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 @ 2:58 PM
Ignite Modification Date: 2025-12-25 @ 1:23 PM
NCT ID: NCT01226459
Description: None
Frequency Threshold: 2.0
Time Frame: None
Study: NCT01226459
Study Brief: Clinical Trial in Females for Female Pattern Hair Loss
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vehicle Foam Vehicle Topical Foam Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks None None 4 201 57 201 View
Minoxidil Foam 5% Minoxidil Topical Foam 5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks None None 6 203 63 203 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ovarian Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.1 View
Ovarian Neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.1 View
Uterine Leiomyoma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Cardiovascular Disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Cor Pulmonale Acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.1 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.1 View
Memory Impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Mental Status Changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Post-Traumatic Stress Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.1 View
Hypertensive Crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Weight Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.1 View