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 @ 5:49 PM
Ignite Modification Date: 2025-12-25 @ 3:15 PM
NCT ID: NCT04070768
Description: None
Frequency Threshold: 0
Time Frame: Up to 8 months
Study: NCT04070768
Study Brief: Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 3: Venetoclax 600 mg + Gemtuzumab Ozogamicin 3 mg/m^2 Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2. Venetoclax: Venetoclax 600mg Daily Dose 6 None 6 12 12 12 View
Cohort 1: Venetoclax 200 mg + Gemtuzumab Ozogamicin 3 mg/m^2 Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2. Venetoclax: Venetoclax 200mg Daily Dose 3 None 2 3 3 3 View
Cohort 2: Venetoclax 400 mg + Gemtuzumab Ozogamicin 3 mg/m^2 Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2. Venetoclax: Venetoclax 400mg Daily Dose 3 None 2 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
RESPIRATORY FAILURE NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
TUMOR LYSIS SYNDROME NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
ANEMIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv5 View
FEBRILE NEUTROPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv5 View
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAEv5 View
SMALL INTESTINAL OBSTRUCTION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
PLATELET COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
PRURITUS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv5 View
RASH MACULO-PAPULAR NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv5 View
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv5 View
SNEEZING NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
URINARY FREQUENCY NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv5 View
WHITE BLOOD CELL DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
ANAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
HEMORRHOIDS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
MUCOSITIS ORAL NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
WEIGHT LOSS NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
ANOREXIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv5 View
BACTEREMIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
BLOOD BILIRUBIN INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
DIZZINESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
DRY MOUTH NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
DYSGEUSIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
EDEMA FACE NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
EYE DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv5 View
FACIAL PAIN NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
FALL NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAEv5 View
GASTROESOPHAGEAL REFLUX DISEASE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
GASTROPARESIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
GENERALIZED EDEMA NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
GENERALIZED MUSCLE WEAKNESS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv5 View
HEPATOBILIARY DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAEv5 View
HYPERGLYCEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPERPHOSPHATEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPERTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv5 View
HYPONATREMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPOPHOSPHATEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPOXIA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
INVESTIGATIONS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
LEUKOCYTOSIS NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv5 View
LUNG INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
LYMPHOCYTE COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
MYALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv5 View
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAEv5 View
ORAL HEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
PAIN NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
PAIN IN EXTREMITY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv5 View
PLEURAL EFFUSION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
SINUS TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv5 View
SORE THROAT NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
THRUSH NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv5 View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
WEIGHT GAIN NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
WHEEZING NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
ANEMIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv5 View
BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv5 View
CHILLS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
DIARRHEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
DRY EYE NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv5 View
DYSPNEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv5 View
EDEMA LIMBS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
FEBRILE NEUTROPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv5 View
FEVER NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv5 View
HYPOCALCEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPOKALEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
HYPOMAGNESEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv5 View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv5 View
LOCALIZED EDEMA NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv5 View
NEUTROPHIL COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv5 View
NON-CARDIAC CHEST PAIN NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv5 View