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 @ 2:33 AM
Ignite Modification Date: 2025-12-26 @ 1:09 AM
NCT ID: NCT00121134
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00121134
Study Brief: Bevacizumab With or Without Cyclophosphamide and Methotrexate: A Pilot Study in Women With Operable 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
Group A- Bevacizumab Alone Bevacizumab 15 mg/kg every 3 wks for 1 year None None 1 40 40 40 View
Group B-Bevacizumab+Cyclophosphamide+Methotrexate Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months. None None 3 41 41 41 View
Group C-Bevacizumab + Capcitabine(18 Wks) capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year None None 1 41 41 41 View
Group D-bevacizumab + Capecitibine (24wks) capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year. None None 1 40 40 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT General disorders NCTCAE v.3 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCTCAE v.3 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders NCTCAE v.3 View
Hypertension SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCTCAE v.3 View
Wound Dehiscence SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCTCAE v.3 View
Sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCTCAE v.3 View
Lower GI bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCTCAE v.3 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ALT, SGPT SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCTCAE v.3 View
AST, SGOT SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCTCAE v.3 View
Abdomen, pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCTCAE v.3 View
Alkaline phosphatase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCTCAE v.3 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCTCAE v.3 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders NCTCAE v.3 View
Allergic Reaction SYSTEMATIC_ASSESSMENT Immune system disorders NCTCAE v.3 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCTCAE v.3 View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCTCAE v.3 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders NCTCAE v.3 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCTCAE v.3 View
back,pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCTCAE v.3 View
bicarbonate SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCTCAE v.3 View
bilirubin SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCTCAE v.3 View
bone, pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCTCAE v.3 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Edema limb SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCTCAE v.3 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCTCAE v.3 View
Extrapyramidal movement SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCTCAE v.3 View
Extremity-limb, pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCTCAE v.3 View
fatigue SYSTEMATIC_ASSESSMENT General disorders NCTCAE v.3 View
febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCTCAE v.3 View
fever w/o neutropenia SYSTEMATIC_ASSESSMENT General disorders NCTCAE v.3 View
flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCTCAE v.3 View
Gastrointestinal-other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCTCAE v.3 View
Hand-foot reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCTCAE v.3 View
Head/headache SYSTEMATIC_ASSESSMENT Nervous system disorders NCTCAE v.3 View
hematologic-other SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCTCAE v.3 View
hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCTCAE v.3 View
hemorrhage-other SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCTCAE v.3 View
hemorrhoids SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCTCAE v.3 View
Hot flashes SYSTEMATIC_ASSESSMENT General disorders NCTCAE v.3 View
hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCTCAE v.3 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders NCTCAE v.3 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCTCAE v.3 View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCTCAE v.3 View
Hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCTCAE v.3 View
Hypertension SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCTCAE v.3 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCTCAE v.3 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCTCAE v.3 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders NCTCAE v.3 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCTCAE v.3 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCTCAE v.3 View
Infection Gr0-2 neut, bronchus SYSTEMATIC_ASSESSMENT Infections and infestations NCTCAE v.3 View
Infection Gr0-2 neut, sinus SYSTEMATIC_ASSESSMENT Infections and infestations NCTCAE v.3 View
Infection Gr0-2 neut, skin SYSTEMATIC_ASSESSMENT Infections and infestations NCTCAE v.3 View
Infection Gr0-2 neut, upper airway SYSTEMATIC_ASSESSMENT Infections and infestations NCTCAE v.3 View
Infection Gr0-2 neut, urinary tract SYSTEMATIC_ASSESSMENT Infections and infestations NCTCAE v.3 View
Infection w/unk ANC upper airway NOS SYSTEMATIC_ASSESSMENT Infections and infestations NCTCAE v.3 View
Infection-other SYSTEMATIC_ASSESSMENT Infections and infestations NCTCAE v.3 View
Insomnia SYSTEMATIC_ASSESSMENT General disorders NCTCAE v.3 View
irregular menses SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders NCTCAE v.3 View
joint, pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCTCAE v.3 View
joint-function SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCTCAE v.3 View
Leukocytes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCTCAE v.3 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders NCTCAE v.3 View
Metabolic/laboratory-other SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCTCAE v.3 View
Muco/stomatitis(symptom) oral cavity SYSTEMATIC_ASSESSMENT Infections and infestations NCTCAE v.3 View
Muco/stomatitis by exam, oral cavity SYSTEMATIC_ASSESSMENT Infections and infestations NCTCAE v.3 View
Muscle, pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCTCAE v.3 View
Musculoskeletal/soft tissue-other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCTCAE v.3 View
Nail changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCTCAE v.3 View
Nasal cavity/paranasal sinus reaction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCTCAE v.3 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCTCAE v.3 View
Neck,pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCTCAE v.3 View
Neuropathy-sensory SYSTEMATIC_ASSESSMENT Nervous system disorders NCTCAE v.3 View
Neutrophils SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCTCAE v.3 View
Nonneuropathic generalized weakness SYSTEMATIC_ASSESSMENT General disorders NCTCAE v.3 View
Nose, hemorrhage SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCTCAE v.3 View
Oral cavity, hemorrhage SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCTCAE v.3 View
Oral gums, pain SYSTEMATIC_ASSESSMENT General disorders NCTCAE v.3 View
Pain NOS SYSTEMATIC_ASSESSMENT Nervous system disorders NCTCAE v.3 View
Pain-other SYSTEMATIC_ASSESSMENT Nervous system disorders NCTCAE v.3 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders NCTCAE v.3 View
Platelets SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCTCAE v.3 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCTCAE v.3 View
Pruritus/itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCTCAE v.3 View
Pulmonary/upper respiratory-other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCTCAE v.3 View
Radiation dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCTCAE v.3 View
Rash/desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCTCAE v.3 View
Rash: acne/acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCTCAE v.3 View
Rectum, hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCTCAE v.3 View
Rigors/chills SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCTCAE v.3 View
Skin-other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Taste disturbance SYSTEMATIC_ASSESSMENT General disorders NCTCAE V3 View
Tearing SYSTEMATIC_ASSESSMENT Eye disorders NCTCAE V3 View
Throat/Pharynx/larynx,pain SYSTEMATIC_ASSESSMENT General disorders NCTCAE V3 View
Vagina, hemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders NCTCAE V3 View
Vaginal discharge (non-infectious) SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders NCTCAE V3 View
Vaginal dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders NCTCAE V3 View
Vision-blurred SYSTEMATIC_ASSESSMENT Eye disorders NCTCAE V3 View
Voice changes/dysarthria SYSTEMATIC_ASSESSMENT General disorders NCTCAE V3 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCTCAE V3 View
Weight Gain SYSTEMATIC_ASSESSMENT General disorders NCTCAE V3 View
Wound-non-infectious SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCTCAE V3 View
Cardiac-other SYSTEMATIC_ASSESSMENT Cardiac disorders NCTCAE V3 View
bruising SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCTCAE v.3 View
buttock, pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCTCAE v.3 View
Chelitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCTCAE v.3 View
chest wall, pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCTCAE v.3 View
Chest/thoracic pain NOS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCTCAE v.3 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCTCAE v.3 View
Constitutional, other SYSTEMATIC_ASSESSMENT General disorders NCTCAE v.3 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCTCAE v.3 View
creatinine SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCTCAE v.3 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders NCTCAE v.3 View
Diarrhea w/o prior colostomy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCTCAE v.3 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders NCTCAE v.3 View
Dry Eye Syndrome SYSTEMATIC_ASSESSMENT Eye disorders NCTCAE v.3 View
Dry Mouth SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCTCAE v.3 View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCTCAE v.3 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCTCAE v.3 View
breast,pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCTCAE v.3 View