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 @ 12:59 AM
Ignite Modification Date: 2025-12-25 @ 11:12 PM
NCT ID: NCT00715793
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00715793
Study Brief: Combination of Decitabine and Temozolomide in the Treatment of Patients With Metastatic Melanoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DAC (Decitabine) + TMZ (Temozolomide) Comprehensive listing of adverse events are presented in total (includes events from both Phase 1 and and Phase 2 of study). None None 7 39 39 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dyspnea (shortness of breath) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Neuropathy: motor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain, Abdomen NOS SYSTEMATIC_ASSESSMENT General disorders None View
Pain, Back SYSTEMATIC_ASSESSMENT General disorders None View
Peripheral arterial ischemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Albumin, serum-low (hypoalbuminemia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT General disorders None View
Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnea (shortness of breath) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema: limb SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fatigue (asthenia, lethargy, malaise) SYSTEMATIC_ASSESSMENT General disorders None View
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) SYSTEMATIC_ASSESSMENT General disorders None View
Heartburn/dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hemorrhage/Bleeding - Other (Specify, __) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infection with normal ANC or Grade 1 or 2 neutrophils, Skin (cellulitis) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS SYSTEMATIC_ASSESSMENT Infections and infestations None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Leukocytes (total WBC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Metabolic/Laboratory - Other (Specify, __) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Mood alteration, Anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mood alteration, Depression SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mucositis/stomatitis (clinical exam), Oral cavity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neuropathy: sensory SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neutrophils/granulocytes (ANC/AGC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pain, Abdomen NOS SYSTEMATIC_ASSESSMENT General disorders None View
Pain, Back SYSTEMATIC_ASSESSMENT General disorders None View
Pain, Chest wall SYSTEMATIC_ASSESSMENT General disorders None View
Pain, Extremity-limb SYSTEMATIC_ASSESSMENT General disorders None View
Pain, Head/headache SYSTEMATIC_ASSESSMENT General disorders None View
Pain, Joint SYSTEMATIC_ASSESSMENT General disorders None View
Phosphate, serum-low (hypophosphatemia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Platelets SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pruritus/itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash/desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Taste alteration (dysgeusia) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight loss SYSTEMATIC_ASSESSMENT General disorders None View