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 @ 5:04 PM
Ignite Modification Date: 2025-12-25 @ 2:44 PM
NCT ID: NCT00104650
Description: The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Frequency Threshold: 5
Time Frame: 25 weeks
Study: NCT00104650
Study Brief: Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bisphosphonate IV Q4W None None None 19 35 33 35 View
Denosumab 180 mg Q12W None None None 16 35 29 35 View
Denosumab 180 mg Q4W None None None 21 38 29 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Bone marrow failure SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Obstruction SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
Hepatomegaly SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Urinary tract infection staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Brain contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Cachexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Metastases to bone SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Metastases to central nervous system SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Metastases to liver SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Metastases to lung SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Metastases to meninges SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Metastasis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Multiple myeloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Prostate cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Epiduritis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Facial paresis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Kidney enlargement SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Renal tubular necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Scar SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Radiotherapy to bone SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 10.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Neurogenic shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Cholangitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Vaginal cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Areflexia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Metastases to liver SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Gynaecomastia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.0 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Radiotherapy to bone SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 10.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 10.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View