Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 2:43 AM
Ignite Modification Date: 2025-12-26 @ 1:22 AM
NCT ID: NCT00829933
Description: None
Frequency Threshold: 3
Time Frame: None
Study: NCT00829933
Study Brief: Late Phase 2 Study of DU-176b in Patients With Non-Valvular Atrial Fibrillation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DU-176b Low Dose 30mg DU-176b tablets taken once daily for 12 weeks None None 4 130 85 130 View
DU-176b Intermediate Dose 45mg DU-176b tablets taken once daily for 12 weeks None None 2 134 103 134 View
Warfarin Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose None None 7 125 88 125 View
DU-176b High Dose 60mg DU-176b tablets taken once daily for 12 weeks None None 2 130 103 130 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J V.11.0 View
metastases to spine SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J V.11.0 View
cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J V.11.0 View
cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J V.11.0 View
transient ischemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J V.11.0 View
atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J V.11.0 View
cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J V.11.0 View
cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J V.11.0 View
interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA/J V.11.0 View
upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J V.11.0 View
haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA/J V.11.0 View
nephrotic syndrome SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA/J V.11.0 View
benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA/J V.11.0 View
sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA/J V.11.0 View
tooth fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA/J V.11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J V.11.0 View
epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA/J V.11.0 View
Haemorrhage subcutaneous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA/J V.11.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA/J V.11.0 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA/J V.11.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA/J V.11.0 View
glucose urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA/J V.11.0 View
glood urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA/J V.11.0 View
protein urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA/J V.11.0 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA/J V.11.0 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J V.11.0 View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J V.11.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA/J V.11.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA/J V.11.0 View
Eosinophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA/J V.11.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA/J V.11.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA/J V.11.0 View