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 @ 1:06 AM
Ignite Modification Date: 2025-12-25 @ 11:18 PM
NCT ID: NCT04839393
Description: None
Frequency Threshold: 5
Time Frame: Up to 68 days for Part A and up to 173 days for Part B.
Study: NCT04839393
Study Brief: A Drug-Drug Interaction Study Between PF-06882961 and PF-06865571 in Healthy Adult Participants and Overweight Adults or Adults With Obesity Who Are Otherwise Healthy
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-06882961 20 mg Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to. 0 None 0 8 0 8 View
PF-06882961 20 mg + PF-06865571 300 mg In Part A, participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to. 0 None 0 8 0 8 View
PF-06865571 300 mg Participants received a single dose of PF-06865571 300 mg on Day 1 in Part B Period 1 (Days 1-2). 0 None 0 19 1 19 View
PF-06882961 Titration up to 200 mg BID Participants received PF-06882961 titrated up to 200 mg BID in Part B Period 2 (Days 3-46). 0 None 0 19 18 19 View
PF-06865571 300 mg + PF-06882961 200 mg BID Participants received PF-06865571 300 mg single dose on Day 47 and PF-06882961 200 mg BID in Period 3 (Days 47-48). 0 None 0 16 6 16 View
PF-06865571 300 mg BID + PF-06882961 200 mg BID Participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID in on Days 49-61 in Period 4. 0 None 0 16 10 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
SARS-CoV-2 test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Abdominal pain 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
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General 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
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Lethargy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View