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 @ 9:19 PM
Ignite Modification Date: 2025-12-25 @ 7:06 PM
NCT ID: NCT01272804
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01272804
Study Brief: Multiple Dose Study Of PF-04937319 In Patients 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
PF-04937319 10 mg Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days. None None 0 9 6 9 View
PF-04937319 50 mg Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days. None None 0 9 0 9 View
PF-04937319 300 mg Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days. None None 0 9 8 9 View
Placebo Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days. None None 0 16 5 16 View
PF-04937319 30 mg Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days. None None 0 9 5 9 View
PF-04937319 100 mg Participants received PF-04937319 100 mg tablet orally once daily for 14 days. None None 0 9 3 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 14.0 View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.0 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Acute sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Infected sebaceous cyst NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Blood glucose decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Micturition urgency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Skin disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Skin irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View