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 @ 5:23 PM
Ignite Modification Date: 2025-12-25 @ 2:58 PM
NCT ID: NCT03301350
Description: Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
Frequency Threshold: 0
Time Frame: 2 years from starting study treatment
Study: NCT03301350
Study Brief: Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in 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
Neoadjuvant Chemotherapy Regimen A (cycles 1-4): Paclitaxel 80 mg/m2; administer intravenously on day 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks) Carboplatin AUC=2 (dose calculation by determining creatine clearance with Cockroft Gault using adjusted body weight); administer intravenously on day 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks) Regimen B (cycles 5-8): Doxorubicin 60 mg/m2; administer intravenously on day 1 of cycles 5, 6, 7, 8 (every 2 weeks) Cyclophosphamide 600 mg/m2; administer intravenously on day 1 of cycles 5, 6, 7, 8 (every 2 weeks) Pegfilgrastim (for use on Doxorubicin/Cyclophosphamide cycles only), filgrastim, or biosimilar support on day 2 - 3 of cycles 5, 6, 7, 8 (every 2 weeks) There is a one week break between the end of cycle 4 and the beginning of cycle 5. Regimen C: Surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team. 3 None 17 28 10 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial fibrilation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Abdomincal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Enterocolitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fecal incontinence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Weight gain NON_SYSTEMATIC_ASSESSMENT Investigations None View
Weight loss NON_SYSTEMATIC_ASSESSMENT Investigations None View
Electrocardiogram QT corrected interval prolonged NON_SYSTEMATIC_ASSESSMENT Investigations None View
INR increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Edema limbs NON_SYSTEMATIC_ASSESSMENT General disorders None View
Localized edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Edema face NON_SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Generalized edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral motor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nail discoloration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nail changes NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin hyperpigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nail loss NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nail ridging NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Palmar-plantar erythrodysesthesia syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin and subcutaneous tissue disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Generalized muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal and connective tissue disorder - Other, specify NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Postnasal drip NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hoarseness NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hot flashes NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nail infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Thrush NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Conjunctivitis infective NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Enterocolitis infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Eye infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blurred vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjuntivitis infective NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Supraventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hemoglobinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Breast pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Menorrhagia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Bilirubin increased NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thromboembolic event NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Folliculitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View