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 @ 11:49 PM
Ignite Modification Date: 2025-12-25 @ 9:43 PM
NCT ID: NCT02998151
Description: Participants were asked about adverse events in person 4 hours after each dose and at the end of each dosing visit, and via phone calls conducted one day after and 8 days after each dosing visit. Additionally, participants were contacted by phone 4 weeks after the final dosing visit.
Frequency Threshold: 5
Time Frame: Adverse events were collected up to four weeks after the final dosing visit.
Study: NCT02998151
Study Brief: Neurophysiological and Acute Pharmacological Studies in FXS Patients
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 Placebo: placebo pill 0 None 0 27 3 27 View
Acamprosate Acamprosate: two 666mg pills 0 None 0 16 7 16 View
Lovastatin Lovastatin: two 20mg pills 0 None 0 29 4 29 View
Minocycline Minocycline: two 135mg pills 0 None 0 27 4 27 View
Baclofen Baclofen: one 30mg pill 0 None 0 18 4 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v5.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v5.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v5.0 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v5.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v5.0 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v5.0 View
Mania SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v5.0 View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v5.0 View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v5.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v5.0 View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v5.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v5.0 View