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 @ 2:20 AM
Ignite Modification Date: 2025-12-26 @ 12:51 AM
NCT ID: NCT03330834
Description: Serious Cytokine Release Syndrome causes interstitial pneumonia disease. CTCAE grade 4, possibly drug related. Febrile without any courses and respiratory distress that deteriorated quickly into failure in 3 days.He was immediately transferred to the ICU where he received oxygen via nasal cannula and given intravenous infusions of tocilizumab and large doses of methylprednisolone. His symptoms were quickly improved and the pulmonary inflammation became dissipated gradually.
Frequency Threshold: 0
Time Frame: 24 months
Study: NCT03330834
Study Brief: CAR-T Cell Immunotherapy for Advanced Lung Cancer
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 Arm CAR-T cells to treat advanced lung cancer. This study has only one arm. All participators will attend the screening and meet the set criteria for the clinical treatment. PD-L1 CAR-T cells are infused on day 0 with 10%, day 3 with 30% and day 7 with 60% , (1-2)×10\^6/kg PD-L1 CAR-T cells total. CAR-T cells to treat advanced lung cancer: Drug: fludarabine. On days -4 through -2, fludarabine (25mg/m2) will be infused for 3 consecutive days; Drug: cyclophosphamide. On days -4 through -2, cyclophosphamide (250mg/m2) will be infused for 3 consecutive days. Patients will receive the above chemotherapy for lymphocyte-depletion followed by PD-L1 CAR-T cells. 1 None 1 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
interstitial pneumonia disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Serious Cytokine Release Syndrome causes interstitial pneumonia disease. SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.02) View
Uric acid elevation SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.02) View
Chest pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.02) View
thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.02) View
hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.02) View
toothache SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.02) View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.02) View
Albumin decline SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.02) View
swelling of eye SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.02) View
C-Reactive Protein SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.02) View
proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.02) View
White blood cell counts increasing SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.02) View
neutrophilic granulocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.02) View
upper respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.02) View