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 @ 2:12 AM
Ignite Modification Date: 2025-12-26 @ 12:40 AM
NCT ID: NCT01051960
Description: None
Frequency Threshold: 0
Time Frame: 24 weeks
Study: NCT01051960
Study Brief: Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ambrisentan ambrisentan dosed at either 5mg or 10mg orally once per day Ambrisentan: Ambrisentan 5mg or 10mg once daily 0 None 1 12 12 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
edema SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tinea Corporis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fecal incontinence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper respiratory symptoms NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal Congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Joint and body pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Elevated liver function tests NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Edema NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Bronchoalveolar carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pulled muscle NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View