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 @ 12:21 AM
Ignite Modification Date: 2025-12-25 @ 10:25 PM
NCT ID: NCT02018458
Description: Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
Frequency Threshold: 0
Time Frame: Up to 4 years
Study: NCT02018458
Study Brief: Safety Study Of Chemotherapy Combined With Dendritic Cell Vaccine to Treat 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
LA TNBC: DC Vaccine+Preop Chemo LA TNBC patients will be enrolled to receive DC vaccinations during the 24 weeks of standard preoperative dose-dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel and carboplatin (TCb) chemotherapy. 4 None 3 10 10 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Right atrial thrombosis SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v4.03 View
cellulitis of right breast SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v4.03 View
dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.03 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.03 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Right breast focal fibrosis with fat necrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v4.03 View
Numbness of feet SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v4.03 View
Fungal infection left great toe SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.03 View
Seroma bilateral breast SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v4.03 View
Redness Right Breast SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v4.03 View
Sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.03 View
Left big toe brittle nail SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v4.03 View
Right upper extremity lymphedema SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTCAE v4.03 View
Pain SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.03 View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v4.03 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v4.03 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.03 View
Dehydration SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.03 View
Dizziness SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.03 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTCAE v4.03 View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v4.03 View
Intermittent Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v4.03 View
Herpes Genitalis SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.03 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE v4.03 View
Pain Right Shoulder SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.03 View
Vibrating Apheresis SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.03 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v4.03 View
Mouth Sores SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.03 View
Insect Bite SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.03 View
Mastalgia right breast SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v4.03 View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v4.03 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders NCI CTCAE v4.03 View
Arthralgias SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v4.03 View
Hypovitaminosis SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.03 View
Chemo induced nails bruised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v4.03 View
Neuropathy bilateral lower extremity SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v4.03 View
Tenderness of lymph nodes in right armpit SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v4.03 View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v4.03 View
Joint popping in hands SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v4.03 View
Neuropathy in hands and feet SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v4.03 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.03 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.03 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.03 View
DVT LLE SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTCAE v4.03 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.03 View
Shortness of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.03 View
Intermittent Neuropathy in Toes SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v4.03 View
Sore Throat SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.03 View
Lower Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v4.03 View
Epistaxis SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTCAE v4.03 View
Sleep Disturbance SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.03 View
Peripheral Neuropathy hands and feet SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v4.03 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v4.03 View
Seroma Left Axilla SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v4.03 View
Upper Abdomen Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.03 View
Blurred Vision SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.03 View
Tingling of the Tongue SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v4.03 View
Peripheral Neuropathy arms and hands SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v4.03 View
Peripheral Neuropathy bilateral feet SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v4.03 View
flutter in chest SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v4.03 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.03 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE v4.03 View
UTI SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTCAE v4.03 View
Fever SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.03 View
Headache SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.03 View
Chills SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.03 View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.03 View
Oral Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.03 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.03 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.03 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.03 View
Parageusia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.03 View
Pruritus SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.03 View
Venous Access Failure SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.03 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v4.03 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v4.03 View
Right Axilla Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v4.03 View
Right breast cellulitis post reconstruction/expanders surgery SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v4.03 View
Weight loss SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.03 View
Gastroesophageal Reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.03 View
Hot Flashes SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.03 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v4.03 View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.03 View
Nodule Left Arm SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v4.03 View
Tingling SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v4.03 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.03 View
Osteopenia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v4.03 View