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 @ 9:19 PM
Ignite Modification Date: 2025-12-25 @ 7:07 PM
NCT ID: NCT01292304
Description: None
Frequency Threshold: 0
Time Frame: Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose)
Study: NCT01292304
Study Brief: Tolvaptan for Ascites in Cirrhotic Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tolvaptan Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg None None 1 10 9 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Asterixis SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Cold Sensitivity SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
Dry mouth SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Elevated serum creatinine SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Hyopmagnesemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Hypernatrimia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Lethargy SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Lung pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Mouth soreness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Nighttime blackouts SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Pleuritic chest pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Polydipsia SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Polyphagia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Polyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Stomach cramps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Stress SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Vertigo SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View