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 @ 12:36 PM
Ignite Modification Date: 2025-12-25 @ 12:11 PM
NCT ID: NCT01069861
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 0
Time Frame: None
Study: NCT01069861
Study Brief: Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sildenafil Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant. None None 1 4 3 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Congenital pneumonia NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v15.0 View
Persistent foetal circulation NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiac disorder NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v15.0 View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v15.0 View
Infusion site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v15.0 View
Blood lactic acid increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v15.0 View
C-reactive protein increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v15.0 View
Intraventricular haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v15.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v15.0 View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v15.0 View
Respiratory distress NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v15.0 View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v15.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v15.0 View
Pulmonary haemorrhage NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v15.0 View
Incorrect drug administration duration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v15.0 View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v15.0 View