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 @ 6:47 PM
Ignite Modification Date: 2025-12-25 @ 4:18 PM
NCT ID: NCT04889157
Description: None
Frequency Threshold: 5
Time Frame: Baseline up to 35 days after last dose (Day 91)
Study: NCT04889157
Study Brief: A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus
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 Participants received placebo BID (except QD in the morning on Day 1) from Days 1-56. 0 None 0 5 5 5 View
PF-06882961 BID Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56. 0 None 0 15 14 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v24.1 View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v24.1 View
Photophobia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v24.1 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Regurgitation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Blood uric acid increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Hepatic enzyme increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Sleep deficit NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.1 View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v24.1 View