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 @ 4:51 AM
Ignite Modification Date: 2025-12-26 @ 3:52 AM
NCT ID: NCT02551718
Description: Non-hematologic toxicities \>/= grade 3 were recorded from time of assay-guided therapy administration through 14 days after last administration of study therapy Hospitalizations or prolongation of hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e. awaiting transport home) were not considered SAEs. And hospitalization or prolongation of hospitalizations for fever and/or infection were considered expected, and not considered SAEs.
Frequency Threshold: 0
Time Frame: 5 years
Study: NCT02551718
Study Brief: High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute 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
Chemosensitivity Testing Leukemia cells purified from blood or bone marrow samples are analyzed for sensitivity to individual drugs and drug combination and by next generation sequencing. Chemosensitivity Assay: Lab test in which leukemia cells obtained from blood or bone marrow are tested for sensitivity to 115 drugs individually and in certain combinations Cytology Specimen Collection Procedure: Undergo blood or bone marrow collection Gene Expression Analysis: Analysis of leukemia cell genes to identify possible drug targets Genetic Variation Analysis: Analysis of leukemia cell genes to identify possible drug targets In Vitro Sensitivity-Directed Chemotherapy: Receive personalized chemotherapy with one or more of the following drugs: Afatinib Arsenic trioxide Axitinib Azacitidine Bexarotene Bortezomib Bosutinib Busulfan Cabazitaxel Cabozantinib Carfilzomib Ceritinib Cladribine Clofarabine Crizotinib Cytarabine HCl Dabrafenib Dasatinib Daunorubicin HCl Decitabine Erlotinib Etoposide Everolimus Fludarabine Gefitinib Gemcitabine HCl Hydroxyurea Imatinib Irinotecan Lapatinib Lomustine Melphalan Mercaptopurine Methotrexate Mitoxantrone Nelarabine Nilotinib Paclitaxel Pazopanib Pentostatin Ponatinib Pralatrexate Rapamycin Regorafenib Romidepsin Ruxolitinib Sorafenib Sunitinib Temsirolimus Thioguanine Topotecan HCl Trametinib Tretinoin 32 None 11 34 26 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intermittent Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pulmonary Edema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Distress NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhizopus Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic Shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tumor Lysis Syndrome NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenic fever with Sepsis Physiology NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Anaphylaxis NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Enterobacter Cloacae Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypoxemic Respiratory Failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial Fibrillation with RVR NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute Kidney Injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Alanine Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Anorectal Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Aspartate Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Bacteremia Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
C. Diff Colitis with Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Catheter Related Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Central Line Associated DVT NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Coag Negative Staph Bacteremia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Distributive Shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Enterocolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Eye Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Febrile Neutropenia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Granulicatella Adiacens Bacteremia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Heart Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hyperbilirubinemia NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
INR Increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Invasive Fungal Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lung Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral Mucositis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pleural Effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pseudomonas Bacteremia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pulmonary Edema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash Maculopapular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rothia Mucilaginosa Bacteremia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staph Epidermidis Bacteremia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staphylococcus Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Stenotrophomonas Maltophilia Bacteremia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Subdural Hematoma NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transaminitis NON_SYSTEMATIC_ASSESSMENT Investigations None View
Tumor Lysis Syndrome NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View