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 @ 3:04 AM
Ignite Modification Date: 2025-12-26 @ 1:43 AM
NCT ID: NCT02292433
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02292433
Study Brief: A Phase 1 Study In Japanese Subjects With Type 2 Diabetes Mellitus As Monotherapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PF--04937319 100 mg All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period. None None 0 12 1 12 View
PF--04937319 250 mg All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period. None None 0 12 6 12 View
Placebo All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period. None None 0 12 1 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Blood uric acid increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.1 View
Haemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.1 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.1 View