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 @ 4:55 PM
Ignite Modification Date: 2025-12-25 @ 2:37 PM
NCT ID: NCT05032950
Description: None
Frequency Threshold: 5
Time Frame: Baseline up to Day 28
Study: NCT05032950
Study Brief: Drug-Drug Interaction Study to Estimate the Effect of PF-07321332/Ritonavir and Ritonavir on Midazolam in Healthy Participants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Midazolam 2 mg Midazolam administered as a single dose on Day 1 0 None 0 10 4 10 View
PF-07321332 300 mg/Ritonavir 100 mg + Midazolam 2 mg PF-07321332/ritonavir: Administered orally every 12 hours for a total of 9 doses on Days 1-5 Midazolam: Administered orally as a single dose on Day 5 0 None 0 11 9 11 View
Ritonavir 100 mg + Midazolam 2 mg Ritonavir: Administered orally every 12 hours for a total of 9 doses on Days 1-5 Midazolam: Administered orally as a single dose on Day 5 0 None 0 11 7 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nodal rhythm NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 24.1 View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.1 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.1 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.1 View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.1 View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.1 View
Vessel puncture site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.1 View
Vessel puncture site reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.1 View
Folliculitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 24.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 24.1 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 24.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 24.1 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 24.1 View
Nightmare NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 24.1 View
Heavy menstrual bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version 24.1 View
Vaginal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version 24.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 24.1 View
Dry throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 24.1 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 24.1 View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 24.1 View