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 @ 2:13 AM
Ignite Modification Date: 2025-12-26 @ 12:41 AM
NCT ID: NCT02043860
Description: None
Frequency Threshold: 1
Time Frame: 2 years
Study: NCT02043860
Study Brief: Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Multiple Myeloma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1 TMI Dose 3Gy This is a phase I trial. Patients will receive standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will include targeted total marrow irradiation (TMI). The dose of TMI will increase until the maximum tolerated dose (MTD) is reached. 3 participants will be in each cohort beginning with the lowest possible dose of 3Gy to a maximum dose of 12Gy. All Cause Mortality Total 0/2 0% Serious Adverse Events Total 0/2 0% Adverse Events not including serious adverse events Total 2/2 100% Oral Mucositis 2/2 100% Diarrhea 2/2 100% Nausea 1/2 50% Non-productive cough 1/2 50% Rash to face and back 1/2 50% Throat pain 1/2 50% GI bleed 1/2 50% 0 None 0 2 2 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GI bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Throat pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Rash to face and back SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Non-productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shortness of breath on exertion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View