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 @ 4:17 AM
Ignite Modification Date: 2025-12-26 @ 3:18 AM
NCT ID: NCT00693420
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT00693420
Study Brief: Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence
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 0.03% Solution None None None 1 None 40 None View
Vehicle Solution None None None 2 None 22 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Squamous cell carcinoma of the skin (back) NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Lymphoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Breast Cancer Metastatic NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye pruritus NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctival hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Pinguecula NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye Irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dry Eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Erythema of eyelid NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eyelids pruritus NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctival haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Blepharal Papilloma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Skin Hyper pigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis Contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View