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 @ 3:45 AM
Ignite Modification Date: 2025-12-26 @ 2:31 AM
NCT ID: NCT04414202
Description: adverse event collected with CTCAE. no serious adverse event appeared
Frequency Threshold: 0
Time Frame: collection from the baseline to 120 months after treatment by radiotherapy
Study: NCT04414202
Study Brief: Observational Study of Intra-operative Partial Irradiation of Invasive Ductal Breast Carcinomas With a Good Prognosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
1 GROUP Patient with an Invasive breast cancer with a good prognosis that is accessible to breast-conserving surgery. The treatment combines extended tumorectomy with axillary dissection (sentinel lymph node) in addition to 20 Gy of per-operative partial irradiation at the tumor Follow up after this treatment will scheduled 10 years tumorectomy with axillary dissection (sentinel lymph node): All patients will have local excision of the primary tumor following appropriate clinical work-up. Surgery will be done according to usual local practice with a complete excision of the tumor. The aim of the local excision should be to achieve a minimum free margin of 2 mm whilst maintaining a good cosmetic outcome. per-operative partial irradiation: 20 Gy of per-operative partial irradiation at the tumor site during the surgery 39 None 0 519 519 519 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
atrophy SYSTEMATIC_ASSESSMENT General disorders None View
cutaneous eruption SYSTEMATIC_ASSESSMENT General disorders None View
fibrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
hyperpigmentation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
erythema redness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
telangiectasia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
ulceration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View