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: 2025-12-24 @ 11:51 PM
Ignite Modification Date: 2025-12-25 @ 9:46 PM
NCT ID: NCT00643851
Description: None
Frequency Threshold: 5
Time Frame: Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Study: NCT00643851
Study Brief: An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Metformin XR Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks None None 7 201 40 201 View
Dapagliflozin 5 mg + Metformin XR Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks None None 6 194 48 194 View
Dapagliflozin 5 mg Dapagliflozin tablets, oral, once daily for 24 weeks None None 9 203 32 203 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
PULMONARY TUBERCULOSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version: 12.0 View
HERPES ZOSTER SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version: 12.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version: 12.0 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version: 12.0 View
CYSTITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version: 12.0 View
GANGRENE SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version: 12.0 View
PYELONEPHRITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version: 12.0 View
OESOPHAGITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version: 12.0 View
GASTROINTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version: 12.0 View
GUN SHOT WOUND SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version: 12.0 View
UPPER LIMB FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version: 12.0 View
ACUTE MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version: 12.0 View
ANGINA UNSTABLE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version: 12.0 View
CARDIOPULMONARY FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version: 12.0 View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version: 12.0 View
DIABETES MELLITUS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version: 12.0 View
BREAST CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version: 12.0 View
CEREBROVASCULAR ACCIDENT SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version: 12.0 View
ISCHAEMIC NEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version: 12.0 View
HYPERTENSIVE CRISIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version: 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version: 12.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version: 12.0 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version: 12.0 View
DYSLIPIDAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version: 12.0 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version: 12.0 View