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 @ 1:18 PM
Ignite Modification Date: 2025-12-25 @ 12:25 PM
NCT ID: NCT00976495
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 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Study: NCT00976495
Study Brief: Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Tablet, oral, once daily for 12 weeks None None 0 25 2 25 View
Dapagliflozin 10 mg Tablet, oral, once daily for 12 weeks None None 3 24 6 24 View
Hydrochlorothiazide 25 mg Tablet, oral, once daily for 12 weeks None None 0 26 9 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
LOCALISED INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version: 13.1 View
INTERVERTEBRAL DISC INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version: 13.1 View
PLEURITIC PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version: 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
POLLAKIURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version: 13.1 View
NOCTURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version: 13.1 View
HYPERHIDROSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version: 13.1 View
INGROWING NAIL SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version: 13.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version: 13.1 View
MALAISE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version: 13.1 View