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 @ 1:27 AM
Ignite Modification Date: 2025-12-25 @ 11:38 PM
NCT ID: NCT01892293
Description: Participants who received NY-ESO-1ᶜ²⁵⁹T
Frequency Threshold: 5
Time Frame: Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Study: NCT01892293
Study Brief: CT Antigen TCR-Engineered T Cells for 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
NY-ESO-1ᶜ²⁵⁹T Cells Administered IV Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells) 2 None 1 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Humerus fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 18 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
Benign neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View
Hypertriglyceridemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
Sinus bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View