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 @ 1:59 PM
Ignite Modification Date: 2025-12-25 @ 12:45 PM
NCT ID: NCT05799495
Description: Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Frequency Threshold: 5
Time Frame: From start of study intervention up to 28 days after last dose of study intervention (up to 33 days).
Study: NCT05799495
Study Brief: A Study to Understand the Effect and Safety of the Study Medicine PF-07817883 in Adults Who Have Symptoms of COVID-19 But Are Not Hospitalized
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-07817883 100mg Participants received PF-07817883, 100 mg orally q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. 0 None 0 40 0 40 View
PF-07817883 300mg Participants received PF-07817883, 300 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. 0 None 1 39 1 39 View
PF-07817883 600mg Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. 0 None 0 79 2 79 View
Placebo Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. 0 None 0 79 4 79 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Supraventricular extrasystoles NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.1 View