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 @ 7:59 PM
Ignite Modification Date: 2025-12-25 @ 5:33 PM
NCT ID: NCT01343004
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01343004
Study Brief: Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Teriparatide Blinded until after randomization, then open-label teriparatide: teriparatide 20 mcg subcutaneous daily None None 82 818 456 818 View
BA058 80 mcg (Abaloparatide) BA058 80 mcg: BA058 80 mcg subcutaneous daily None None 80 822 492 822 View
Placebo Placebo identical in appearance to BA058 study drug Placebo: Placebo 0 mcg subcutaneous daily None None 90 820 447 820 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infraction None Cardiac disorders None View
Abdominal pain None Gastrointestinal disorders None View
Colitis None Gastrointestinal disorders None View
Cholangitis None Hepatobiliary disorders None View
Femur fracture None Injury, poisoning and procedural complications None View
Fracture displacement None Injury, poisoning and procedural complications None View
Hand fracture None Injury, poisoning and procedural complications None View
Lower limb fracture None Injury, poisoning and procedural complications None View
Lumbar vertebral fracture None Injury, poisoning and procedural complications None View
Pancreatic neoplasm None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Invasive ductal breast carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pulmonary mass None Respiratory, thoracic and mediastinal disorders None View
Dermititis allergic None Skin and subcutaneous tissue disorders None View
Drug eruption None Skin and subcutaneous tissue disorders None View
Removal of internal fixation None Surgical and medical procedures None View
Toe operation None Surgical and medical procedures None View
Intermittent claudication None Vascular disorders None View
Anaemia None Blood and lymphatic system disorders None View
Myocardial ischaemia None Cardiac disorders None View
Supraventricular tachycardia None Cardiac disorders None View
Atrioventricular block None Cardiac disorders None View
Cardio-respiratory arrest None Cardiac disorders None View
Palpitations None Cardiac disorders None View
Acute coronary syndrome None Cardiac disorders None View
Acute myocardial infarction None Cardiac disorders None View
Angina pectoris None Cardiac disorders None View
Angina unstable None Cardiac disorders None View
Atrial fibrillation None Cardiac disorders None View
Cardiac failure congestive None Cardiac disorders None View
Cardiomyopathy None Cardiac disorders None View
Coronary artery stenosis None Cardiac disorders None View
Mitral valve stenosis None Cardiac disorders None View
Sinus bradycardia None Cardiac disorders None View
Vertigo None Ear and labyrinth disorders None View
Vestibular disorder None Ear and labyrinth disorders None View
Goitre None Endocrine disorders None View
Thyroid cyst None Endocrine disorders None View
Malculopathy None Eye disorders None View
Retinal artery occulusion None Eye disorders None View
Cataract None Eye disorders None View
Gastric Ulcer None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Duodenal ulcer None Gastrointestinal disorders None View
Haemorrhoids None Gastrointestinal disorders None View
Intestinal obstruction None Gastrointestinal disorders None View
Pancreatitis acute None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Change of bowel habit None Gastrointestinal disorders None View
Diverticulum None Gastrointestinal disorders None View
Enterocele None Gastrointestinal disorders None View
Gastric haemorrhage None Gastrointestinal disorders None View
Gastritis None Gastrointestinal disorders None View
Gastrointestinal haemorrhage None Gastrointestinal disorders None View
Inguinal hernia None Gastrointestinal disorders None View
Large intestine polyp None Gastrointestinal disorders None View
Chest pain None General disorders None View
Pyrexia None General disorders None View
Chest discomfort None General disorders None View
General physical health deterioration None General disorders None View
Sudden death None General disorders None View
Cholelithiasis None Hepatobiliary disorders None View
Bile duct stenosis None Hepatobiliary disorders None View
Biliary dyskinesia None Hepatobiliary disorders None View
Cholecystitis acute None Hepatobiliary disorders None View
Sepsis None Infections and infestations None View
Urinary tract infection None Infections and infestations None View
Appendicitis None Infections and infestations None View
Bronchiolitis None Infections and infestations None View
Bronchitis None Infections and infestations None View
Bronchopneumonia None Infections and infestations None View
Influenza None Infections and infestations None View
Pneumonia None Infections and infestations None View
Bacterial infection None Infections and infestations None View
Dengue fever None Infections and infestations None View
Gastroenteritis None Infections and infestations None View
Helicobacter infection None Infections and infestations None View
Localised infection None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Paronychia None Infections and infestations None View
Pyelonephritis acute None Infections and infestations None View
Respiratory tract infection None Infections and infestations None View
Viral infection None Infections and infestations None View
Craniocerebral injury None Injury, poisoning and procedural complications None View
Fibula fracture None Injury, poisoning and procedural complications None View
Humerus fracture None Injury, poisoning and procedural complications None View
Incisional hernia None Injury, poisoning and procedural complications None View
Joint dislocation None Injury, poisoning and procedural complications None View
Ligament rupture None Injury, poisoning and procedural complications None View
Patella fracture None Injury, poisoning and procedural complications None View
Postoperative hernia None Injury, poisoning and procedural complications None View
Spinal compression fracture None Injury, poisoning and procedural complications None View
Upper limb fracture None Injury, poisoning and procedural complications None View
Ankle fracture None Injury, poisoning and procedural complications None View
Contusion None Injury, poisoning and procedural complications None View
