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 @ 4:01 PM
Ignite Modification Date: 2025-12-25 @ 2:04 PM
NCT ID: NCT00436566
Description: Adverse event data is not available on one patient, thus, only 108 patients were included in adverse events table.
Frequency Threshold: 0
Time Frame: None
Study: NCT00436566
Study Brief: Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AC/PTL Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m\^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months. None None 17 108 107 108 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Leukopenia SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Lymph node pain SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Diastolic dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 9 View
Middle ear inflammation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 9 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Vision SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Vision-Blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Watering eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Anal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Oral cavity Mucositis/stomatitis (clinical exam) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Constitutional Symptoms SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Influenza Symptoms SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Pain-Chest SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 9 View
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Bronchial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Clostridial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Dental-tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Infection without neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Mucosa infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Opportunisitic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Sinus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Skin (cellulites) infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Stomach infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Upper airway infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Appendix injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Dermatitis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Leukopenia SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Joint effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Muscle Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Sinus pain SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Taste SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Bladder spasm SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Glomerular filtration rate SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Urethra Hemorrhage SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Vaginal inflammation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Dermatology SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Hand-foot skin reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Nail Changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View