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 @ 7:45 PM
Ignite Modification Date: 2025-12-25 @ 5:22 PM
NCT ID: NCT04205903
Description: None
Frequency Threshold: 5
Time Frame: Up to 6 weeks
Study: NCT04205903
Study Brief: Nilotinib in Preventing Paclitaxel-Induced Peripheral Neuropathy in Patients With Stage I-III 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
Dose Level 3 Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Nilotinib: Given PO Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15. Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2 Questionnaire Administration: Ancillary studies 0 None 0 2 2 2 View
Dose Level 1 Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Nilotinib: Given PO Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15. Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2 Questionnaire Administration: Ancillary studies 0 None 0 5 5 5 View
Dose Level 2 Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Nilotinib: Given PO Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15. Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2 Questionnaire Administration: Ancillary studies 0 None 2 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.5.0 View
Cardiac disorders - Other, specify SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Ear and labyrinth disorders - Other, specify SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE v.5.0 View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Watering eyes SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Nervous system disorders - Other, specify SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Bullous dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Nail changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Palmar-plantar erythrodysesthesia syndrome 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
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Joint range of motion decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Muscle cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Scoliosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Extrapyramidal disorder SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Sleep apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Injury, poisoning and procedural complications - Other, specify SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Musculoskeletal and connective tissue disorder - Other, specify SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Pruritus 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
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE v.5.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Breast infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View