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 @ 10:16 PM
Ignite Modification Date:
2025-12-25 @ 7:50 PM
NCT ID:
NCT02255435
Description:
After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.
Frequency Threshold:
2
Time Frame:
16 weeks for Part 1 and 52 weeks for Part 2
Study:
NCT02255435
Study Brief:
A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 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 |
|---|---|---|---|---|---|---|---|---|
| Part 1 Omaveloxolone Capsules 2.5 and 5 mg | Omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg administered orally once daily for 10 weeks Omaveloxolone Capsules, 2.5 mg Omaveloxolone Capsules, 5 mg | 0 | None | 0 | 6 | 6 | 6 | View |
| Part 1 Omaveloxolone Capsules 10 mg | Omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks Omaveloxolone Capsules, 10 mg | 0 | None | 0 | 6 | 5 | 6 | View |
| Part 1 Omaveloxolone Capsules 20 mg | Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks Omaveloxolone Capsules, 20 mg | 0 | None | 0 | 6 | 5 | 6 | View |
| Part 1 Omaveloxolone Capsules 40 mg | Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks Omaveloxolone Capsules, 40 mg | 0 | None | 0 | 6 | 6 | 6 | View |
| Part 1 Omaveloxolone Capsules 80 mg | Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks Omaveloxolone Capsules, 80 mg | 0 | None | 0 | 6 | 6 | 6 | View |
| Part 1 Omaveloxolone Capsules 160 mg | Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks Omaveloxolone Capsules, 160 mg | 0 | None | 0 | 12 | 11 | 12 | View |
| Part 1 Omaveloxolone Capsules 300 mg | Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks Omaveloxolone Capsules, 300 mg | 0 | None | 0 | 10 | 10 | 10 | View |
| Part 1 Placebo Capsules | Placebo capsules administered orally once daily for 12 weeks Placebo | 0 | None | 2 | 17 | 16 | 17 | View |
| Part 2 Placebo Capsules | Placebo capsules administered orally once daily for 48 weeks Placebo | 0 | None | 3 | 52 | 52 | 52 | View |
| Part 2 Omaveloxolone Capsules 150 mg | Omaveloxolone (RTA 408) Capsules, 150 mg administered orally once daily for 48 weeks Omaveloxolone Capsules, 150 mg | 0 | None | 5 | 51 | 51 | 51 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.1) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.1) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.1) | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.1) | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.1) | View |
| Drug withdrawal syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Gallbladder disorder | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (14.1) | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Burns third degree | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Craniocerebral injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.1) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.1) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.1) | View |
| Ventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.1) | View |
| Friedreich's ataxia | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (14.1) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.1) | View |
| Ocular hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.1) | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Abnormal faeces | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Gastrointestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Gastrointestinal viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Pharyngitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Respiratory tract infection viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Burns second degree | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Burns third degree | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Excoriation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Face injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Joint dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Muscle strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Periorbital haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Sunburn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Brain natriuretic peptide increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Glucose urine present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Very low density lipoprotein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.1) | View |
| Hypertriglyceridaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.1) | View |
| Increased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Exostosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Muscle twitching | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Pain in jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Autonomic nervous system imbalance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Muscle spasticity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Psychomotor hyperactivity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.1) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.1) | View |
| Euphoric mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.1) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.1) | View |
| Micturition urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.1) | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.1) | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (14.1) | View |
| Ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (14.1) | View |
| Choking | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Paranasal sinus hypersecretion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Pulmonary congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.1) | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.1) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.1) | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.1) | View |
| Petechiae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.1) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.1) | View |
| Rash generalised | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.1) | View |
| Rash macular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.1) | View |
| Skin exfoliation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.1) | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.1) | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.1) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Energy increased | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (14.1) | View |
| Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |