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 @ 3:34 PM
Ignite Modification Date: 2025-12-25 @ 1:47 PM
NCT ID: NCT00661492
Description: For treated patients only, assessed at each treatment visit
Frequency Threshold: 5
Time Frame: During the whole treatment period, up to 30 days following last dose
Study: NCT00661492
Study Brief: Mitoxantrone ± Cetuximab 2nd Line Androgen Independent Prostate Cancer (AIPC)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 1 Novantrone+Erbitux None None 39 75 74 75 View
Arm 2 Novantrone None None 12 39 39 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ACCIDENT CEREBROVASCULAR SYSTEMATIC_ASSESSMENT Vascular disorders COSTART, CTCAE 3.0 View
ALLERGIC REACTION SYSTEMATIC_ASSESSMENT Immune system disorders COSTART, CTCAE 3.0 View
ANEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders COSTART, CTCAE 3.0 View
ANOREXIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
BELL'S PALSY SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART, CTCAE 3.0 View
CARDIAC ARREST SYSTEMATIC_ASSESSMENT Vascular disorders COSTART, CTCAE 3.0 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations COSTART, CTCAE 3.0 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders COSTART, CTCAE 3.0 View
CHILLS SYSTEMATIC_ASSESSMENT General disorders COSTART, CTCAE 3.0 View
CONFUSION SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART, CTCAE 3.0 View
CONGESTIVE HEART FAILURE SYSTEMATIC_ASSESSMENT Vascular disorders COSTART, CTCAE 3.0 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
DIARRHEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
DISTRESS RESPIRATORY SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART, CTCAE 3.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART, CTCAE 3.0 View
EDEMA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders COSTART, CTCAE 3.0 View
EFFUSION PLEURAL SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART, CTCAE 3.0 View
EMBOLISM PULMONARY SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART, CTCAE 3.0 View
EMBOLUS PULMONARY SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART, CTCAE 3.0 View
FEBRILE NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders COSTART, CTCAE 3.0 View
FEVER SYSTEMATIC_ASSESSMENT Infections and infestations COSTART, CTCAE 3.0 View
BRAIN METASTASES SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) COSTART, CTCAE 3.0 View
DEATH SUDDEN (NOS) SYSTEMATIC_ASSESSMENT Investigations COSTART, CTCAE 3.0 View
DISEASE PROGRESSION SYSTEMATIC_ASSESSMENT Investigations COSTART, CTCAE 3.0 View
FIBRILLATION ATRIAL SYSTEMATIC_ASSESSMENT Cardiac disorders COSTART, CTCAE 3.0 View
FLUTTER ATRIAL SYSTEMATIC_ASSESSMENT Cardiac disorders COSTART, CTCAE 3.0 View
FRACTURE PATHOLOGICAL SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders COSTART, CTCAE 3.0 View
GASTROINTESTINAL BLEEDING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
GI HEMORRHAGE SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders COSTART, CTCAE 3.0 View
HEMATURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders COSTART, CTCAE 3.0 View
HYDRONEPHROSIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders COSTART, CTCAE 3.0 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders COSTART, CTCAE 3.0 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders COSTART, CTCAE 3.0 View
INFECTION BACTERIAL SYSTEMATIC_ASSESSMENT Infections and infestations COSTART, CTCAE 3.0 View
INFECTION BLADDER SYSTEMATIC_ASSESSMENT Infections and infestations COSTART, CTCAE 3.0 View
INFECTION VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations COSTART, CTCAE 3.0 View
ISCHEMIA MYOCARDIAL SYSTEMATIC_ASSESSMENT Cardiac disorders COSTART, CTCAE 3.0 View
MENTAL DEFICIENCY SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART, CTCAE 3.0 View
MENTAL DETERIORATION SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART, CTCAE 3.0 View
MOOD ALTERED SYSTEMATIC_ASSESSMENT Psychiatric disorders COSTART, CTCAE 3.0 View
MULTIPLE ORGAN FAILURE SYSTEMATIC_ASSESSMENT General disorders COSTART, CTCAE 3.0 View
MUSCLE WEAKNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders COSTART, CTCAE 3.0 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders COSTART, CTCAE 3.0 View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders COSTART, CTCAE 3.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders COSTART, CTCAE 3.0 View
NOSEBLEED SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders COSTART, CTCAE 3.0 View
PAIN SYSTEMATIC_ASSESSMENT General disorders COSTART, CTCAE 3.0 View
PAIN BACK SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders COSTART, CTCAE 3.0 View
PAIN PELVIC SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders COSTART, CTCAE 3.0 View
PAIN SACROILIAC SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders COSTART, CTCAE 3.0 View
PHLEBITIS SYSTEMATIC_ASSESSMENT Vascular disorders COSTART, CTCAE 3.0 View
PLEURAL EFFUSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART, CTCAE 3.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART, CTCAE 3.0 View
PROSTATIC DISORDER SYSTEMATIC_ASSESSMENT Endocrine disorders COSTART, CTCAE 3.0 View
RECTAL BLEEDING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
RECTAL DISORDER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
RECTAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
RENAL FAILURE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART, CTCAE 3.0 View
SHORTNESS OF BREATH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART, CTCAE 3.0 View
SPINAL CORD COMPRESSION SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders COSTART, CTCAE 3.0 View
STROKE SYSTEMATIC_ASSESSMENT Vascular disorders COSTART, CTCAE 3.0 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART, CTCAE 3.0 View
TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders COSTART, CTCAE 3.0 View
THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders COSTART, CTCAE 3.0 View
TRACHEOBRONCHITIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART, CTCAE 3.0 View
URINARY BLADDER OBSTRUCTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders COSTART, CTCAE 3.0 View
URINARY INCONTINENCE SYSTEMATIC_ASSESSMENT Renal and urinary disorders COSTART, CTCAE 3.0 View
URINARY RETENTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders COSTART, CTCAE 3.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
WEAKNESS SYSTEMATIC_ASSESSMENT General disorders COSTART, CTCAE 3.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
DIARRHEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
EDEMA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders COSTART, CTCAE 3.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART, CTCAE 3.0 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders COSTART, CTCAE 3.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART, CTCAE 3.0 View
SHORTNESS OF BREATH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART, CTCAE 3.0 View
INFECTION BACTERIAL SYSTEMATIC_ASSESSMENT Infections and infestations COSTART, CTCAE 3.0 View
PAIN BACK SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders COSTART, CTCAE 3.0 View
MUCOSITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
WEAKNESS SYSTEMATIC_ASSESSMENT General disorders COSTART, CTCAE 3.0 View
FEVER SYSTEMATIC_ASSESSMENT Infections and infestations COSTART, CTCAE 3.0 View
GASTROESOPHAGEAL REFLUX SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
ALLERGIC REACTION SYSTEMATIC_ASSESSMENT Immune system disorders COSTART, CTCAE 3.0 View
HYPERGLYCEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders COSTART, CTCAE 3.0 View
INFECTION UPPER RESPIRATORY SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART, CTCAE 3.0 View
INSOMNIA SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART, CTCAE 3.0 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders COSTART, CTCAE 3.0 View
WEIGHT LOSS SYSTEMATIC_ASSESSMENT General disorders COSTART, CTCAE 3.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART, CTCAE 3.0 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
NEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART, CTCAE 3.0 View
HEMATURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders COSTART, CTCAE 3.0 View
HYPOCALCEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders COSTART, CTCAE 3.0 View
CHILLS SYSTEMATIC_ASSESSMENT General disorders COSTART, CTCAE 3.0 View
CONJUNCTIVITIS SYSTEMATIC_ASSESSMENT Eye disorders COSTART, CTCAE 3.0 View
INFECTION FUNGAL SYSTEMATIC_ASSESSMENT Infections and infestations COSTART, CTCAE 3.0 View
LYMPHOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders COSTART, CTCAE 3.0 View
MUSCLE WEAKNESS SYSTEMATIC_ASSESSMENT General disorders COSTART, CTCAE 3.0 View
NAIL DISORDER SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders COSTART, CTCAE 3.0 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
ALKALINE PHOSPHASTASE SERUM INCREASE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders COSTART, CTCAE 3.0 View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders COSTART, CTCAE 3.0 View
INFECTION BLADDER SYSTEMATIC_ASSESSMENT Infections and infestations COSTART, CTCAE 3.0 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations COSTART, CTCAE 3.0 View
URINARY URGENCY/FREQUENCY SYSTEMATIC_ASSESSMENT Renal and urinary disorders COSTART, CTCAE 3.0 View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders COSTART, CTCAE 3.0 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders COSTART, CTCAE 3.0 View
EPIPHORA SYSTEMATIC_ASSESSMENT Eye disorders COSTART, CTCAE 3.0 View
GLUCOSE BLOOD INCREASED SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders COSTART, CTCAE 3.0 View
PHARYNGITIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART, CTCAE 3.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders COSTART, CTCAE 3.0 View
ALT INCREASED SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders COSTART, CTCAE 3.0 View
AST INCREASED SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders COSTART, CTCAE 3.0 View
CREATININE SERUM INCREASED SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders COSTART, CTCAE 3.0 View
SHOULDER PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders COSTART, CTCAE 3.0 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders COSTART, CTCAE 3.0 View
THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders COSTART, CTCAE 3.0 View
CARDIAC INSUFFICIENCY SYSTEMATIC_ASSESSMENT Cardiac disorders COSTART, CTCAE 3.0 View
DYSGUESIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
HYPERKALEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders COSTART, CTCAE 3.0 View
RECTAL BLEEDING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
BRUISE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders COSTART, CTCAE 3.0 View
URINARY INCONTINENCE SYSTEMATIC_ASSESSMENT Renal and urinary disorders COSTART, CTCAE 3.0 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders COSTART, CTCAE 3.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders COSTART, CTCAE 3.0 View
LEUCOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders COSTART, CTCAE 3.0 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders COSTART, CTCAE 3.0 View
ANEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders COSTART, CTCAE 3.0 View
PAIN SYSTEMATIC_ASSESSMENT General disorders COSTART, CTCAE 3.0 View
HYPOMAGNESAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders COSTART, CTCAE 3.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
ANOREXIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART, CTCAE 3.0 View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders COSTART, CTCAE 3.0 View
DRY SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders COSTART, CTCAE 3.0 View