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 @ 8:00 PM
Ignite Modification Date: 2025-12-25 @ 5:34 PM
NCT ID: NCT00643604
Description: Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Frequency Threshold: 5
Time Frame: Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8)
Study: NCT00643604
Study Brief: Rapid Switch From Flolan to Remodulin in the Outpatient Clinic
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treprostinil Sodium treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium None None 2 7 6 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Infusion site reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pain in Extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Pain in Jaw NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Sinus headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View