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 @ 4:02 PM
Ignite Modification Date: 2025-12-25 @ 2:04 PM
NCT ID: NCT00855166
Description: Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
Frequency Threshold: 5
Time Frame: Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period if earlier.
Study: NCT00855166
Study Brief: Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight 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 Plus Metformin Placebo oral once daily plus metformin over 24 weeks None None 1 91 9 91 View
Dapagliflozin Plus Metformin Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks None None 6 91 7 91 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Ulcerative keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Transient ischemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.0 View
Oesophageal varices hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View