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 @ 11:54 PM
Ignite Modification Date: 2025-12-25 @ 9:50 PM
NCT ID: NCT00191451
Description: Adverse events are provided for all patients who received at least one dose of study drug. Adverse events represent all grades (I-IV).
Frequency Threshold: 5
Time Frame: None
Study: NCT00191451
Study Brief: A Study of Gemcitabine and Carboplatin (Plus Herceptin in Human Epidermal Growth Factor Receptor 2 Positive [HER2+] Patients) With Metastatic 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
HER2+ Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin. Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion). None None 10 50 50 50 View
HER2- (Taxane-) Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). None None 11 48 48 48 View
HER2- (Taxane+) Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). None None 10 47 45 47 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11 View
Diastolic dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11 View
Oesophageal spasm SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11 View
Retching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 11 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11 View
Mucous membrane disorder SYSTEMATIC_ASSESSMENT General disorders MedDRA 11 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11 View
Haemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11 View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11 View
Breast cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11 View
Intracranial hypotension SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11 View
Neurological symptom SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11 View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11 View
Lung infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11 View
Orthopnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11 View
Vena cava thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 11 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 11 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11 View
Catheter sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11 View
Fungaemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 11 View
Localised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 11 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 11 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 11 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 11 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 11 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 11 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 11 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11 View
Alanine aminotransferase SYSTEMATIC_ASSESSMENT Investigations MedDRA 11 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11 View
Aspartate aminotransferase SYSTEMATIC_ASSESSMENT Investigations MedDRA 11 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11 View
Blood alkaline phosphatase SYSTEMATIC_ASSESSMENT Investigations MedDRA 11 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11 View
Blood calcium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11 View
Haemoglobin SYSTEMATIC_ASSESSMENT Investigations MedDRA 11 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11 View
Neutrophil count SYSTEMATIC_ASSESSMENT Investigations MedDRA 11 View
Platelet count SYSTEMATIC_ASSESSMENT Investigations MedDRA 11 View
Platelet count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11 View
White blood cell count SYSTEMATIC_ASSESSMENT Investigations MedDRA 11 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11 View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11 View
Paranasal sinus hypersecretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11 View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11 View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11 View