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 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
NCT ID:
NCT04502433
Description:
Analysis of adverse events (AEs) was performed on TEAEs, defined as AEs that started at or after treatment start (for the poractant alfa group) or at or after randomisation (for the control group).
Safety set (SAF) was used to evaluate AEs and serious AEs (SAEs). The SAF included all enrolled patients, except for one, who was randomised to receive poractant alfa was not treated. All patients included in the SAF were also included in the ITT.
Frequency Threshold:
0
Time Frame:
From screening procedures (Day 0) to the end of the study (Day 28).
Study:
NCT04502433
Study Brief:
Poractant Alfa (Curosurf®)) -- Effect in Adult Patients Diagnosed With 2019 Novel Coronavirus (SARS-COV-19; (Covid-19)) Acute Respiratory Distress Syndrome (ARDS)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Poractant Alfa Treated Cohort | Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC) | 4 | None | 5 | 13 | 11 | 13 | View |
| Control Cohort | Patients receiving standard-of-care (SoC) | 2 | None | 3 | 8 | 5 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrioventricular block | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.0 | View |
| Cardiogenic shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.0 | View |
| Right ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.0 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Pneumatosis intestinalis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Multiple organ dysfunction syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Soft tissue injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Cerebral artery embolism | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.0 | View |
| Bicytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.0 | View |
| Nosocomial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Post procedural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Cerebral disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.0 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.0 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.0 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Impaired gastric emptying | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Hyperpyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Hyperthermia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Haemophagocytic lymphohistiocytosis | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 23.0 | View |
| Aspergillus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Bacterial sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Empyema | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Enterococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Pneumococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Pneumonia klebsiella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Proteus infection | 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 |
| Staphylococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Urinary tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Refractoriness to platelet transfusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| Neutrophil count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| Hypernatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.0 | View |