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 @ 4:42 PM
Ignite Modification Date: 2025-12-25 @ 2:30 PM
NCT ID: NCT01095666
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: NCT01095666
Study Brief: A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
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 + Metformin None None None 6 145 34 145 View
Dapagliflozin 5 mg + Metformin None None None 3 147 43 147 View
Dapagliflozin 10 mg + Metformin None None None 3 152 42 152 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
BENIGN PROSTATIC HYPERPLASIA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA Version: 16.0 View
ASTHMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version: 16.0 View
ANKLE FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version: 16.0 View
LOWER LIMB FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version: 16.0 View
JOINT INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version: 16.0 View
UTERINE LEIOMYOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version: 16.0 View
INFLAMMATORY PSEUDOTUMOUR SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version: 16.0 View
SQUAMOUS CELL CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version: 16.0 View
LEIOMYOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version: 16.0 View
ANGINA UNSTABLE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version: 16.0 View
MYOCARDIAL BRIDGING SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA Version: 16.0 View
ABDOMINAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version: 16.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version: 16.0 View
INTERVERTEBRAL DISC PROTRUSION SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version: 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
HYPERLIPIDAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version: 16.0 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version: 16.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version: 16.0 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version: 16.0 View
HYPERURICAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version: 16.0 View