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: 2025-12-25 @ 1:33 AM
Ignite Modification Date: 2025-12-25 @ 11:46 PM
NCT ID: NCT02445794
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02445794
Study Brief: A First in Human Study of RT001 in Patients With Friedreich's Ataxia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1 - RT001 (1.8 g/Day) RT001, oral, 2 capsules/day RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001. 0 None 0 6 5 6 View
Cohort 1 - Comparator RT001 comparator, oral, 2 capsules/day RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester. 0 None 0 3 2 3 View
Cohort 2 - RT001 (9 g/Day) RT001, oral, 10 capsules/day RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001. 0 None 1 7 5 7 View
Cohort 2 - Comparator RT001 comparator, oral, 10 capsules/day RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester. 0 None 0 3 2 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Steatorrhea requiring overnight hospitalization SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension None Gastrointestinal disorders None View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
facial fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View