MedDRA AE Code (CTCAE v4.0) (Code used to identify the adverse event using a standard mechanism that facilitates analysis. CTEP's code list and associated Category/Term is currently a standard.)
AE Attribution (This question is not asked for baseline assessments. Question should be asked mandatory for all studies that involve drug therapy.)
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
Reporting Period End Date (End of the assessment period.)
Description
AdverseEventFinalAssessmentDate
Data type
date
Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25217
UMLS 2011AA Property
C1516048
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property-2
C25508
UMLS 2011AA Property-2
C0205088
Were adverse events assessed during most recent period (Indicator to clarify whether any AEs were identified during the - reporting period. This is confirmation that the remainder of the form was intentionally left blank.)
Description
AdverseEventMostRecentAssessmentInd-3
Data type
text
Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
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
Expected? (Yes/No)
Description
AdverseEventExpectedIndicator
Data type
boolean
Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25501
UMLS 2011AA Property
C1517001
Serious? (If a 'yes' response is entered, complete the SAE section for - this AE.)
Description
SeriousAdverseEventIndicator
Data type
boolean
Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Metathesaurus Property
CL124429
Event Onset Time (Enter the time of day when AE was first evident. Used when Date of Onset is insufficient.)
Description
AdverseEventOnsetTime
Data type
time
Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ValueDomain
C25207
UMLS 2011AA ValueDomain
C0040223
NCI Thesaurus Property
C25279
UMLS 2011AA Property
C0332162
Course (May be used during protocol therapy period to automatically - set the evaluation start/end dates to the period of the course of treatment e.g. user supplies course# and evaluation period derived.)
Description
ProtocolCourseNumberCount
Data type
float
Alias
NCI Thesaurus Property
C25337
UMLS 2011AA Property
C0237753
NCI Thesaurus ObjectClass
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass-2
C25379
UMLS 2011AA ObjectClass-2
C0750729
AE Evaluation Period Start Date (Date of the beginning start of the assessment period.)
Description
AdverseEventBeginAssessmentDate
Data type
date
Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property-2
C25431
UMLS 2011AA Property
C0439659
Pre-existing AE? (Should be derivable if you capture AEs for specified periods; not needed if you track an AE until it resolves including worseningrather than for a defined assessment period.)
Description
AdverseEventPre-ExistingIndicator
Data type
boolean
Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C73621
UMLS 2011AA Property
C2347662
AE Resolved Time (Enter the time of day when AE was resolved.)
Description
AdverseEventResolutionTime
Data type
time
Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ValueDomain
C25207
UMLS 2011AA ValueDomain
C0040223
NCI Thesaurus Property
C25655
UMLS 2011AA Property
C1514893
AE Ongoing? (Flag to indicate whether AE has resolved or not. This ensures that leaving 'Stop Date' blank was not done inadvertently.)
Description
AdverseEventOngoingEventIndicator
Data type
boolean
Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25499
UMLS 2011AA Property
C0441471
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Metathesaurus Property
CL259742
Participant Status/Outcome
Description
AdverseEventOutcomeType
Data type
text
Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain-2
C49489
UMLS 2011AA ValueDomain-2
C1705586
Adverse Event Condition Pattern (This should be derivable from a review of AEs over time.)
Description
AdverseEventConditionPattern
Data type
text
Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25457
UMLS 2011AA Property
C0348080
Did event reappear after study agent was reintroduced? (Enter response from choice list.)
Description
AdverseEventReappearanceIndicator
Data type
text
Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Metathesaurus Property
C0034897
NCI Metathesaurus ValueDomain
C0021212
Comments (A general comment that should not be specific to a single AE.)
Adverse Event Term (v4.0) (Code used to identify the adverse event using a standard mechanism that facilitates analysis. CTEP's code list and associated Category/Term is currently a standard.)
Adverse Event Term (v4.0) (Code used to identify the adverse event using a standard mechanism that facilitates analysis. CTEP's code list and associated Category/Term is currently a standard.)
MedDRA AE Code (CTCAE v4.0) (Code used to identify the adverse event using a standard mechanism that facilitates analysis. CTEP's code list and associated Category/Term is currently a standard.)
