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 @ 11:14 PM
Ignite Modification Date: 2025-12-25 @ 8:50 PM
NCT ID: NCT04448756
Description: None
Frequency Threshold: 5
Time Frame: Baseline up to Day 60
Study: NCT04448756
Study Brief: Study of M5049 in Participants With COVID-19 Pneumonia (ANEMONE)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants received matched placebo tablets to M5049 daily for 14 days. 2 None 9 49 12 49 View
M5049 50 Milligram (mg) Participants received M5049 50 milligram (mg) orally twice daily for 14 days. 1 None 5 54 15 54 View
M5049 100 mg Participants received M5049 100 mg orally twice daily for 14 days. 0 None 1 46 10 46 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 24.0 View
Gastric ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.0 View
Upper gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.0 View
Clostridium difficile infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 24.0 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 24.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 24.0 View
Oxygen saturation decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 24.0 View
Diabetic metabolic decompensation NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 24.0 View
Carpal tunnel syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 24.0 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 24.0 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 24.0 View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sinus bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 24.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 24.0 View
Transaminases increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 24.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 24.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 24.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 24.0 View