Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:58 PM
Ignite Modification Date: 2025-12-25 @ 12:18 PM
NCT ID: NCT01396161
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 0
Time Frame: None
Study: NCT01396161
Study Brief: A Study of PF-05175157 in Healthy Volunteers and Type 2 Diabetic Patients
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-05175157 30 mg QD - HOV HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days None None 0 9 1 9 View
PF-05175157 100 mg QD - HOV HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days None None 0 9 1 9 View
PF-05175157 200 mg QD - T2DM T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days None None 0 11 3 11 View
Placebo - HOV HOV participants administered orally matched placebo capsules QD for 14 days None None 0 12 2 12 View
Placebo - T2DM T2DM participants administered orally matched placebo capsules QD for 14 days None None 0 5 2 5 View
PF-05175157 200 mg QD - HOV HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days None None 0 9 2 9 View
PF-05175157 100 mg BID - HOV HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days None None 0 9 5 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders 14.0 View
Conjunctival irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders 14.0 View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders 14.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.0 View
Rectal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations 14.0 View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 14.0 View
Plantar fasciitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 14.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders 14.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders 14.0 View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 14.0 View