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 @ 12:35 AM
Ignite Modification Date: 2025-12-25 @ 10:44 PM
NCT ID: NCT01779167
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01779167
Study Brief: Thalidomide, Lenalidomide, and Rituximab for Previously Treated Waldenstrom Macroglobulinemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Patients Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 \& 27) Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 \& 28). Lenalidomide will be initiated at a starting dose of 5 mg. Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc). None None 2 4 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Unconsciousness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Vasovagal Reaction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gastrointestinal stromal tumor NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sick Sinus Syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Transient Ischemic Attacks NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Intermittent Creatinine increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperuricemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Creatinine increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fatigue (worsened) SYSTEMATIC_ASSESSMENT General disorders None View
aphasia SYSTEMATIC_ASSESSMENT General disorders None View