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 @ 2:22 PM
Ignite Modification Date: 2025-12-25 @ 12:59 PM
NCT ID: NCT01854359
Description: Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT01854359
Study Brief: Idebenone for Primary Progressive Multiple Sclerosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Treatment in 09-I-0197 Idebenone (150mg tablets) administered orally as five tablets, three times per day with food. Two years of Idebenone treatment during the 09-I-0197 double-blind phase 0 None 4 31 10 31 View
Placebo in 09-I-0197 Idebenone (150mg tablets) administered orally as five tablets, three times per day with food. Two years of placebo during the 09-I-0197 double-blind phase 0 None 4 30 14 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
decreased ejection fraction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
stomach cancer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
severe constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
gallstones SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
ruptured apendix SYSTEMATIC_ASSESSMENT Infections and infestations None View
broken ribs SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
broken femur SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
chest tightness SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Elevated liver enzynes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
basal cell carcinoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
benign thyroid nodule SYSTEMATIC_ASSESSMENT Endocrine disorders None View
chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
fractured bone SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
H1N1 influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
hair loss SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
increased mobility problems SYSTEMATIC_ASSESSMENT General disorders None View
injured meniscus SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
penumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders None View
skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
transient graying of vision SYSTEMATIC_ASSESSMENT Eye disorders None View
urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
edema SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
radiculopathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View