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 @ 2:20 AM
Ignite Modification Date: 2025-12-26 @ 12:52 AM
NCT ID: NCT05339334
Description: The adverse events were reported by the treatment group of PF-07321332 300 mg + Ritonavir 100 mg, instead of by 2 treatment groups separately as PF-07321332 and ritonavir were dosed simultaneously (within no more than 5 minutes of each other).
Frequency Threshold: 0
Time Frame: From baseline up to Day 42.
Study: NCT05339334
Study Brief: A Study to Learn About the Study Medicine PF-07321332 and Ritonavir in Adult Healthy Chinese 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
PF-07321332 300 mg + Ritonavir 100 mg The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10). 0 None 0 14 6 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25.0 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View