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 @ 1:30 PM
Ignite Modification Date: 2025-12-25 @ 12:32 PM
NCT ID: NCT02663895
Description: Adverse event and serious adverse event were defined as per clinicaltrials.gov definitions.
Frequency Threshold: 0
Time Frame: Adverse event data were collected every 3 months up to 12 months and at 13 months from enrollment (3 months, 6 months, 9 month, 12 month and 13 months).
Study: NCT02663895
Study Brief: Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Oral Treprostinil Treprostinil 0.125 mg TID, increased by 0.125 mg TID every 3 to 4 days as tolerated for 12-month period of time. 0 None 0 12 11 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flushing NON_SYSTEMATIC_ASSESSMENT General disorders None View
Jaw Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
epistaxis NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
weight loss NON_SYSTEMATIC_ASSESSMENT General disorders None View