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 @ 1:22 AM
Ignite Modification Date: 2025-12-25 @ 11:31 PM
NCT ID: NCT04628793
Description: SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
Frequency Threshold: 5
Time Frame: From first dose of study intervention (Day 1) to telephone Follow Up (28-35 days after lase dose of study intervention) (approximately up to 20 weeks)
Study: NCT04628793
Study Brief: A Study of Single Ascending Doses of PF-07258669 in Healthy Adult 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-07258669 3mg Participants in Cohort 1 who received PF-07258669 3mg 0 None 0 6 2 6 View
PF-07258669 10mg Participants in Cohort 2 who received PF-07258669 10mg 0 None 0 6 1 6 View
PF-07258669 30mg Participants in Cohort 2 who received PF-07258669 30mg 0 None 0 5 2 5 View
PF-07258669 100mg Participants in Cohort 2 who received PF-07258669 100mg 0 None 0 6 3 6 View
PF-07258669 200mg Participants in Cohort 2 who received PF-07258669 200mg 0 None 0 6 1 6 View
PF-07258669 300mg Participants in Cohort 3 who received PF-07258669 300mg 0 None 0 6 2 6 View
PF-07258669 1mg Participants in Cohort 1 who received PF-07258669 1mg 0 None 0 6 1 6 View
PF-07258669 0.3mg Participants in Cohort 1 who received PF-07258669 0.3mg 0 None 0 5 0 5 View
Pooled Placebo All participants who received placebo in any period of any cohort 0 None 0 18 6 18 View
PF-07258669 0.1mg Participants in Cohort 1 who received PF-07258669 0.1mg 0 None 0 5 0 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrioventricular block first degree NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v24.0 View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v24.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.0 View
Noninfective gingivitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.0 View
Vaccination complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.0 View
Blood triglycerides increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.0 View
SARS-CoV-2 test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.0 View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.0 View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.0 View
Orthostatic hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v24.0 View