Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 11:33 PM
Ignite Modification Date: 2025-12-25 @ 9:21 PM
NCT ID: NCT01389856
Description: None
Frequency Threshold: 5
Time Frame: Up to 21 Days, plus up to 60 days after end of treatment for serious adverse events
Study: NCT01389856
Study Brief: Persistent Pulmonary Hypertension of the Newborn
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bosentan Bosentan Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube. None None 2 13 9 13 View
Placebo Matching placebo Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube. None None 3 8 2 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
HEPATITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 16.0 View
METABOLIC ACIDOSIS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 16.0 View
HYPERCAPNIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 16.0 View
PNEUMOTHORAX SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 16.0 View
CIRCULATORY COLLAPSE SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 16.0 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
INFECTIOUS DISEASE CARRIER SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 16.0 View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 16.0 View
GENERALISED OEDEMA SYSTEMATIC_ASSESSMENT General disorders MedDRA version 16.0 View
COAGULOPATHY SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 16.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 16.0 View
BILIRUBIN CONJUGATED INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA version 16.0 View
BODY TEMPERATURE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA version 16.0 View
C-REACTIVE PROTEIN INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA version 16.0 View
DYSPHONIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 16.0 View
ENDOTRACHEAL INTUBATION COMPLICATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 16.0 View
GASTRIC HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 16.0 View
HYPOGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 16.0 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 16.0 View
HYPOPHOSPHATAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 16.0 View
METABOLIC ACIDOSIS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 16.0 View
PNEUMOTHORAX SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 16.0 View
METHAEMOGLOBINAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 16.0 View
MITRAL VALVE INCOMPETENCE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 16.0 View
PNEUMOMEDIASTINUM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 16.0 View
PROCEDURAL COMPLICATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 16.0 View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 16.0 View