Item
Vasculitis Nos (Vasculitis)
CL Item
Rhinitis Allergic Nos (Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip))
C0002103 (NCI Metathesaurus)
CL Item
Tinnitus (Tinnitus)
C50772 (NCI Thesaurus)
C0040264 (UMLS 2011AA)
CL Item
Haemoglobin Decreased (Hemoglobin)
C0162119 (NCI Metathesaurus)
CL Item
Sinus Bradycardia (Supraventricular and nodal arrhythmia - Sinus bradycardia)
C26923 (NCI Thesaurus)
C0085610 (UMLS 2011AA)
CL Item
Pericardial Effusion (Pericardial effusion (non-malignant))
C3319 (NCI Thesaurus)
C0031039 (UMLS 2011AA)
CL Item
Insomnia Nec (Insomnia)
CL Item
Dry Skin (Dry skin)
C0151908 (NCI Metathesaurus)
CL Item
Flushing (Flushing)
C26775 (NCI Thesaurus)
C0016382 (UMLS 2011AA)
CL Item
Injection Site Reaction Nos (Injection site reaction/extravasation changes)
CL Item
Pruritus Nos (Pruritus/itching)
CL Item
Erythema Multiforme (Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis))
C3024 (NCI Thesaurus)
C0014742 (UMLS 2011AA)
CL Item
Hypothyroidism (Thyroid function, low (hypothyroidism))
C26800 (NCI Thesaurus)
C0020676 (UMLS 2011AA)
CL Item
Constipation (Constipation)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Dry Mouth (Dry mouth/salivary gland (xerostomia))
C26917 (NCI Thesaurus)
C0043352 (UMLS 2011AA)
CL Item
Oesophagitis Nos (Esophagitis)
CL Item
Ileus (Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation))
C37979 (NCI Thesaurus)
C1258215 (UMLS 2011AA)
CL Item
Taste Disturbance (Taste alteration (dysgeusia))
CL Item
Pancreatitis Nos (Pancreatitis)
CL Item
Edema: Head And Neck (Edema: head and neck)
CL Item
Oedema Nos (Edema: limb)
CL Item
Hypertension Nos (Hypertension)
CL Item
Hypotension Nos (Hypotension)
CL Item
Weight Decreased (Weight loss)
CL Item
Urticaria Nos (Urticaria (hives, welts, wheals))
CL Item
Blood Alkaline Phosphatase Nos Increased (Alkaline phosphatase)
CL Item
Alanine Aminotransferase Increased (ALT, SGPT (serum glutamic pyruvic transaminase))
C26948 (NCI Thesaurus)
C0151905 (UMLS 2011AA)
CL Item
Anorexia (Anorexia)
C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)
CL Item
Dehydration (Dehydration)
C26740 (NCI Thesaurus)
C0011175 (UMLS 2011AA)
CL Item
Aspartate Aminotransferase Increased (AST, SGOT (serum glutamic oxaloacetic transaminase))
C26947 (NCI Thesaurus)
C0151904 (UMLS 2011AA)
CL Item
Blood Creatinine Increased (Creatinine)
C0235431 (NCI Metathesaurus)
CL Item
Hypercalcaemia (Calcium, serum-high (hypercalcemia))
CL Item
Hypocalcaemia (Calcium, serum-low (hypocalcemia))
CL Item
Hyperglycaemia Nos (Glucose, serum-high (hyperglycemia))
CL Item
Hypoglycaemia Nos (Glucose, serum-low (hypoglycemia))
CL Item
Lipase Increased (Lipase)
C0549475 (NCI Metathesaurus)
CL Item
Gamma-glutamyltransferase Increased (GGT (gamma-glutamyl transpeptidase))
C26943 (NCI Thesaurus)
C0151662 (UMLS 2011AA)
CL Item
Blood Magnesium Decreased (Magnesium, serum-low (hypomagnesemia))
CL039365 (NCI Metathesaurus)
CL Item
Hypophosphataemia (Phosphate, serum-low (hypophosphatemia))
C0085682 (NCI Metathesaurus)
CL Item
Diarrhoea Nos (Diarrhea)
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
Flatulence (Flatulence)
C37954 (NCI Thesaurus)
C0016204 (UMLS 2011AA)
CL Item
Dyspepsia (Heartburn/dyspepsia)
C26756 (NCI Thesaurus)
C0013395 (UMLS 2011AA)
