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 @ 5:58 PM
Ignite Modification Date: 2025-12-25 @ 3:20 PM
NCT ID: NCT02957968
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was collected from time of study registration until 30 days following the last dose of decitabine, or until another cancer treatment was initiated, or 30 days following surgery, 12- months.
Study: NCT02957968
Study Brief: Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort A: Triple Negative Breast Cancer (TNBC) Triple Negative Breast Cancer (Cohort A): Decitabine IV over 60 minutes on 4 days and pembrolizumab IV over 30 minutes on days 8 and 22. Four cycles of dose-dense doxorubicin and cyclophosphamide (AC), followed by 12 doses of weekly paclitaxel and carboplatin. Doxorubicin: 60 mg/m2 once every 2 weeks for 4 cycles. Cyclophosphamide: cyclophosphamide 600 mg/m2 (AC) once every 2 weeks for 4 cycles. Paclitaxel: Paclitaxel 80 mg/m2 IV once weekly for 12 weeks. Carboplatin: carboplatin AUC 1.5 once weekly for 12 weeks. Decitabine: Given IV Pembrolizumab: Given IV 3 None 7 21 21 21 View
Cohort B: HER2-negative Hormone Receptor-positive Tumors HER2-negative hormone receptor-positive tumors (Cohort B): Decitabine IV over 60 minutes on 4 days and pembrolizumab IV over 30 minutes on days 8 and 22. Four cycles of dose-dense doxorubicin and cyclophosphamide (AC), followed by 12 doses of weekly paclitaxel. Doxorubicin: 60 mg/m2 once every 2 weeks for 4 cycles. Cyclophosphamide: cyclophosphamide 600 mg/m2 (AC) once every 2 weeks for 4 cycles. Paclitaxel: Paclitaxel 80 mg/m2 IV once weekly for 12 weeks. Decitabine: Given IV Pembrolizumab: Given IV 0 None 6 18 18 18 View
Cohort A2: Triple Negative Breast Cancer (TNBC) With Extended Pembrolizumab Triple Negative Breast Cancer (Cohort A2). Decitabine IV over 60 minutes on 4 days and pembrolizumab IV over 30 minutes on days 8 and 22. Four cycles of dose-dense doxorubicin and cyclophosphamide (AC), followed by 12 doses of weekly paclitaxel and carboplatin, and pembrolizumab every 3 weeks. Doxorubicin: 60 mg/m2 once every 2 weeks for 4 cycles. Cyclophosphamide: cyclophosphamide 600 mg/m2 (AC) once every 2 weeks for 4 cycles. Paclitaxel: Paclitaxel 80 mg/m2 IV once weekly for 12 weeks. Carboplatin: carboplatin AUC 1.5 once weekly for 12 weeks. Decitabine: Given IV Pembrolizumab: Given IV 0 None 4 7 7 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 5.0 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 5.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE v 5.0 View
Gallbladder Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 5.0 View
General Disorders and Administration Site Conditions- Other SYSTEMATIC_ASSESSMENT General disorders CTCAE v 5.0 View
Guillain-Barre syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 5.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 5.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 5.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 5.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v 5.0 View
Infections and Infestations- Other SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 5.0 View
Lung Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 5.0 View
Lipase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 5.0 View
Muscle Weakness Lower Limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 5.0 View
Adrenal Insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE v 5.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 5.0 View
Blood and Lymphatic System Disorders- Other SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 5.0 View
Catheter Related Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 5.0 View
Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 5.0 View
Vasculitis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v 5.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 5.0 View
Dental Caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 5.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 5.0 View
Disease Progression SYSTEMATIC_ASSESSMENT General disorders CTCAE v 5.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 5.0 View
Esophageal Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 5.0 View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 5.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 5.0 View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 5.0 View
Rash Maculo-Papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 5.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 5.0 View
Sinus Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v 5.0 View
Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v 5.0 View
Small Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 5.0 View
Thromboembolic Event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v 5.0 View
Tooth Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 5.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 5.0 View
Vascular Disorders- Other SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v 5.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gallbladder Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 5.0 View
Gastroesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 5.0 View
Gastrointestinal Disorders- Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 5.0 View
General Disorders Administration Site Conditions SYSTEMATIC_ASSESSMENT General disorders CTCAE v 5.0 View
Guillain-Barre Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 5.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 5.0 View
Hot Flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v 5.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 5.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v 5.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 5.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 5.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 5.0 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 5.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 5.0 View
Hypoparathyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE v 5.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v 5.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE v 5.0 View
Infections and infestations - Other SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 5.0 View
Injury, poisoning and procedural complications - Other SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v 5.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v 5.0 View
Investigations- Other SYSTEMATIC_ASSESSMENT Investigations CTCAE v 5.0 View
Lipase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 5.0 View
Lung Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 5.0 View
