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 @ 2:26 AM
Ignite Modification Date: 2025-12-26 @ 12:59 AM
NCT ID: NCT02481934
Description: None
Frequency Threshold: 5
Time Frame: 4 months during treatment with NKAE cells.
Study: NCT02481934
Study Brief: Clinical Trial of Expanded and Activated Autologous NK Cells to Treat 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
NKAE Cells Infusion + Chemotherapy Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib). NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle. Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles. Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles. None None 2 5 2 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastrointestinal bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3.0 View
Vertebral compression NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE 3.0 View