CL Item
Haemorrhagic Stroke (Hemorrhage, CNS)
CL036983 (NCI Metathesaurus)
CL Item
Leucopenia Nos (Leukocytes (total WBC))
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Neutropenia (Neutrophils/granulocytes (ANC/AGC))
C3277 (NCI Thesaurus)
CL Item
Cerebral Ischaemia (CNS cerebrovascular ischemia)
C0917798 (NCI Metathesaurus)
CL Item
Platelet Count Decreased (Platelets)
C0392386 (NCI Metathesaurus)
CL Item
Dermatitis Exfoliative Nos (Rash/desquamation)
CL Item
Rigors (Rigors/chills)
C0424790 (NCI Metathesaurus)
CL Item
Vomiting Nos (Vomiting)
CL Item
Cough (Cough)
C37935 (NCI Thesaurus)
C0010200 (UMLS 2011AA)
CL Item
Dyspnoea Nos (Dyspnea (shortness of breath))
CL Item
Extremity-lower (gait/walking) (Extremity-lower (gait/walking))
CL Item
Muscle Weakness Nos (Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized)
C0151786 (NCI Metathesaurus)
CL Item
Osteonecrosis (Osteonecrosis (avascular necrosis))
CL Item
Osteoporosis (Osteoporosis)
C3298 (NCI Thesaurus)
C0029456 (UMLS 2011AA)
CL Item
Confusion (Confusion)
C37928 (NCI Thesaurus)
C0009676 (UMLS 2011AA)
CL Item
Dizziness (exc Vertigo) (Dizziness)
CL Item
Anxiety Nec (Mood alteration - anxiety)
CL Item
Depression Nec (Mood alteration - depression)
CL Item
Euphoric Mood (Mood alteration - euphoria)
C27011 (NCI Thesaurus)
C0235146 (UMLS 2011AA)
CL Item
Peripheral Motor Neuropathy (Neuropathy: motor)
C3500 (NCI Thesaurus)
C0018995 (UMLS 2011AA)
CL Item
Peripheral Sensory Neuropathy (Neuropathy: sensory)
C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)
CL Item
Delusion Nos (Psychosis (hallucinations/delusions))
CL Item
Convulsions Nos (Seizure)
CL Item
Depressed Level Of Consciousness (Somnolence/depressed level of consciousness)
C0549249 (NCI Metathesaurus)
CL Item
Syncope (Syncope (fainting))
C35053 (NCI Thesaurus)
C0039070 (UMLS 2011AA)
CL Item
Tremor Nec (Tremor)
CL Item
Dry Eye Nec (Dry eye syndrome)
CL Item
Diplopia (Ophthalmoplegia/diplopia (double vision))
C37941 (NCI Thesaurus)
C0012569 (UMLS 2011AA)
CL Item
Vision Blurred (Vision-blurred vision)
CL Item
Nasal Cavity/paranasal Sinus Reactions (Nasal cavity/paranasal sinus reactions)
CL Item
Pleural Effusion (Pleural effusion (non-malignant))
C3331 (NCI Thesaurus)
C0021071 (UMLS 2011AA)
CL Item
Sexual/reproductive Function Other (Sexual/Reproductive Function-Other (Specify))
CL Item
Peripheral Ischaemia Nos (Peripheral arterial ischemia)
CL Item
Thrombosis/embolism (vascular Access-related) (Thrombosis/embolism (vascular access-related))
CommonToxicityCriteriaAdverseEventGrade
Item
CTC AE Grade (3.0 1-5)
float
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
CTC Adverse Event Attribution Code (* Attribution codes: 1-unrelated 2-unlikely 3-possible 4-probably 5-definite)
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
CL.5
Code List
CTC Adverse Event Attribution Code (* Attribution codes: 1-unrelated 2-unlikely 3-possible 4-probably 5-definite)
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)
CTCAdverseEventTermSpecify
Item
CTC Adverse Event Term Other (specify using CTCAE 3.0 terminology)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA 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)
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