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 @ 4:54 PM
Ignite Modification Date: 2025-12-25 @ 2:37 PM
NCT ID: NCT05660850
Description: Safety population included all randomized participants who received at least one dose of study drug. treatment. As prespecifid in the protocol participants in Parts A and B were grouped according to the treatment received to compare results between GDC-6599 \& placebo regardless of treatment period \& disease cohort.
Frequency Threshold: 5
Time Frame: From signing of ICF until 28 days after the final dose of study drug (up to approximately 16 weeks)
Study: NCT05660850
Study Brief: A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants received GDC-6599 matching placebo tablets, orally, BID for 14 days in Period 1 or Period 2. 0 None 0 49 2 49 View
Safety Follow-up Participants were assessed for an additional 28 days for safety after receiving the last dose of study treatment or treatment discontinuation visit. 0 None 0 49 0 49 View
GDC-6599 Participants received GDC-6599, 50 mg tablets, orally, BID for 14 days in Period 1 or Period 2. 0 None 0 49 5 49 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 27.1 View