Adverse Events Module

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: 2025-12-25 @ 3:21 AM
Ignite Modification Date: 2025-12-26 @ 1:59 AM
NCT ID: NCT00365105
Description: Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Frequency Threshold: 5
Time Frame: None
Study: NCT00365105
Study Brief: Zoledronate, Vitamin D, and Calcium With or Without Strontium 89 or Samarium 153 in Preventing or Delaying Bone Problems in Patients With Bone Metastases From Prostate Cancer, Lung Cancer, or 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
Zoledronic Acid Zoledronic acid, vitamin D and calcium supplements. None None 31 123 102 123 View
Zoledronic Acid + Radiopharmaceuticals Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153. None None 37 124 108 124 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Blood/bone marrow - Other: NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Hemoglobin NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Cardiac General - Other: NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Myocardial ischaemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Sick Sinus Syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Sinus bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Supraventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Diplopia NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Abdominal pain NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Colonic obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Colonic perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Diarrhoea NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Duodenal ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Gastric haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Gastrointestinal - Other: NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Ileal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Lower gastrointestinal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Rectal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Small intestinal stricture NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Vomiting NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Death NOS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Disease progression NOS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Edema: limb: NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Gait abnormal NOS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain NOS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Abdominal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Bladder infection NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Bone infection NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Bronchitis NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Infection - Other: NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Bladder (urinary) NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Catheter-related NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Lung (pneumonia) NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Pleura (empyema) NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Infection with unknown ANC: Urinary tract NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Pneumonia NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Sepsis NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Fracture NOS NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Activated partial thromboplastin time prolonged NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Leukopenia NOS NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Metabolic/laboratory - Other: NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Neutrophil count NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Prothrombin time prolonged NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Troponin T increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypercalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hyperglycaemia NOS NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Chest wall pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Muscle weakness NOS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Osteonecrosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Osteoporosis NOS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Cancer pain NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (3.0) View
Ataxia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Cerebral ischaemia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Depressed level of consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Neurology - Other: NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Bladder obstruction NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Renal failure NOS NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Renal/genitourinary - Other: NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Urethral obstruction NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Acute respiratory distress syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Hypotension NOS NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Peripheral motor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Syncope vasovagal NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Pneumonitis NOS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Pulmonary/upper respiratory - Other: NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Ulceration: NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemoglobin NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Vomiting NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Disease progression NOS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Edema: limb: NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain - Other: NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain NOS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pneumonia NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Respiratory tract infection NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Ecchymosis NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Fracture NOS NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Leukopenia NOS NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Neutrophil count NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypercalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hyperglycaemia NOS NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Arthritis NOS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Muscle weakness NOS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Musculoskeletal/soft tissue - Other: NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Pollakiuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Renal/genitourinary - Other: NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Pelvic pain NOS NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Pulmonary/upper respiratory - Other: NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Dermatitis exfoliative NOS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Dermatology/skin - Other: NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Localised exfoliation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Hot flushes NOS NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Hypertension NOS NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Hypotension NOS NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Ocular/visual - Other: NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Abdominal pain NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Diarrhoea NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Peripheral motor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View