Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 7:21 PM
Ignite Modification Date: 2025-12-25 @ 5:00 PM
NCT ID: NCT03422003
Description: Reportable AEs include: * Grade 1, 2, or 3 brachial plexopathy * Grade 3 chest wall pain * Grade 3 lymphedema * Grade 3, 4, or 5 myocardial infarction * Grade 1, 2, 3, 4, or 5 pneumonitis * Grade 3, 4, or 5 treatment related secondary malignancy * Grade 3, 4, or 5 wound infection * Unexpected grade 3 or 4 with a possible, probable, or definite attribution to radiation therapy * Grade 5 (death): all deaths
Frequency Threshold: 0
Time Frame: Adverse events were collected if they occurred any time between initiation of protocol treatment and 3-years after the initiation of protocol treatment. All AEs reported throughout the study period are presented below in the data tables. Sites were asked to only report events listed in the Adverse Event Reporting Description. Some AEs below never occurred during the study period. Additional AEs that did not fall into these categories were also collected and reported.
Study: NCT03422003
Study Brief: Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma
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 2: Conventional Radiation Therapy 25 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 23-25 fractions to the supraclavicular (with or without axillary) lymph nodes. Radiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes. For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes. 2 None 29 201 2 201 View
Arm 1: Hypofractionation 16 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 15 fractions to the supraclavicular (with or without axillary) lymph nodes. Radiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes. For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes. 2 None 37 199 4 199 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Distant recurrence SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.03 View
Local-regional recurrence SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.03 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 4.03 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 4.03 View
Lymphedema SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 4.03 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dehisence SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 4.03 View
Capsular Contracture SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 4.03 View