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 @ 9:26 PM
Ignite Modification Date: 2025-12-25 @ 7:12 PM
NCT ID: NCT00630032
Description: None
Frequency Threshold: 0
Time Frame: Throughtout the study, up to 5 years
Study: NCT00630032
Study Brief: Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis 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
Docetaxel 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks) Cyclophosphamide: 500 mg/m² every 3 weeks Docetaxel: 100 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks 58 None 207 398 398 398 View
Ixabepilone 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks); Cyclophosphamide: 500 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks Ixabepilone: 40 mg/m² every 3 weeks 51 None 158 364 364 364 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Aplasia bone marrow SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Febrile aplasia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Lymphocele SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Auricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Non ST segment elevation acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ear disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Cataract (left) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye infection SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Crohn's enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal obstruction complicating hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Epigastralgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Mucositis SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hepatic dysfunction NOS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NOS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis Escherichia coli SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Device complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Device failure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Device malfunction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Infection injection site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Thrombosis in device SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Abscess soft tissue SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscular pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain bone SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Chronic myeloid leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Colorectal adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Endometrial adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Gastric cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Malignant neoplasm of cardia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Myeloid leukemia, acute SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Ovarian carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Pulmonary carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Adenocarcinoma of the cervix SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Breast carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Breast ductal carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Carcinoma of tongue SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Ovarian cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Pancreas cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Pain nerve SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Schwannoma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebral hypoperfusion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Intercostal neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Melancholia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Infection urinary tract SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Exfoliative dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Fingernail discoloration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Recall phenomenon SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Allergic skin reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis bullous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Device implant NOS SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Abortion induced SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Jugular vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Thrombosis cerebral vein SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Cardiovascular disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cutaneous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Edema SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hepatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Mucitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Neurotoxicity peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sensory neurotoxicity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View