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 @ 6:38 PM
Ignite Modification Date: 2025-12-25 @ 4:08 PM
NCT ID: NCT01401257
Description: None
Frequency Threshold: 2
Time Frame: 13 months
Study: NCT01401257
Study Brief: Phase II, Randomized, Placebo-controlled Trial in Patients With Charcot-marie-tooth Disease Type 1A
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PXT3003 Low Dose Oral Liquid formulation, 1/100, bid, 12 months PXT3003: Liquid,5 ml, twice a day, 12-month treatment None None 2 21 12 21 View
PXT3003 Intermediate Dose Oral Liquid formulation, 1/50, bid, 12 months PXT3003: Liquid,5 ml, twice a day, 12-month treatment None None 0 21 10 21 View
PXT3003 High Dose Oral Liquid formulation, 1/10, bid, 12 months PXT3003: Liquid,5 ml, twice a day, 12-month treatment None None 0 19 13 19 View
Placebo Oral Liquid formulation, bid, 12 months Placebo: Liquid,5 ml, twice a day, 12-month treatment None None 0 19 11 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Musculoskeletal and connective tissue disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Nervous system disorders SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View