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 @ 6:28 PM

Ignite Modification Date: 2025-12-25 @ 3:58 PM

NCT ID: NCT00905268

Description: None

Frequency Threshold: 5

Time Frame: None

Study: NCT00905268

Study Brief: A Study of Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia (FRDA) 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

Group A: Idebenone	Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.	None	None	7	57	55	57	View
Group B: Idebenone	Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.	None	None	4	57	52	57	View
C: Idebenone	Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.	None	None	8	59	52	59	View
D: Placebo	placebo Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.	None	None	7	59	55	59	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Sinusitis	None	Infections and infestations	None	View
gastroenteritis	None	Infections and infestations	None	View
diabetes mellitus	None	Endocrine disorders	None	View
hypertrophic cardiomyopathy	None	Cardiac disorders	None	View
supraventricular tachycardia	None	Cardiac disorders	None	View
Atrial fibrillation	None	Cardiac disorders	None	View
Gastritis	None	Gastrointestinal disorders	None	View
abortion spontaneous	None	Pregnancy, puerperium and perinatal conditions	None	View
inguinal hernia	None	Gastrointestinal disorders	None	View
drug exposure during pregnancy	None	Pregnancy, puerperium and perinatal conditions	None	View
tachycardia	None	Cardiac disorders	None	View
atrial flutter	None	Cardiac disorders	None	View
suparventricular extrasystoles	None	Cardiac disorders	None	View
hand fracture	None	Injury, poisoning and procedural complications	None	View
bronchitis	None	Respiratory, thoracic and mediastinal disorders	None	View
diarrhea	None	Gastrointestinal disorders	None	View
cardiac failure	None	Cardiac disorders	None	View
gastrointestinal infection	None	Gastrointestinal disorders	None	View
staphylococcal sepsis	None	Infections and infestations	None	View
pneumonia aspiration	None	Respiratory, thoracic and mediastinal disorders	None	View
chest pain	None	Respiratory, thoracic and mediastinal disorders	None	View
spinal fracture	None	Injury, poisoning and procedural complications	None	View
depression	None	Psychiatric disorders	None	View
suicide attempt	None	Psychiatric disorders	None	View
osteoarthritis	None	Musculoskeletal and connective tissue disorders	None	View
urinary tract infection	None	Infections and infestations	None	View
influenza like illness	None	General disorders	None	View
procedural pain	None	General disorders	None	View
renal tubular necrosis	None	Renal and urinary disorders	None	View
blood creatinine abnormal	None	Investigations	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

palpitations	None	Cardiac disorders	None	View
tachycardia	None	Cardiac disorders	None	View
vertigo	None	Ear and labyrinth disorders	None	View
diarrhea	None	Gastrointestinal disorders	None	View
vomiting	None	Gastrointestinal disorders	None	View
abdominal pain upper	None	Gastrointestinal disorders	None	View
abdominal pain	None	Gastrointestinal disorders	None	View
toothache	None	Gastrointestinal disorders	None	View
dyspepsia	None	Gastrointestinal disorders	None	View
flatulence	None	Gastrointestinal disorders	None	View
fatigue	None	General disorders	None	View
edema peripheral	None	General disorders	None	View
pyrexia	None	General disorders	None	View
influenza like illness	None	General disorders	None	View
nasopharyngitis	None	Infections and infestations	None	View
influenza	None	Infections and infestations	None	View
bronchitis	None	Infections and infestations	None	View
sinusitis	None	Infections and infestations	None	View
gastroenteritis	None	Infections and infestations	None	View
upper respiratory tract infection	None	Infections and infestations	None	View
cystitis	None	Infections and infestations	None	View
rhinitis	None	Infections and infestations	None	View
fall	None	Injury, poisoning and procedural complications	None	View
pain in extremity	None	Musculoskeletal and connective tissue disorders	None	View
muscle spasms	None	Musculoskeletal and connective tissue disorders	None	View
headache	None	Nervous system disorders	None	View
cough	None	Respiratory, thoracic and mediastinal disorders	None	View
oropharyngeal pain	None	Respiratory, thoracic and mediastinal disorders	None	View
rash	None	Skin and subcutaneous tissue disorders	None	View