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: 2025-12-25 @ 4:42 AM
Ignite Modification Date: 2025-12-26 @ 3:43 AM
NCT ID: NCT04414618
Description: One participant in the placebo arm was not dosed and therefore was removed from the safety population. One participant was randomized to receive placebo, was mistakenly given 2 doses of opaganib and is therefore included twice, once in each arm.
Frequency Threshold: 0
Time Frame: 6 weeks
Study: NCT04414618
Study Brief: A Study of Opaganib in Coronavirus Disease 2019 Pneumonia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Opaganib Study participants will receive opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours Opaganib: Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, in addition to standard of care (pharmacological and/or supportive). 3 None 3 23 11 23 View
Placebo Study participants will receive placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours Placebo: Study participants will receive placebo 2 x 250 mg capsules (500 mg) every 12 hours, in addition to standard of care (pharmacological and/or supportive). 3 None 5 18 9 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fibrin D dimer increased SYSTEMATIC_ASSESSMENT Investigations None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal wall wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Blood calcium decreased SYSTEMATIC_ASSESSMENT Investigations None View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Glucose tolerance impaired SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations None View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypermagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations None View
Megacolon SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Traumatic chest injury NOS SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Troponin I increased SYSTEMATIC_ASSESSMENT Investigations None View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations None View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders None View