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 @ 4:16 PM
Ignite Modification Date: 2025-12-25 @ 2:14 PM
NCT ID: NCT00995566
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 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 0
Time Frame: None
Study: NCT00995566
Study Brief: A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Thelin Registry Patients The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics. None None 6 54 6 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Hyperparathyroidism primary NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 14.0 View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Hepatitis toxic NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Injection site infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Pulmonary arterial hypertension NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Pulmonary hypertension NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Anal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View