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 @ 11:10 PM
Ignite Modification Date: 2025-12-25 @ 8:43 PM
NCT ID: NCT01379469
Description: None
Frequency Threshold: 5
Time Frame: Serious Adverse Events and Adverse Events were collected for 52 weeks.
Study: NCT01379469
Study Brief: Carbamazepine in Severe Liver Disease Due to Alpha-1 Antitrypsin Deficiency
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Drug-Carbamazepine (Tegretol XR) One arm receives Drug-Carbamazepine (Tegretol XR).All subjects have severe liver disease due to alpha-1-antitrypsin deficiency. Drug-Carbamazepine (Tegretol XR): To reduce the likelihood of hypersensitivity reactions the subjects will be started on 400 mg/day in 2 doses and the dose will be increased weekly by 200mg/day until reaching a stable therapeutic concentration with a dose not exceeding 1200mg/day(or 1000mg/day in subjects less than 15 years of age). The CBZ tablets will be encapsulated, and the placebo group will receive encapsulated tablets without CBZ. 0 None 6 13 13 13 View
Drug-Carbamazepine (Tegretol XR) Placebo One arm receives Carbamazepine (Tegretol-XR) placebo.All subjects have severe liver disease due to alpha-1-antitrypsin deficiency. Carbamazepine (Tegretol XR) Placebo: Carbamazepine (Tegretol XR)Placebo-the subjects will be started on 400mg/day in 2 doses and the dose will be increased weekly by 200 mg/day until reaching a dose not exceeding 1200 mg/day (or 1000 mg/day in subjects less than 15 years of age). The placebo group will receive encapsulated tables without Carbamazepine. 2 None 4 7 7 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vascular SYSTEMATIC_ASSESSMENT Vascular disorders None View
Constitutional SYSTEMATIC_ASSESSMENT General disorders None View
Hematologic SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Metabolic/Laboratory SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Child-Pugh Score Increase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Constitutional SYSTEMATIC_ASSESSMENT General disorders None View
Dermatologic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Endocrine SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Genitourological SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Gynecological SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hematologic SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Metabolic/Laboratory SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neurologic SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vascular SYSTEMATIC_ASSESSMENT Vascular disorders None View