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 @ 6:51 PM
Ignite Modification Date:
2025-12-25 @ 4:23 PM
NCT ID:
NCT04417257
Description:
Any AE that occurred from the first dose of study treatment until the End-of-Study follow-up, on Day 60, or until early termination or death, whichever occurred first, was considered treatment-emergent (TEAE). Since participants are already hospitalized, other hospitalization for routine or planned clinical procedures, prolongation of hospitalization for any COVID-19-related adverse change in the subject's condition, or for "social" reasons, were not considered as a serious AE.
Frequency Threshold:
5
Time Frame:
Adverse events were collected from the time of informed consent until the End-of-Study follow-up on Day 60, or until early termination or death, whichever occurred first.
Study:
NCT04417257
Study Brief:
Study of LAU-7b for the Treatment of Coronavirus Disease 2019 (COVID-19) Disease in Adults
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| LAU-7b Phase 2 | Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 300 mg per day for the first 3 days, followed by 200 mg per day | 14 | None | 23 | 117 | 97 | 117 | View |
| Placebo Phase 2 | Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 3 capsules per day for the first 3 days, and 2 capsules per day for the following days. | 11 | None | 22 | 115 | 94 | 115 | View |
| Placebo Phase 3 | Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 3 capsules per day for the first 3 days, and 2 capsules per day for the following days. | 1 | None | 13 | 62 | 54 | 62 | View |
| LAU-7b Phase 3 | Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 300 mg per day for the first 3 days, followed by 200 mg per day | 3 | None | 12 | 57 | 45 | 57 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 23.0 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 23.0 | View |
| Obstruction gastric | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 23.0 | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 23.0 | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | medDRA 23.0 | View |
| COVID-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 23.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 23.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 23.0 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 23.0 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | medDRA 23.0 | View |
| Subdural hematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | medDRA 23.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | medDRA 23.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | medDRA 23.0 | View |
| Aphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 23.0 | View |
| Cerebellar infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 23.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 23.0 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 23.0 | View |
| Ischaemic cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 23.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | medDRA 23.0 | View |
| Completed suicide | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | medDRA 23.0 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | medDRA 23.0 | View |
| Paranoia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | medDRA 23.0 | View |
| Acute respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 23.0 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 23.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 23.0 | View |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 23.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 23.0 | View |
| Organizing pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 23.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 23.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 23.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 23.0 | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 23.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA 23.0 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA 23.0 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA 23.0 | View |
| Arterial haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | medDRA 23.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | medDRA 23.0 | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | medDRA 23.0 | View |
| Idiopathic neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | medDRA 23.0 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | medDRA 23.0 | View |
| Atrioventricular block complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | medDRA 23.0 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | medDRA 23.0 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | medDRA 23.0 | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | medDRA 23.0 | View |
| Cardiogenic shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | medDRA 23.0 | View |
| Cor pulmonale acute | SYSTEMATIC_ASSESSMENT | Cardiac disorders | medDRA 23.0 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | medDRA 23.0 | View |
| Pulseless electrical activity | SYSTEMATIC_ASSESSMENT | Cardiac disorders | medDRA 23.0 | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | medDRA 23.0 | View |
| Duodenal ulcer haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 23.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 23.0 | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 23.0 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | medDRA 23.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 23.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 23.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 23.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 23.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 23.0 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 23.0 | View |
| Hyperglicaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA 23.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA 23.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | medDRA 23.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 23.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 23.0 | View |
| Taste disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 23.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | medDRA 23.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA 23.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 23.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 23.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 23.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | medDRA 23.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | medDRA 23.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | medDRA 23.0 | View |