Adverse Events Module

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 @ 4:34 PM
Ignite Modification Date: 2025-12-25 @ 2:26 PM
NCT ID: NCT01525966
Description: All patients eligible for this study were graded for toxicities.
Frequency Threshold: 0
Time Frame: Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
Study: NCT01525966
Study Brief: Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative 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
Treatment (Carboplatin and Nab-paclitaxel) Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. carboplatin: Given IV paclitaxel albumin-stabilized nanoparticle formulation: Given IV 5 None 5 67 67 67 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
10016558-Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
10046571-Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
10012174-Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
10016288-Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
10042613-Surgical and medical procedures - Other, specify SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
10047848-Watering eyes SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
10008531-Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
10016256-Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
10016558-Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
10017577-Gait disturbance SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
10022095-Injection site reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
10033371-Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
10016778-Floaters SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
10002855-Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
10012378-Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
10022437-Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
10019450-Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
10036402-Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
10036790-Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
10020772-Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
10021097-Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
10047065-Vascular disorders - Other, specify SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
10014020-Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.0) View
10047340-Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.0) View
10065838-Middle ear inflammation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.0) View
10020705-Hyperparathyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (4.0) View
10020850-Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (4.0) View
10005886-Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
10010741-Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
10013774-Dry eye SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
10015919-Eye disorders - Other, specify SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
10015958-Eye pain SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
10016757-Flashing lights SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
10002272-Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
10016288-Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
10007541-Cardiac disorders - Other, specify SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
10019279-Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
10033557-Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
10040741-Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
10040752-Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
10061589-Aortic valve disease SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
10000060-Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
10000081-Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
10005265-Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
10010774-Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
10012727-Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
10013781-Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
10013946-Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
10013950-Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
10016766-Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
10017947-Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
10018286-Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
10028130-Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
10028813-Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
10030980-Oral hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
10031009-Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
10044055-Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
10047700-Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
10066874-Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
10050068-Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
10062466-Localized edema SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
10062501-Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
10001718-Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (4.0) View
10002218-Anaphylaxis SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (4.0) View
10007810-Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
10021881-Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
10040872-Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
10046300-Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
10046571-Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
10055078-Bronchial infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
10061304-Nail infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
10062255-Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
10065772-Vulval infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
10069138-Papulopustular rash SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
10006504-Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
10016173-Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
10048031-Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
10053692-Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
10061103-Dermatitis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
10001551-Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
10001675-Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
10003481-Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
10005364-Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
10007839-CD4 lymphocytes decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
10011368-Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
10025256-Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
10029366-Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
10035528-Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
10047896-Weight gain SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
10047900-Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
10049182-White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
10050528-Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
10002646-Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
10012174-Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
10020587-Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
10020639-Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
10020647-Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
10020670-Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
10020680-Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
10020870-Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
10020943-Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
10020949-Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
10021005-Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
10021018-Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
10021028-Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
10021038-Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
10021059-Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
10029883-Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
10003239-Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
10003988-Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
10006002-Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
10008496-Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
10016750-Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
10028411-Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
10028836-Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
10031282-Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
10033425-Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
10062572-Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
10065776-Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
10029104-Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (4.0) View
10045158-Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (4.0) View
10013573-Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
10013911-Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
10019211-Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
10027175-Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
10029205-Nervous system disorders - Other, specify SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
10029223-Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
10033987-Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
10034620-Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
10036653-Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
10044565-Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
10037032-Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
10046539-Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
10046543-Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
10046555-Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
10046593-Urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
10046628-Urine discoloration SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
10062225-Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
10006298-Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
10022992-Irregular menstruation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
10036601-Premature menopause SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
10046901-Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
10046904-Vaginal dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
10046912-Vaginal hemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
10001723-Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
10011224-Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
10013963-Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
10015090-Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
10028735-Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
10041232-Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
10041367-Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
10047924-Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
10001760-Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
10013786-Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
10020642-Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
10028691-Nail discoloration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
10037087-Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
10037847-Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
10037868-Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
10040785-Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
10040865-Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
10062283-Nail ridging SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
10027308-Menopause SYSTEMATIC_ASSESSMENT Social circumstances CTCAE (4.0) View
10041244-Social circumstances - Other, specify SYSTEMATIC_ASSESSMENT Social circumstances CTCAE (4.0) View
10016825-Flushing SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
10019428-Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
10020407-Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View