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 @ 8:02 PM
Ignite Modification Date: 2025-12-25 @ 5:35 PM
NCT ID: NCT01716104
Description: Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=249, Safety Population)
Frequency Threshold: 0
Time Frame: Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Study: NCT01716104
Study Brief: Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression
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 (2 tablets twice a day): Safety and Efficiency None None 1 124 29 124 View
Afalaza Afalaza (2 tablets twice a day): Safety and Efficiency None None 0 125 25 125 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arthralgia/Meniscus injury/Meniscus operation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Chronic gastritis, exacerbation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Acute respiratory viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Prostatic specific antigen increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Epigastric pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Right-sided inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Swollen tongue SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthenia and Depressive weariness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Labial herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Vasomotor rhinitis chronic, exacerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Discomfort in the oropharynx SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Сough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Allergic contact dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertensive crisis, accompanied by headache and nausea SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Chronic hemorrhoids, exacerbation SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View