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 @ 10:32 PM
Ignite Modification Date: 2025-12-25 @ 8:05 PM
NCT ID: NCT00798135
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00798135
Study Brief: A Pilot Trial of Itraconazole Pharmacokinetics in Patients With 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
Itraconazole oral itraconazole 200mg a day until disease progression or unacceptable toxicities. None None 3 13 13 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
PAIN - ABDOMEN NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
PAIN - BACK NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
HEMORRHAGE, GI - UPPER GI NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-LOWER NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PLEURAL EFFUSION (NON-MALIGNANT) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
THROMBOSIS/THROMBUS/EMBOLISM NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
VISION-BLURRED VISION NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
FATIGUE (ASTHENIA, LETHARGY, MALAISE) NON_SYSTEMATIC_ASSESSMENT General disorders None View
NEUROPATHY: SENSORY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
DERMATOLOGY/SKIN NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
DRY SKIN NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SKIN (CELLULITIS) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
OCULAR/VISUAL NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DIARRHEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DISTENSION/BLOATING, ABDOMINAL NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GASTROINTESTINAL NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
HEARTBURN/DYSPEPSIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
PAIN - ABDOMEN NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
TASTE ALTERATION (DYSGEUSIA) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) NON_SYSTEMATIC_ASSESSMENT General disorders None View
PAIN NON_SYSTEMATIC_ASSESSMENT General disorders None View
BILIRUBIN (HYPERBILIRUBINEMIA) NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
ALKALINE PHOSPHATASE NON_SYSTEMATIC_ASSESSMENT Investigations None View
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE) NON_SYSTEMATIC_ASSESSMENT Investigations None View
HEMOGLOBIN NON_SYSTEMATIC_ASSESSMENT Investigations None View
PLATELETS NON_SYSTEMATIC_ASSESSMENT Investigations None View
EDEMA: LIMB NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ANOREXIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
PAIN - BACK NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PAIN - BONE NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PAIN - EXTREMITY-LIMB NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PAIN - JOINT NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
INCONTINENCE, URINARY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
NEUROPATHY: CRANIAL - CN VIII HEARING AND BALANCE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
PAIN - HEAD/HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
SPEECH IMPAIRMENT (E.G., DYSPHASIA OR APHASIA) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
MOOD ALTERATION - ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
MOOD ALTERATION - DEPRESSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - PARANASAL NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SINUS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
INFECTION WITH UNKNOWN ANC - SINUS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PAIN - CHEST WALL NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
URINARY FREQUENCY/URGENCY NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
URINE COLOR CHANGE NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - URINARY TRACT NOS NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
PAIN - BREAST NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
DYSPNEA (SHORTNESS OF BREATH) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
HAIR LOSS/ALOPECIA (SCALP OR BODY) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
PRURITUS/ITCHING NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RASH: ACNE/ACNEIFORM NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
SWEATING (DIAPHORESIS) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
HOT FLASHES/FLUSHES NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View