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: 2025-12-25 @ 3:37 AM
Ignite Modification Date: 2025-12-26 @ 2:21 AM
NCT ID: NCT04770402
Description: Only All-Cause Mortality, Serious Adverse Events, and Adverse Events of Special Interest (AESI) were collected for this study. All-cause mortality and Serious Adverse Events were collected for both arms as defined in the clinicaltrials.gov definition. AESIs were collected only for subjects on the intervention arm, including bleeding, bruising, skin infection, edema, dry skin, urticaria, pruritus, rash, pain or flushing at the acupuncture site, dizziness, syncope, fatigue, or hyperhidrosis.
Frequency Threshold: 0
Time Frame: AESIs were collected for approximately 10 weeks for the duration of the acupuncture treatment (for those on the intervention arm) and collected through 30 days after last acupuncture session. Serious adverse events and all-cause mortality were monitored and collected for both arms throughout the study, approximately 10 weeks.
Study: NCT04770402
Study Brief: Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma 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
Acupuncture Acupuncture: 12 acupuncture sessions over 10 weeks 0 None 0 8 0 8 View
Standard of Care Standard of Care CIPN management: Investigator directed standard of care management of CIPN 0 None 0 4 0 0 View
Serious Events(If Any):
Other Events(If Any):