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 @ 9:45 PM
Ignite Modification Date: 2025-12-25 @ 7:25 PM
NCT ID: NCT05064332
Description: MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an 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: From the first dose up to 35 days after the last dose of study intervention.
Study: NCT05064332
Study Brief: A Study To Estimate The Effect of PF-06650833 On The Pharmacokinetics (PK) of Oral Contraceptive (OC)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Period 1: Oral Contraceptive Participants received a single oral dose of OC, containing EE 30 mcg and LN 150 mcg on Day 1 Period 1. 0 None 0 10 0 10 View
Period 2: PF-06650833 Participants orally received PF-06650833 400 mg QD on Days 1-10 of Period 2. 0 None 0 10 2 10 View
Period 2: PF-06650833 + Oral Contraceptive Participants received a single oral dose of OC, containing of EE 30 mcg and LN 150 mcg on Day 10 Period 2 and a single oral dose of PF-06650833 400 mg on Day 11 Period 2. 0 None 0 10 1 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.1 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.1 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 24.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 24.1 View