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  1. StudyEvent: Adverse Events - CTCAE v3.0
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Birth Date
Item
Patient Birth Date
date
C25164 (NCI Thesaurus ValueDomain)
C0421451 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)
Patient Hospital No
Item
Patient Hospital Number
text
C25337 (NCI Thesaurus ValueDomain)
C0421459 (UMLS CUI-1)
C16960 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C16696 (NCI Thesaurus ObjectClass)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Institution Number
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Investigator Name
Item
Physician of Record
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
Investigator Signature Date
Item
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)
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Item Group
Clinical Tolerance: CTCAE (version 3.0)
C1516728 (UMLS CUI-1)
Item
Time
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
CL.1
Code List
Time
CL Item
Cycle 2 (Cycle 2)
CL Item
Cycle 3 (Cycle 3)
CL Item
Cycle 4 (Cycle 4)
CL Item
Cycle 5 (Cycle 5)
CL Item
Cycle 6 (Cycle 6)
CL Item
Cycle 7 (Cycle 7)
CL Item
Cycle 8 (Cycle 8)
Assessment Date
Item
Date of Assessment
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Adverse event
Item
Were adverse events assessed during most recent period
boolean
C38148 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus Property)
C41331 (NCI Thesaurus ObjectClass)
C25577 (NCI Thesaurus Property-2)
C0877248 (UMLS CUI-1)
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
Allergy/immunology Other (Allergy/Immunology-Other (Specify))
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
Myocardial Ischaemia (Cardiac ischemia/infarction)
C0151744 (NCI Metathesaurus)
CL Item
Hypertension Nos (Hypertension)
CL Item
Hypotension Nos (Hypotension)
CL Item
Left Ventricular Failure (Left ventricular systolic dysfunction)
C0023212 (NCI Metathesaurus)
CL Item
Cardiac General Other (Cardiac General-Other (Specify))
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
Sweating Increased (Sweating (diaphoresis))
C0700590 (NCI Metathesaurus)
CL Item
Constitutional Symptoms Other (Constitutional Symptoms-Other (Specify))
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
Localised Exfoliation (Rash: hand-foot skin reaction)
CL Item
Dermatology/skin Other (Dermatology/Skin-Other (Specify))
CL Item
Menopausal Symptoms (Hot flashes/flushes)
CL Item
Endocrine Other (Endocrine-Other (Specify))
CL Item
Constipation (Constipation)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Diarrhoea Nos (Diarrhea)
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Vomiting Nos (Vomiting)
CL Item
Gastrointestinal Other (Gastrointestinal-Other (Specify))
CL Item
Vaginal Haemorrhage (Hemorrhage, GU - Vagina)
CL Item
Hemorrhage/bleeding Other (Hemorrhage/Bleeding-Other (Specify))
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
Infection Nos (Infection-Other (Specify))
CL Item
Hypercholesteraemia (Cholesterol, serum-high (hypercholesteremia))
CL Item
Metabolic/laboratory Other (Metabolic/Laboratory-Other (Specify))
CL Item
Fracture (Fracture)
C3046 (NCI Thesaurus)
C0016658 (UMLS 2011AA)
CL Item
Osteoporosis (Osteoporosis)
C3298 (NCI Thesaurus)
C0029456 (UMLS 2011AA)
CL Item
Musculoskeletal/soft Tissue Other (Musculoskeletal/Soft Tissue-Other (Specify))
CL Item
Cerebral Ischaemia (CNS cerebrovascular ischemia)
C0917798 (NCI Metathesaurus)
CL Item
Dizziness (exc Vertigo) (Dizziness)
CL Item
Mood Alteration - Agitation (Mood alteration - agitation)
CL Item
Anxiety Nec (Mood alteration - anxiety)
CL Item
Depression Nec (Mood alteration - depression)
CL Item
Peripheral Sensory Neuropathy (Neuropathy: sensory)
C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)
CL Item
Neurology Other (Neurology-Other (Specify))
CL Item
Bone Pain (Pain - Bone)
C38644 (NCI Thesaurus)
C0151825 (UMLS 2011AA)
CL Item
Arthralgia (Pain - Joint)
C0003862 (NCI Metathesaurus)
CL Item
Myalgia (Pain - Muscle)
C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)
CL Item
Pain Other (Pain-Other (Specify))
CL Item
Cough (Cough)
C37935 (NCI Thesaurus)
C0010200 (UMLS 2011AA)
CL Item
Dyspnoea Nos (Dyspnea (shortness of breath))
CL Item
Pleural Effusion (Pleural effusion (non-malignant))
C3331 (NCI Thesaurus)
C0021071 (UMLS 2011AA)
CL Item
Renal/genitourinary Other (Renal/Genitourinary-Other (Specify))
CL Item
Menstruation Irregular (Irregular menses (change from baseline))
CL Item
Sexual/reproductive Function Other (Sexual/Reproductive Function-Other (Specify))
CL Item
Thrombosis/embolism (vascular Access-related) (Thrombosis/embolism (vascular access-related))
CL Item
Oedema Nos (Edema: limb)
CTC Adverse Event Grade
