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 @ 4:02 AM
Ignite Modification Date: 2025-12-26 @ 2:56 AM
NCT ID: NCT03324802
Description: None
Frequency Threshold: 0
Time Frame: 5 years
Study: NCT03324802
Study Brief: Hypofractionated Radiation Therapy in Preventing Recurrence in Patients With Breast Cancer After Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 1 (Radiation Therapy, 15 Fractions) Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy 0 None 0 54 50 54 View
Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy 0 None 0 53 51 53 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dermatitis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Lymphedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Superficial soft tissue fibrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View