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 @ 7:23 PM
Ignite Modification Date: 2025-12-25 @ 5:03 PM
NCT ID: NCT02834403
Description: None
Frequency Threshold: 0
Time Frame: From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
Study: NCT02834403
Study Brief: L-NMMA Plus Taxane Chemotherapy in Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental: L-NMMA 12.5 mg/kg and Docetaxel 75 mg/m2 Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 12.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1. 0 None 0 2 2 2 View
Experimental: L-NMMA 15 mg/kg and Docetaxel 75 mg/m2 Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 15 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1. 0 None 0 2 1 2 View
Experimental: L-NMMA 17.5 mg/kg and Docetaxel 100 mg/m2 Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 17.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1. 0 None 1 3 3 3 View
Experimental: L-NMMA 20 mg/kg and Docetaxel 100 mg/m2 Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 20 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1. 0 None 1 4 4 4 View
Experimental: Phase II: RP2D Determined in the Phase Ib Phase II: L-NMMA starting dose will be the RP2D determined in the Phase Ib portion of the study 0 None 3 20 17 20 View
Experimental: L-NMMA 10 mg/kg and Docetaxel 75 mg/m2 Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 10 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1. 0 None 2 2 2 2 View
Experimental: L-NMMA 7.5 mg/kg and Docetaxel 75 mg/m2 Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 7.5 mg/kg (starting dose) will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1. Amlodipine: Long-acting calcium channel blocker Pegfilgrastim: Colony-stimulating factor Enteric-coated aspirin: non-steroidal anti-inflammatory drug 0 None 1 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Change in mental status SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Right upper extremity Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Acute renal insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Chest wall significant Erythema on front and back SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Clinical sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bicytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bilateral Leg Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema SYSTEMATIC_ASSESSMENT General disorders None View
Elevated AST and ALT SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue and weakness SYSTEMATIC_ASSESSMENT General disorders None View
Gum bleeding SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hand-foot Syndrome SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Arm and shoulder swelling SYSTEMATIC_ASSESSMENT General disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lower abdomen incision packing SYSTEMATIC_ASSESSMENT General disorders None View
Narrowing of brachiocephalic vein stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral mucositis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Rosacea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sensitivity to light SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Transaminitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Decreased Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Body Aches SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Contusion SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View