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 @ 5:20 PM
Ignite Modification Date: 2025-12-25 @ 2:56 PM
NCT ID: NCT01325350
Description: The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
Frequency Threshold: 5
Time Frame: None
Study: NCT01325350
Study Brief: Safety and Efficacy Study of Bimatoprost in the Treatment of Women With 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
Bimatoprost Formulation B Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months. None None 4 60 17 60 View
Vehicle to Bimatoprost Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months. None None 1 61 20 61 View
Minoxidil 2% Solution Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months. None None 1 61 24 61 View
Bimatoprost Formulation A Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months. None None 4 61 17 61 View
Bimatoprost Formulation C Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months. None None 3 60 15 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA (15.0) View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (15.0) View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (15.0) View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (15.0) View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (15.0) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (15.0) View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (15.0) View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (15.0) View
Chondropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (15.0) View
Benign ovarian tumour SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (15.0) View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (15.0) View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (15.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application site pruritis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (15.0) View
Application site dryness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (15.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (15.0) View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (15.0) View
Hypertrichosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (15.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (15.0) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (15.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (15.0) View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (15.0) View