Item
CTC AE Grade
integer
C49704 (NCI Thesaurus ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
C2985911 (UMLS CUI-1)
CTCAE v3.0 Short Name
Item
CTCAE v3.0 Short Name
text
C25364 (NCI Thesaurus Property)
C49704 (NCI Thesaurus ObjectClass)
C0332307 (NCI Metathesaurus ValueDomain)
C25249 (NCI Thesaurus Property-2)
C1516728 (UMLS CUI-1)
C1806781 (UMLS CUI-2)
CTC Adverse Event Allergy/Immunology
Item
CTC Adverse Event Allergy/Immunology-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C17649 (NCI Thesaurus Property)
C3114 (NCI Thesaurus Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS CUI-1)
C0020517 (UMLS CUI-2)
CTC Adverse Event Cardiac General
Item
CTC Adverse Event Cardiac General-Other
text
C25685 (NCI Thesaurus ValueDomain)
C17649 (NCI Thesaurus Property)
C25292 (NCI Thesaurus Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS CUI-1)
C0007226 (UMLS CUI-2)
CTC Adverse Event Constitutional Symptoms
Item
CTC Adverse Event Constitutional Symptoms-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C17649 (NCI Thesaurus Property)
C49704 (NCI Thesaurus ObjectClass)
C0009812 (NCI Metathesaurus Property)
C1516728 (UMLS CUI-1)
C0009812 (UMLS CUI-2)
CTC Adverse Event Dermatology/Skin
Item
CTC Adverse Event Dermatology/Skin-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C17649 (NCI Thesaurus Property)
C12470 (NCI Thesaurus Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS CUI-1)
C1123023 (UMLS CUI-2)
CTC Adverse Event Endocrine
Item
CTC Adverse Event Endocrine-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C17649 (NCI Thesaurus Property)
C49704 (NCI Thesaurus ObjectClass)
C0014136 (NCI Metathesaurus Property)
C1516728 (UMLS CUI-1)
C0014136 (UMLS CUI-2)
CTC Adverse Event Gastrointestinal
Item
CTC Adverse Event Gastrointestinal-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C17649 (NCI Thesaurus Property)
C49704 (NCI Thesaurus ObjectClass)
C0426576 (NCI Metathesaurus Property)
C1516728 (UMLS CUI-1)
C0521362 (UMLS CUI-2)
CTC Adverse Event Hemorrhage/Bleeding
Item
CTC Adverse Event Hemorrhage/Bleeding-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C17649 (NCI Thesaurus Property)
C26791 (NCI Thesaurus Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS CUI-1)
C0019080 (UMLS CUI-2)
CTC Adverse Event Infection
Item
CTC Adverse Event Infection-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C17649 (NCI Thesaurus Property)
C26726 (NCI Thesaurus Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS CUI-1)
C3714514 (UMLS CUI-2)
CTC Adverse Event Metabolic/Laboratory
Item
CTC Adverse Event Metabolic/Laboratory-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C17649 (NCI Thesaurus Property)
C37984 (NCI Thesaurus Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS CUI-1)
C0022877 (UMLS CUI-2)
CTC Adverse Event Musculoskeletal/Soft Tissue
Item
CTC Adverse Event Musculoskeletal/Soft Tissue-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C17649 (NCI Thesaurus Property)
C25348 (NCI Thesaurus Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS CUI-1)
C0497254 (UMLS CUI-2)
CTC Adverse Event Neurology
Item
CTC Adverse Event Neurology-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C17649 (NCI Thesaurus Property)
C25262 (NCI Thesaurus Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS CUI-1)
C0205494 (UMLS CUI-2)
CTC Adverse Event Pain
Item
CTC Adverse Event Pain-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C17649 (NCI Thesaurus Property)
C3303 (NCI Thesaurus Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS CUI-1)
C0030193 (UMLS CUI-2)
CTC Adverse Event Pulmonary/Upper Respiratory
Item
CTC Adverse Event Pulmonary/Upper Respiratory-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C17649 (NCI Thesaurus Property)
C49704 (NCI Thesaurus ObjectClass)
CL317978 (NCI Metathesaurus Property)
C1516728 (UMLS CUI-1)
C1557628 (UMLS CUI-2)
CTC Adverse Event Renal/Genitourinary
Item
CTC Adverse Event Renal/Genitourinary-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C17649 (NCI Thesaurus Property)
C25350 (NCI Thesaurus Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS CUI-1)
C1558061 (UMLS CUI-2)
CTC Adverse Event Sexual/Reproductive Function
Item
CTC Adverse Event Sexual/Reproductive Function-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C17649 (NCI Thesaurus Property)
C49704 (NCI Thesaurus ObjectClass)
C0232896 (NCI Metathesaurus Property)
C1516728 (UMLS CUI-1)
C1558153 (UMLS CUI-2)
CTC Adverse Event Vascular
Item
CTC Adverse Event Vascular-Other (Specify)
text
C25685 (NCI Thesaurus ValueDomain)
C17649 (NCI Thesaurus Property)
C13311 (NCI Thesaurus Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS CUI-1)
C1801960 (UMLS CUI-2)
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