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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
NCT ID:
NCT00993967
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00993967
Study Brief:
Long-Term Safety and Tolerability of Idebenone in Friedreich's Ataxia Patients (MICONOS Extension)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Idebenone | 1350 mg/day or 2250 mg/day for patients weighing ≤45 kg or \>45 kg, respectively.In case of poor tolerability, dose reduction to 450 mg/day or 900 mg/day, respectively, were allowed. idebenone: Idebenone 1350 mg/d, patients \< or equal 45 kg Idebenone 2250 mg/d, patients \> 45 kg | None | None | 49 | 200 | 188 | 200 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| streptococcal infection | None | Infections and infestations | MedDRA (Unspecified) | View |
| Humerus fracture | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| fall | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Atrial fibrillation | None | Cardiac disorders | MedDRA (Unspecified) | View |
| Atrial flutter | None | Cardiac disorders | MedDRA (Unspecified) | View |
| cardiac failure | None | Cardiac disorders | MedDRA (Unspecified) | View |
| talipes | None | Congenital, familial and genetic disorders | MedDRA (Unspecified) | View |
| abdominal pain lower | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| diarrhoea | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| asthma | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| dental caries | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| tooth disorder | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| fibroadenoma of breast | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | View |
| gastroenteritis | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| spinal disorder | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| deep vein thrombosis | None | Vascular disorders | MedDRA (Unspecified) | View |
| pulmonary embolism | None | Vascular disorders | MedDRA (Unspecified) | View |
| ankle fracture | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Cerebrovascular accident | None | Nervous system disorders | MedDRA (Unspecified) | View |
| lower respiratory tract infection | None | Infections and infestations | MedDRA (Unspecified) | View |
| Thermal burn | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Atrial tachycardia | None | Cardiac disorders | MedDRA (Unspecified) | View |
| Reflux oesophagitis | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Pneumonia | None | Infections and infestations | MedDRA (Unspecified) | View |
| Haemorrhage | None | Vascular disorders | MedDRA (Unspecified) | View |
| Pelvic fracture | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Uterine leiomyoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | View |
| Diabetes mellitus inadequate control | None | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| influenza | None | Infections and infestations | MedDRA (Unspecified) | View |
| fibula fracture | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Tibia fracture | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Diabetes mellitus | None | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| proctitis | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Tachycardia | None | Cardiac disorders | MedDRA (Unspecified) | View |
| femur fracture | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| myocardial infarction | None | Cardiac disorders | MedDRA (Unspecified) | View |
| abdominal pain upper | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| calculus ureteric | None | Renal and urinary disorders | MedDRA (Unspecified) | View |
| dehydration | None | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| epilepsy | None | Nervous system disorders | MedDRA (Unspecified) | View |
| torticollis | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| salmonella sepsis | None | Infections and infestations | MedDRA (Unspecified) | View |
| scoliosis | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| prostatitis | None | Reproductive system and breast disorders | MedDRA (Unspecified) | View |
| respiratory failure | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| back pain | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| radiculopathy | None | Nervous system disorders | MedDRA (Unspecified) | View |
| thyroid cancer | None | Endocrine disorders | MedDRA (Unspecified) | View |
| paraplegia | None | Nervous system disorders | MedDRA (Unspecified) | View |
| hand fracture | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| wrist fracture | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| foot deformity | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| corneal erosion | None | Eye disorders | MedDRA (Unspecified) | View |
| ventricular tachycardia | None | Cardiac disorders | MedDRA (Unspecified) | View |
| hypoglycemia | None | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| pneumonia aspiration | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| liver injury | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| constipation | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| diarrhoea | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| nausea | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| pyrexia | None | General disorders | MedDRA (Unspecified) | View |
| bronchitis | None | Infections and infestations | MedDRA (Unspecified) | View |
| cystitis | None | Infections and infestations | MedDRA (Unspecified) | View |
| nasopharyngitis | None | Infections and infestations | MedDRA (Unspecified) | View |
| fall | None | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| pain in extremity | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| headache | None | Nervous system disorders | MedDRA (Unspecified) | View |
| depression | None | Psychiatric disorders | MedDRA (Unspecified) | View |
| oropharyngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| abdominal pain upper | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| vomiting | None | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| influenza | None | Infections and infestations | MedDRA (Unspecified) | View |
| back pain | None | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| dizziness | None | Nervous system disorders | MedDRA (Unspecified) | View |