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: 2025-12-24 @ 3:48 PM
Ignite Modification Date: 2025-12-25 @ 1:56 PM
NCT ID: NCT00445692
Description: None
Frequency Threshold: 5
Time Frame: 10.25 years
Study: NCT00445692
Study Brief: Lenalidomide, Dexamethasone, and Clarithromycin in Treating Patients Who Have Undergone Stem Cell 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
Treatment (Clarithromycin, Dexamethasone, Lenalidomide) Patients receive clarithromycin orally (PO) twice daily and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin. NOTE: \*After one year of treatment, dexamethasone is tapered for an additional 4 weeks. Clarithromycin: Given Orally (PO) Dexamethasone: Given PO Lenalidomide: Given PO 13 None 11 31 19 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Upper Respiratory Syncytial Virus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Varicella-zoster virus pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Peripheral edema SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumocystis Carinii Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
H1N1 influenza / Streptococcus pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Secondary cancer, Acute Myeloid Leukemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Upper respiratory syncytial viurs infection/Leukocytoclastic vasculitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Peripheral Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Investigations None View
upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
sinus/acute otitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
vaginitis SYSTEMATIC_ASSESSMENT Infections and infestations None View