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 @ 2:50 PM
Ignite Modification Date: 2025-12-25 @ 1:17 PM
NCT ID: NCT04784559
Description: As pre-specified in the approved Protocol and Statistical Analysis Plan of the study "Safety analyses will be based on the As Treated Population." Adverse events of participants not belonging to the as-treated population: One randomized participant in Plitidepsin 1.5 mg arm, that never received any study treatment, experienced an AE of adult respiratory distress syndrome.
Frequency Threshold: 0
Time Frame: From Screening to Day 31 +/- 3 days
Study: NCT04784559
Study Brief: Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Plitidepsin 2.5 mg Arm Participants received plitidepsin 2.5 mg/day intravenous (IV) in addition to dexamethasone on days 1 to 3. 2 None 11 63 43 63 View
Plitidepsin 1.5 mg Arm Participants received plitidepsin 1.5 mg/day IV in addition to dexamethasone on days 1 to 3. 1 None 6 67 43 67 View
Control Arm Participants received dexamethasone IV on Days 1 to 3. Additionally, in accordance with local treatment guidelines, participants in this group may have received a regulatory-approved antiviral treatment. 2 None 5 65 38 65 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intestinal ischaemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Bronchopulmonary aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pneumonia pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pneumonia streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Frequent bowel movements SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Mouth haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Catheter site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Catheter site phlebitis SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Hepatotoxicity SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Bacteriuria SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Tracheobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Epicondylitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Eschar SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Nerve injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Traumatic haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Serum ferritin abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Procalcitonin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Fibrin D dimer increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Adjusted calcium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Oxygen saturation SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood albumin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Chest X-ray abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Electrocardiogram PR prolongation SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Hepatic enzyme abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Interleukin level decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Interleukin level increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
SARS-CoV-2 test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Troponin T increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Acquired mixed hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypoproteinaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Metabolic alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Myopathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Limb discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Muscle contracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Acrochordon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Thymoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Neuromyopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Psychomotor hyperactivity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Urge incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Perineal erythema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Pruritus genital SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Bronchial hyperreactivity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Bronchial disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Laryngeal oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pneumomediastinum SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Rales SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Subcutaneous emphysema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Peripheral venous disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Normocytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Atrioventricular block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View