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: 2025-12-26 @ 10:43 PM
Ignite Modification Date: 2025-12-26 @ 10:43 PM
NCT ID: NCT04256512
Description: Patients were evaluated for chemotherapy induced peripheral neuropathy (CIPN).
Frequency Threshold: 0
Time Frame: Adverse event (AE) data were collected prior to each cycle of chemo, at the end of each cycle, and 3 months after chemotherapy.
Study: NCT04256512
Study Brief: Cryotherapy for the Prevention of Taxane-Induced Sensory Neuropathy of the Hands and Feet in Breast Cancer Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Prevention (Elasto Gel Therapy Mittens and Foot Wraps) Patients wear Elasto Gel Therapy Mittens and Foot Wraps on both hands and feet 15 minutes prior to each infusion, during the entire infusion, and for 15 minutes after the completion of each infusion during their three months of treatment. Medical Device Usage and Evaluation: Wear Elasto Gel Therapy Mittens and Foot Wraps Questionnaire Administration: Ancillary studies 0 None 0 93 41 93 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neuropathy during chemotherapy (Grade 1) SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Neuropathy after chemotherapy (Grade 1) SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Neuropathy after chemotherapy (Grade 2) SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Neuropathy at 3 month follow up (Grade 1) SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Neuropathy at 3 month follow up (Grade 2) SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View