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 @ 7:24 PM
Ignite Modification Date: 2025-12-25 @ 5:04 PM
NCT ID: NCT04644003
Description: As per ClinicalTrials.gov definitions.
Frequency Threshold: 0
Time Frame: The total duration of the study for each participant was up to six weeks divided as follows: a screening phase of two weeks (from Day -14 to Day -1); a double-blind treatment phase of two weeks (from Day 1 to Day 14); and a follow-up phase of two weeks after treatment discontinuation (from Day 15 to Day 28).
Study: NCT04644003
Study Brief: Safety, Tolerability and Pharmacokinetics Study of STP1 in a Subgroup of Patients With Autism Spectrum Disorder (ASD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
STP1 Low Dose 1 capsule and 1 tablet per intake STP1: STP1 is a combination of two drugs, a PDE inhibitor and an NKCC1 inhibitor 0 None 0 6 5 6 View
STP1 High Dose 1 capsule and 1 tablet per intake STP1: STP1 is a combination of two drugs, a PDE inhibitor and an NKCC1 inhibitor 0 None 0 3 2 3 View
Placebo 1 placebo capsule and 1 placebo tablet per intake Placebo: Placebo medication (capsule and tablet) identical in appearance to active medication 0 None 0 3 2 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Trichotillomania SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View