Lymphedema SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v 5.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 5.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders CTCAE v 5.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 5.0 View
Muscle Weakness Lower Limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 5.0 View
Muscle Weakness Right-Sided SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 5.0 View
Musculoskeletal and connective tissue disorder - Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 5.0 View
myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 5.0 View
Nail Changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 5.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 5.0 View
Neck Edema SYSTEMATIC_ASSESSMENT General disorders CTCAE v 5.0 View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 5.0 View
Nervous System Disorders- Other SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 5.0 View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 5.0 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v 5.0 View
Oral Dysesthesia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 5.0 View
Oral Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 5.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v 5.0 View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 5.0 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 5.0 View
Peripheral Motor Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 5.0 View
Peripheral Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 5.0 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v 5.0 View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 5.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 5.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 5.0 View
Rash Acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 5.0 View
Rash Maculo-Papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 5.0 View
Respiratory, thoracic and mediastinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 5.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 5.0 View
Sinus Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v 5.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 5.0 View
Skin and subcutaneous tissue disorders - Other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 5.0 View
Skin Hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 5.0 View
Skin Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 5.0 View
Small Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 5.0 View
Sore Throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 5.0 View
Thromboembolic Event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v 5.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE v 5.0 View
Tooth Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 5.0 View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE v 5.0 View
Urine Discoloration SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v 5.0 View
Vaccination Site Lymphadenopathy SYSTEMATIC_ASSESSMENT General disorders CTCAE v 5.0 View
Vaccination Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v 5.0 View
Vaginal Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 5.0 View
Vascular Access Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v 5.0 View
Vascular Disorders- Other SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v 5.0 View
Vasculitis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v 5.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 5.0 View
Weight Loss SYSTEMATIC_ASSESSMENT Investigations CTCAE v 5.0 View
White Blood Cell Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 5.0 View
Disease Progression SYSTEMATIC_ASSESSMENT General disorders CTCAE v 5.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 5.0 View
Dry Eye SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v 5.0 View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 5.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 5.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 5.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 5.0 View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE v 5.0 View
Edema Face SYSTEMATIC_ASSESSMENT General disorders CTCAE v 5.0 View
Edema Limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE v 5.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 5.0 View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 5.0 View
Esophageal Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 5.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v 5.0 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 5.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE v 5.0 View
Flu Like Symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE v 5.0 View
Gait Disturbance SYSTEMATIC_ASSESSMENT General disorders CTCAE v 5.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 5.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 5.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v 5.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 5.0 View
Asparate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 5.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 5.0 View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 5.0 View
Blood Bilirubin Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 5.0 View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 5.0 View
Breast Pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE v 5.0 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v 5.0 View
Cardiac Disorders-Other SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v 5.0 View
Catheter Related Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 5.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE v 5.0 View
Cholesterol High SYSTEMATIC_ASSESSMENT Investigations CTCAE v 5.0 View
Chronic Kidney Disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v 5.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 5.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 5.0 View
Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 5.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 5.0 View
Dental Carries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 5.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v 5.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 5.0 View
Adrenal Insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE v 5.0 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 5.0 View
Alkaline Phosphatase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v 5.0 View
Allergic Reaction SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE v 5.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 5.0 View
Allergic Rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 5.0 View