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: 2025-12-26 @ 11:49 AM
Ignite Modification Date: 2025-12-26 @ 11:49 AM
NCT ID: NCT04829916
Description: None
Frequency Threshold: 0
Time Frame: Full study period, ie baseline through day 30.
Study: NCT04829916
Study Brief: A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RMC-035 Participants received RMC-035 intravenously RMC-035: Multiple dosing during 48 hours following cardiac surgery 1 None 3 8 6 8 View
Placebo Participants received matching placebo solution intravenously Placebo: Multiple dosing during 48 hours following cardiac surgery 0 None 1 4 1 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.1 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.1 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
Anaphylactoid reaction SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.1 View
Arrhythmia supraventricular SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.1 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.1 View
Small intestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
Impaired healing SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.1 View
Rib fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View