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 @ 6:32 PM
Ignite Modification Date: 2025-12-25 @ 4:02 PM
NCT ID: NCT00673257
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00673257
Study Brief: Pharmacokinetics of Daunorubicin in Young Patients With 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
Pharmacokinetics of Daunorubicin Chemotherapy Patients Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration \< 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT. None None 0 107 50 107 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
White blood cell decreased None Blood and lymphatic system disorders None View
Lymphocyte count decreased None Blood and lymphatic system disorders None View
Neutrophil count decreased None Blood and lymphatic system disorders None View
Platelet count decreased None Blood and lymphatic system disorders None View
Fibrinogen None Investigations None View
Anorexia None Metabolism and nutrition disorders None View
Constipation None Metabolism and nutrition disorders None View
Diarrhea None Metabolism and nutrition disorders None View
Mucositis oral None Metabolism and nutrition disorders None View
Bone marrow hypocellular None Blood and lymphatic system disorders None View
Anemia None Blood and lymphatic system disorders None View
Nausea None Metabolism and nutrition disorders None View
Proctitis None Metabolism and nutrition disorders None View
Vomiting None Metabolism and nutrition disorders None View
"Vascular disorders - Other, specify" None Vascular disorders None View
Enterocolitis infectious None Infections and infestations None View
Febrile neutropenia None Infections and infestations None View
"Infections and infestations - Other, specify" None Infections and infestations None View
Hypoalbuminemia None Metabolism and nutrition disorders None View
Alanine aminotransferase increased None Metabolism and nutrition disorders None View
Hypocalcemia None Metabolism and nutrition disorders None View
Hypercholestremia None Metabolism and nutrition disorders None View
GGT increased None Metabolism and nutrition disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Lipase None Metabolism and nutrition disorders None View
Hypophosphatemia None Metabolism and nutrition disorders None View
Hyperkalemia None Metabolism and nutrition disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Hypertriglyceridemia None Metabolism and nutrition disorders None View
Syncope None Nervous system disorders None View
Pain in extremity None Musculoskeletal and connective tissue disorders None View
Headache None Nervous system disorders None View
Pain None General disorders None View
Tumor lysis syndrome None Metabolism and nutrition disorders None View