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 @ 11:02 PM
Ignite Modification Date: 2025-12-25 @ 8:32 PM
NCT ID: NCT00656669
Description: None
Frequency Threshold: 5
Time Frame: Cycles 1 through 9 of treatment
Study: NCT00656669
Study Brief: Exploratory Study of Sunitinib Malate as a Component of Neoadjuvant Therapy for 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
Single Agent Sunitinib Single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation. None None 0 23 20 23 View
Paclitaxel/Sunitinib 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel. None None 2 23 22 23 View
AC Dosing 4 cycles (8 weeks) of neoadjuvant treatment with AC. None None 2 16 16 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
BILIRUBIN (HYPERBILIRUBINEMIA) NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
NEUTROPHILS/GRANULOCYTES (ANC/AGC) NON_SYSTEMATIC_ASSESSMENT Investigations None View
LEFT VENTRICULAR SYSTOLIC DYSFUNCTION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE NON_SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
OCULAR/VISUAL - OTHER (SPECIFY, __) NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
VISION-BLURRED VISION NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DIARRHEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
HEARTBURN/DYSPEPSIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
HEMORRHOIDS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - ORAL CAVITY NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - STOMACH NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
TASTE ALTERATION (DYSGEUSIA) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
FATIGUE (ASTHENIA, LETHARGY, MALAISE) NON_SYSTEMATIC_ASSESSMENT General 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 - ABDOMEN NOS NON_SYSTEMATIC_ASSESSMENT General disorders None View
PAIN - BACK NON_SYSTEMATIC_ASSESSMENT General disorders None View
PAIN - BREAST NON_SYSTEMATIC_ASSESSMENT General disorders None View
PAIN - CARDIAC/HEART NON_SYSTEMATIC_ASSESSMENT General disorders None View
PAIN - CHEST/THORAX NOS NON_SYSTEMATIC_ASSESSMENT General disorders None View
PAIN - HEAD/HEADACHE NON_SYSTEMATIC_ASSESSMENT General disorders None View
PAIN - JOINT NON_SYSTEMATIC_ASSESSMENT General disorders None View
PAIN - MUSCLE NON_SYSTEMATIC_ASSESSMENT General disorders None View
PAIN - OTHER (SPECIFY, __) NON_SYSTEMATIC_ASSESSMENT General disorders None View
PAIN - STOMACH NON_SYSTEMATIC_ASSESSMENT General disorders None View
PAIN - THROAT/PHARYNX/LARYNX NON_SYSTEMATIC_ASSESSMENT General disorders None View
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - PARANASAL NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SINUS NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SKIN (CELLULITIS) NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
INFECTION WITH UNKNOWN ANC - URINARY TRACT NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
BURN NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE) 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
NEUTROPHILS/GRANULOCYTES (ANC/AGC) NON_SYSTEMATIC_ASSESSMENT Investigations None View
PLATELETS NON_SYSTEMATIC_ASSESSMENT Investigations None View
ANOREXIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
NEUROPATHY: SENSORY 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
HOT FLASHES/FLUSHES 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
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
DRY SKIN NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
HYPOPIGMENTATION NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
NAIL CHANGES NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
PRURITUS/ITCHING NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RASH/DESQUAMATION NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RASH: ACNE/ACNEIFORM NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RASH: HAND-FOOT SKIN REACTION NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
HYPERTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
DERMAL CHANGE LYMPHEDEMA, PHLEBOLYMPHEDEMA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
LEFT VENTRICULAR SYSTOLIC DYSFUNCTION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
VENTRICULAR ARRHYTHMIA - VENTRICULAR TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
DRY EYE SYNDROME NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
PAIN - EXTREMITY-LIMB NON_SYSTEMATIC_ASSESSMENT General disorders None View
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
HAIR LOSS/ALOPECIA (SCALP OR BODY) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
HYPERPIGMENTATION NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View