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: 2025-12-24 @ 7:22 PM
Ignite Modification Date: 2025-12-25 @ 5:01 PM
NCT ID: NCT00005803
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00005803
Study Brief: Autologous Stem Cell Transplant Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoma
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 (Tandem Transplantation) See Detailed Description Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous transplantation Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation Carmustine: Given IV Cyclophosphamide: Given IV Cyclosporine: Given PO Cytarabine: Given IV Etoposide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplantation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic transplantation Therapeutic Autologous Lymphocytes: IV donor lymphocyte infusion Total-Body Irradiation: Undergo radiotherapy None None 10 76 24 76 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tachycardia, intubation, sepsis and pulmonary embolus NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pulmonary failure requiring intubation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Death due to infection with pericardial and epicardial involvement NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory arrest due to disease progression NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxemia during PBSC infusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bowel perforation and sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis with respiratory failure and mental status changes NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Death due to multiple pulmonary infections NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypoxia due to organizing pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Intra-abdominal hemorrhage when undergoing VATS procedure NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Seizures NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Increased Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diffuse Alveolar Hemorrhage NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View