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 @ 2:19 PM
Ignite Modification Date: 2025-12-25 @ 12:56 PM
NCT ID: NCT02228395
Description: None
Frequency Threshold: 0
Time Frame: Baseline up to 28 days after last study drug administration.
Study: NCT02228395
Study Brief: Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-04958242 In Healthy Volunteers
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-04958242 0.35 mg All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods. None None 0 6 4 6 View
Placebo All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods. None None 0 9 4 9 View
PF-04958242 0.6 mg All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods. None None 0 6 4 6 View
PF-04958242 0.8 mg All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods. None None 0 6 2 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sinus bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 17.1 View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 17.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Faeces hard NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.1 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.1 View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.1 View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.1 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.1 View
Dizziness postural NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Penis disorder NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 17.1 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.1 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.1 View
Skin lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.1 View