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 @ 4:18 PM
Ignite Modification Date: 2025-12-25 @ 2:15 PM
NCT ID: NCT00868166
Description: Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
Frequency Threshold: 5
Time Frame: Safety was assessed during the 18-months study duration.
Study: NCT00868166
Study Brief: Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Olesoxime 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid. Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid. Riluzole: Riluzole given as add-on therapy 50mg bid. 79 None 68 259 98 259 View
Placebo Comparator 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid 80 None 65 253 101 253 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View
Bronchial obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View
Choking SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View
Increased bronchial secretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View
Respiratory arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View
Bronchial secretion retention SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View
Haemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View
Hypoventilation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View
Nocturnal dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View
Respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 11.0 View
Lobar pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 11.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 11.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 11.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 11.0 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 11.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 11.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 11.0 View
Gastrointestinal fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 11.0 View
Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 11.0 View
Post procedural infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 11.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 11.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 11.0 View
Chest injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 11.0 View
Craniocerebral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 11.0 View
Device breakage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 11.0 View
Face injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 11.0 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 11.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 11.0 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 11.0 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 11.0 View
Joint sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 11.0 View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 11.0 View
Poisoning deliberate SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 11.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 11.0 View
Traumatic brain injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 11.0 View
Traumatic intracranial haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 11.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, version 11.0 View
Acute abdomen SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, version 11.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, version 11.0 View
Faecaloma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, version 11.0 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, version 11.0 View
Impaired gastric emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, version 11.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, version 11.0 View
Pneumoperitoneum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, version 11.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, version 11.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA, version 11.0 View
Aortic dissection SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA, version 11.0 View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA, version 11.0 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA, version 11.0 View
Pelvic venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA, version 11.0 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA, version 11.0 View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA, version 11.0 View
Venous thrombosis limb SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA, version 11.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA, version 11.0 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA, version 11.0 View
Areflexia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA, version 11.0 View
Cerebral haematoma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA, version 11.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA, version 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA, version 11.0 View
Embolic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA, version 11.0 View
Hypercapnic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA, version 11.0 View
Meningorrhagia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA, version 11.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA, version 11.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA, version 11.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA, version 11.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA, version 11.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA, version 11.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA, version 11.0 View
Application site inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA, version 11.0 View
Application site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA, version 11.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA, version 11.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA, version 11.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA, version 11.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA, version 11.0 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA, version 11.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA, version 11.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA, version 11.0 View
Completed suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA, version 11.0 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA, version 11.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA, version 11.0 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA, version 11.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA, version 11.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA, version 11.0 View
Bronchial carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA, version 11.0 View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA, version 11.0 View
Tongue neoplasm malignant stage unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA, version 11.0 View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA, version 11.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA, version 11.0 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA, version 11.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA, version 11.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA, version 11.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA, version 11.0 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA, version 11.0 View
Troponin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA, version 11.0 View
Mechanical ventilation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA, version 11.0 View
Hysterectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA, version 11.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA, version 11.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA, version 11.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA, version 11.0 View
Haemolytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA, version 11.0 View
Alcoholic liver disease SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA, version 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, version 11.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, version 11.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 11.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 11.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA, version 11.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA, version 11.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 11.0 View