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 @ 12:22 AM
Ignite Modification Date: 2025-12-25 @ 10:26 PM
NCT ID: NCT02664558
Description: None
Frequency Threshold: 5
Time Frame: 7 months
Study: NCT02664558
Study Brief: A Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ubenimex ubenimex capsules 150 mg three times a day (TID), administered orally for a total of 24 weeks. ubenimex 0 None 9 41 39 41 View
Placebo placebo capsules TID, administered orally for a total of 24 weeks placebo 0 None 2 20 18 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tracheobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Progressive pulmonary hypertension SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diarrhoea infectious SYSTEMATIC_ASSESSMENT General disorders None View
Complication associated with device SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View