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: 2025-12-25 @ 2:14 AM
Ignite Modification Date: 2025-12-26 @ 12:43 AM
NCT ID: NCT01210560
Description: In safety analysis, all participants who had taken at least one dose of study medication were included.
Frequency Threshold: 0
Time Frame: Screening to seven days (+ 1 day) after the last dose of study medication.
Study: NCT01210560
Study Brief: Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MR 20 mg Participants received MR tolvaptan 20 mg QD. None None 0 17 5 17 View
MR 20+20 mg Participants received MR tolvaptan 20 mg BID. None None 0 17 10 17 View
MR 60 mg Participants received MR tolvaptan 60 mg QD. None None 0 17 6 17 View
MR 120 mg Participants received MR tolvaptan 120 mg QD. None None 0 12 8 12 View
IR 90+30 mg Participants received IR tolvaptan 90+30 mg QD. None None 0 12 7 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Thirst NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Pollakiuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Polyuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Lip dry NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Feeling cold NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Feeling hot NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Mucosal dryness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Polydipsia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Nervousness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Micturition urgency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Nocturia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Renal pain NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View