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 @ 2:43 AM
Ignite Modification Date: 2025-12-26 @ 1:23 AM
NCT ID: NCT00645333
Description: None
Frequency Threshold: 5
Time Frame: During therapy and for 30 days after therapy completion
Study: NCT00645333
Study Brief: Phase I/II Study of MK-0752 Followed by Docetaxel in Advanced or Metastatic Breast 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
MK-0752 MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days. None None 16 30 30 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Allergic rhinitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Autoimmune disorder NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dermatology/Skin - Other (Specify) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Device related infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Disease progression NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema limbs NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hand-and-foot syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT General disorders None View
Immune system disorder NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Infection, Lung (pneumonia) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dermatology/Skin - Other (Specify) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry eye syndrome NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
GI - Other (Specify) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemoglobin NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Joint pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nail changes NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Platelets NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sweating NON_SYSTEMATIC_ASSESSMENT General disorders None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Watering eyes NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Breast pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cardiac Arrhythmia - Other (Specify) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema limbs NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hand-and-foot syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hot flashes NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Leukocytes NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pain - Other NON_SYSTEMATIC_ASSESSMENT General disorders None View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Taste alteration NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View