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 @ 2:38 AM
Ignite Modification Date: 2025-12-26 @ 1:15 AM
NCT ID: NCT01241734
Description: Adverse Events were collected irrespective of dose level and therefore cannot be reported by dose level
Frequency Threshold: 0
Time Frame: None
Study: NCT01241734
Study Brief: Study of Lenalidomide in Combination With RICE With Lenalidomide Maintenance Post-Auto Transplant for DLBCL
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RICE + Lenalidomide RICE + Lenalidomide days 1-7 2 None 8 16 15 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
RSV Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neutropenic Fever SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Secondary Primary Malignancy (+MDS) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infectious Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fever (absence of neutropenia) SYSTEMATIC_ASSESSMENT Investigations None View
Sepsis (Gram Positive) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View