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 @ 2:52 PM
Ignite Modification Date: 2025-12-25 @ 1:18 PM
NCT ID: NCT00438659
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00438659
Study Brief: Mometasone Furoate in Preventing Radiation Dermatitis in Patients Undergoing Radiation Therapy to the Breast or Chest Wall for Invasive Breast Cancer or Ductal Carcinoma in Situ
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mometasone Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy. None None 0 84 75 84 View
Placebo Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B. None None 0 82 81 82 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Dermatitis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10 View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Atrophy skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Skin striae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View