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 @ 2:59 PM
Ignite Modification Date: 2025-12-25 @ 1:23 PM
NCT ID: NCT00550459
Description: collection/elicitation of adverse event incidence
Frequency Threshold: 5
Time Frame: 28 Days
Study: NCT00550459
Study Brief: Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic 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
Placebo Placebo tablet given once daily for 21 days None None 1 28 13 28 View
Tolvaptan (15-60 mg) Tolvaptan tablet 15-60 mg given once daily for 21 days None None 2 29 17 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
Large intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Abdominal adhesions NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Pollakiuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (10.0) View
Thirst NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Urine output increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View