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 @ 4:06 AM
Ignite Modification Date: 2025-12-26 @ 3:03 AM
NCT ID: NCT02770820
Description: None
Frequency Threshold: 0
Time Frame: Up to 12 months
Study: NCT02770820
Study Brief: Laboratory-Treated (Central Memory/Naive) CD8+ T Cells in Treating Patients With Newly Diagnosed or Relapsed Acute Myeloid Leukemia
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 (Autologous CD8 T Cells) Beginning 4 weeks after completion of last course of consolidation chemotherapy, patients receive autologous WT1-TCRc4 gene-transduced CD8+ TCM/TN lymphocytes IV over 1-4 hours on day 0 and again after a minimum of 3 weeks. Beginning 6 hours after the second infusion of T cells, patients also receive aldesleukin SC BID for 14 days in the absence of disease progression or unacceptable toxicity. Patients who have clinically benefitted from T cell therapy may receive additional infusions of T cells and aldesleukin at the discretion of the PI and the attending physician. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Laboratory Biomarker Analysis: Correlative studies 1 None 0 7 6 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View