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 @ 4:37 PM
Ignite Modification Date: 2025-12-25 @ 2:27 PM
NCT ID: NCT04382066
Description: 2 patients die during the study, one of Arm A on day 22 due to COVID-19 pneumonia and pneumomediastinum and the other of Arm C at day 30 due to disease-related acute respiratory distress syndrome.
Frequency Threshold: 5
Time Frame: From first administration of plitidepsin until day 31.
Study: NCT04382066
Study Brief: Proof of Concept Study to Evaluate the Safety Profile of Plitidepsin in Patients With COVID-19
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental 1 Plitidepsin 1.5 mg / day x 3 consecutive days 1 None 6 15 15 15 View
Experimental 2 Plitidepsin 2.0 mg / day x 3 consecutive days 0 None 1 15 14 15 View
Experimental 3 Plitidepsin 2.5 mg / day x 3 consecutive days 1 None 3 15 15 15 View
Total All the 45 patients treated with at least 1 dose of plitidepsin were analyzed for safety. 2 None 10 45 44 45 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders 23.1 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 23.1 View
Status epilepticus SYSTEMATIC_ASSESSMENT Nervous system disorders 23.1 View
Pneumomediastinum SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 23.1 View
Condition aggravated SYSTEMATIC_ASSESSMENT General disorders 23.1 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations 23.1 View
Superinfection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations 23.1 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 23.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 23.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin candida SYSTEMATIC_ASSESSMENT Infections and infestations 23.1 View
Neutrophil count increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
Interleukin level increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 23.1 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 23.1 View
Pneumothorax spontaneous SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 23.1 View
Tenosynovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 23.1 View
Triglycerides increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
Fibrin D dimer increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 23.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 23.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 23.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 23.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 23.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders 23.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 23.1 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 23.1 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 23.1 View
Neutrophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 23.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders 23.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders 23.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders 23.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 23.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 23.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 23.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 23.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 23.1 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 23.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 23.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 23.1 View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations 23.1 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 23.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 23.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 23.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations 23.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 23.1 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
ALT increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
AST increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
Blood fibrinogen increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
CPK increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
Ferritin increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
GGT increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
LDH increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
LDL increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations 23.1 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 23.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 23.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 23.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 23.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 23.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders 23.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders 23.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 23.1 View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders 23.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders 23.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders 23.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders 23.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders 23.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders 23.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders 23.1 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders 23.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders 23.1 View
Prerenal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders 23.1 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders 23.1 View
Breast engorgement SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 23.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 23.1 View
Chest discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 23.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 23.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 23.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 23.1 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 23.1 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 23.1 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 23.1 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 23.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders 23.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders 23.1 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders 23.1 View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders 23.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders 23.1 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders 23.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders 23.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders 23.1 View
Temperature regulation disorder SYSTEMATIC_ASSESSMENT General disorders 23.1 View