MedDRA AE Code (CTCAE v4.0) (Code used to identify the adverse event using a standard mechanism that facilitates analysis. CTEP's code list and associated Category/Term is currently a standard.)
CL Item
Abdominal Distension (10000060)
E10456 (CTCAE)
CL Item
Abdominal Pain (10000081)
E10460 (CTCAE)
CL Item
Acidosis (10000486)
E12237 (CTCAE)
CL Item
Acoustic Nerve Disorder Nos (10000521)
E12577 (CTCAE)
CL Item
Activated Partial Thromboplastin Time Prolonged (10000636)
E12073 (CTCAE)
CL Item
Adrenal Insufficiency (10001367)
E10298 (CTCAE)
CL Item
Adult Respiratory Distress Syndrome (10001409)
E13299 (CTCAE)
CL Item
Agitation (10001497)
CL Item
Akathisia (10001540)
CL Item
Alanine Aminotransferase Increased (10001551)
CL Item
Alcohol Intolerance (10001598)
CL Item
Alkaline Phosphatase Increased (10001675)
CL Item
Alkalosis (10001680)
CL Item
Allergic Reaction (10001718)
CL Item
Allergic Rhinitis (10001723)
CL Item
Alopecia (10001760)
CL Item
Amnesia (10001949)
CL Item
Anal Fistula (10002156)
CL Item
Anal Pain (10002167)
CL Item
Anal Stenosis (10002176)
CL Item
Anal Ulcer (10002180)
CL Item
Anaphylaxis (10002218)
CL Item
Anemia (10002272)
CL Item
Ankle Fracture (10002544)
CL Item
Anorexia (10002646)
CL Item
Anorgasmia (10002652)
CL Item
Anxiety (10002855)
CL Item
Aortic Injury (10002899)
CL Item
Aphonia (10002953)
CL Item
Apnea (10002972)
CL Item
Appendicitis (10003011)
CL Item
Appendicitis Perforated (10003012)
CL Item
Arachnoiditis (10003074)
CL Item
Arterial Injury (10003162)
CL Item
Arthralgia (10003239)
CL Item
Arthritis (10003246)
CL Item
Ascites (10003445)
CL Item
Aspartate Aminotransferase Increased (10003481)
CL Item
Aspiration (10003504)
CL Item
Asystole (10003586)
CL Item
Ataxia (10003591)
CL Item
Atelectasis (10003598)
CL Item
Atrial Fibrillation (10003658)
CL Item
Atrial Flutter (10003662)
CL Item
Atrioventricular Block Complete (10003673)
CL Item
Atrioventricular Block First Degree (10003674)
CL Item
Azoospermia (10003883)
CL Item
Back Pain (10003988)
CL Item
Biliary Fistula (10004665)
CL Item
Bladder Infection (10005047)
CL Item
Bloating (10005265)
CL Item
Blood And Lymphatic System Disorders - Other, Specify (10005329)
E10016 (CTCAE)
CL Item
Blood Antidiuretic Hormone Abnormal (10005332)
CL Item
Blood Bilirubin Increased (10005364)
CL Item
Blood Corticotrophin Decreased (10005452)
CL Item
Blood Gonadotrophin Abnormal (10005561)
CL Item
Blood Prolactin Abnormal (10005778)
CL Item
Blurred Vision (10005886)
CL Item
Body Odor (10005901)
CL Item
Bone Pain (10006002)
CL Item
Breast Atrophy (10006179)
CL Item
Breast Infection (10006259)
CL Item
Breast Pain (10006298)
CL Item
Bronchial Fistula (10006437)
CL Item
Bronchial Obstruction (10006440)
CL Item
Bronchospasm (10006482)
CL Item
Bruising (10006504)
CL Item
Bullous Dermatitis (10006556)
CL Item
Burn (10006634)
CL Item
Capillary Leak Syndrome (10007196)
CL Item
Cardiac Arrest (10007515)
CL Item
Cardiac Disorders - Other, Specify (10007541)
E10104 (CTCAE)
CL Item
Cardiac Troponin I Increased (10007612)
CL Item
Cardiac Troponin T Increased (10007613)
CL Item
Cataract (10007739)
CL Item
Catheter Related Infection (10007810)
CL Item
Cd4 Lymphocytes Decreased (10007839)
CL Item
Cerebrospinal Fluid Leakage (10008164)
CL Item
Cervicitis Infection (10008330)
