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 @ 3:22 AM
Ignite Modification Date: 2025-12-26 @ 2:00 AM
NCT ID: NCT05890105
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Frequency Threshold: 5
Time Frame: Day 1-11 in each period, along with the 29-36 day post final dose follow-up
Study: NCT05890105
Study Brief: A Study to Learn About the Study Medicine PF-07853578 and How it Acts in the Bodies of Healthy Adults
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-07853578 1 mg (1mg) (Low Dosage Strength [LDS] Solution) Participants in Cohort 1 received 1 mg (LDS Solution). 0 None 0 5 1 5 View
3 mg Participants in Cohort 2 received 3 mg. 0 None 0 6 2 6 View
8 mg Participants in Cohort 3 received 8 mg. 0 None 0 5 3 5 View
8 mg (Intermediate Dosage Strength [IDS] Solution) Participants in Cohort 3 received 8 mg (IDS Solution) 0 None 0 5 2 5 View
10 mg Participants in Cohort 1 received 10 mg. 0 None 0 5 2 5 View
30 mg Participants in Cohort 2 received 30 mg. 0 None 0 6 1 6 View
100 mg Participant in Cohort 1 received 100 mg. 0 None 0 5 0 5 View
300 mg Participants in Cohort 2 received 300 mg. 0 None 0 6 1 6 View
300 mg Fed Participants in Cohort 2 received 300 mg Fed. 0 None 0 5 4 5 View
500 mg Participants in Cohort 1 received 500 mg. 0 None 0 4 0 4 View
Placebo Fasted Participants in Cohorts 1, 2, and 3 received Placebo Fasted. 0 None 0 14 3 14 View
Placebo Fed Participants in Cohort 2 received Placebo Fed. 0 None 0 1 0 1 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypoacusis NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v26.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.1 View
Application site irritation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.1 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.1 View
Tension headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.1 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.1 View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.1 View
Drug eruption NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.1 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.1 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.1 View
Feeling hot NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.1 View
Furuncle NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Road traffic accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.1 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.1 View