CL Item
Cheilitis (10008417)
CL Item
Chest Pain - Cardiac (10008481)
CL Item
Chest Wall Pain (10008496)
CL Item
Chills (10008531)
CL Item
Cholecystitis (10008612)
CL Item
Cholesterol High (10008661)
CL Item
Cognitive Disturbance (10009845)
CL Item
Colitis (10009887)
CL Item
Colonic Fistula (10009995)
CL Item
Colonic Hemorrhage (10009998)
CL Item
Colonic Obstruction (10010000)
CL Item
Colonic Perforation (10010001)
CL Item
Colonic Stenosis (10010004)
CL Item
Colonic Ulcer (10010006)
CL Item
Concentration Impairment (10010250)
CL Item
Conduction Disorder (10010276)
CL Item
Confusion (10010300)
CL Item
Congenital, Familial And Genetic Disorders - Other, Specify (10010331)
E10250 (CTCAE)
CL Item
Conjunctivitis (10010741)
CL Item
Conjunctivitis Infective (10010742)
CL Item
Constipation (10010774)
CL Item
Constrictive Pericarditis (10010783)
CL Item
Cough (10011224)
CL Item
Cpk Increased (10011268)
CL Item
Creatinine Increased (10011368)
CL Item
Cushingoid (10011655)
CL Item
Death Neonatal (10011912)
CL Item
Death Nos (10011914)
CL Item
Dehydration (10012174)
CL Item
Delayed Puberty (10012205)
CL Item
Delirium (10012218)
CL Item
Delusions (10012260)
CL Item
Dental Caries (10012318)
CL Item
Depressed Level Of Consciousness (10012373)
CL Item
Depression (10012378)
CL Item
Diarrhea (10012727)
CL Item
Disseminated Intravascular Coagulation (10013442)
CL Item
Dizziness (10013573)
CL Item
Dry Eye (10013774)
CL Item
Dry Mouth (10013781)
CL Item
Dry Skin (10013786)
CL Item
Duodenal Fistula (10013828)
CL Item
Duodenal Obstruction (10013830)
CL Item
Duodenal Perforation (10013832)
CL Item
Duodenal Ulcer (10013836)
CL Item
Dysarthria (10013887)
CL Item
Dysgeusia (10013911)
CL Item
Dysmenorrhea (10013934)
CL Item
Dyspareunia (10013941)
CL Item
Dyspepsia (10013946)
CL Item
Dysphagia (10013950)
CL Item
Dysphasia (10013951)
CL Item
Dyspnea (10013963)
CL Item
Ear And Labyrinth Disorders - Other, Specify (10013993)
Were adverse events assessed during most recent period (Indicator to clarify whether any AEs were identified during the - reporting period. This is confirmation that the remainder of the form was intentionally left blank.)
Were adverse events assessed during most recent period (Indicator to clarify whether any AEs were identified during the - reporting period. This is confirmation that the remainder of the form was intentionally left blank.)
Course (May be used during protocol therapy period to automatically - set the evaluation start/end dates to the period of the course of treatment e.g. user supplies course# and evaluation period derived.)
Pre-existing AE? (Should be derivable if you capture AEs for specified periods; not needed if you track an AE until it resolves including worseningrather than for a defined assessment period.)
Requires Inpatient Hospitalization Or Prolongation Of Existing Hospitalization (3)
CL Item
Results In Persistent Or Significant Disability/incapacity (4)
CL Item
Is A Congenital Anomaly/birth Defect (5)
CL Item
In The Medical Judgment Of The Treating Physician And/or Investigator, It May Jeopardize The Participant Or Require Intervention To Prevent One Of These Outcomes (6)
CL Item
Other, Specify (7)
CL Item
Meets Criteria Per Protocol But Does Not Meet Other Criterion (above) (8)