Extradural haematoma None Injury, poisoning and procedural complications None View
Meniscus injury None Injury, poisoning and procedural complications None View
Pelvic fracture None Injury, poisoning and procedural complications None View
Radius fracture None Injury, poisoning and procedural complications None View
Tibia fracture None Injury, poisoning and procedural complications None View
Ulna fracture None Injury, poisoning and procedural complications None View
Wrist fracture None Injury, poisoning and procedural complications None View
Weight decreased None Investigations None View
Blood glucose increased None Investigations None View
Body temperature increased None Investigations None View
Bronchoscopy None Investigations None View
Liver function test abnormal None Investigations None View
Hypoglycaemia None Metabolism and nutrition disorders None View
Hyperglycaemia None Metabolism and nutrition disorders None View
Gout None Metabolism and nutrition disorders None View
Hypercalcaemia None Metabolism and nutrition disorders None View
Osteoarthritis None Musculoskeletal and connective tissue disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Foot deformity None Musculoskeletal and connective tissue disorders None View
Spinal column stenosis None Musculoskeletal and connective tissue disorders None View
Spinal pain None Musculoskeletal and connective tissue disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Arthritis reactive None Musculoskeletal and connective tissue disorders None View
Lumbar spine stenosis None Musculoskeletal and connective tissue disorders None View
Spinal osteoarthritis None Musculoskeletal and connective tissue disorders None View
Spondylisthesis None Musculoskeletal and connective tissue disorders None View
Breast cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Adenocarcinoma of colon None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Breast cancer stage II None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Melanocytic naevus None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Adenocarcinoma gastric None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Angiolipoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Benign neoplasm of thyroid gland None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Bile duct adenocarcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Breast neoplasm None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Chronic leukaemia None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Gastric neoplasm None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Gastrointestinal carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung adenocarcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung neoplasm malignant None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Malignant melanoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Metastatic malignant melanoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Metastatic squamous cell carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Myeloproliferative disorder None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Uterine cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Transient ischaemic attack None Nervous system disorders None View
Depressed level of consciousness None Nervous system disorders None View
Hydrocephalus None Nervous system disorders None View
Intracranial aneurysm None Nervous system disorders None View
Radicular syndrome None Nervous system disorders None View
Sciatica None Nervous system disorders None View
Subarchnoid haemorrhage None Nervous system disorders None View
Syncope None Nervous system disorders None View
Tension headache None Nervous system disorders None View
Carpal tunnel syndrome None Nervous system disorders None View
Cerebrovascular accident None Nervous system disorders None View
Dizziness None Nervous system disorders None View
Ischaemic stroke None Nervous system disorders None View
Lacunar infarction None Nervous system disorders None View
Loss of consciousness None Nervous system disorders None View
VIIth nerve paralysis None Nervous system disorders None View
Hydronephrosis None Renal and urinary disorders None View
Calculus urinary None Renal and urinary disorders None View
Ovarian cyst None Reproductive system and breast disorders None View
Postmenopausal haemorrhage None Reproductive system and breast disorders None View
Uterine prolapse None Reproductive system and breast disorders None View
Cervical dysplasia None Reproductive system and breast disorders None View
Cystocele None Reproductive system and breast disorders None View
Uterine polyp None Reproductive system and breast disorders None View
Bronchiectasis None Respiratory, thoracic and mediastinal disorders None View
Dyspnoea None Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism None Respiratory, thoracic and mediastinal disorders None View
Sinus polyp None Respiratory, thoracic and mediastinal disorders None View
Allergic bronchitis None Respiratory, thoracic and mediastinal disorders None View
Hypersensitivity vasculitis None Skin and subcutaneous tissue disorders None View
Cholecystectomy None Surgical and medical procedures None View
Colporrhaphy None Surgical and medical procedures None View
Coronary angioplasty None Surgical and medical procedures None View
Hip arthroplasty None Surgical and medical procedures None View
Joint arthroplasty None Surgical and medical procedures None View
Knee arthroplasty None Surgical and medical procedures None View
Osteosynthesis None Surgical and medical procedures None View
Rectocele repair None Surgical and medical procedures None View
Aortic dissection None Vascular disorders None View
Essential hypertension None Vascular disorders None View
Hypertension None Vascular disorders None View
Hypertensive crisis None Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Palpitations None Cardiac disorders None View
Constipation None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Influenza None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Upper respiratory tract infection None Infections and infestations None View
Urinary tract infection None Infections and infestations None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Pain in extremity None Musculoskeletal and connective tissue disorders None View
Hypercalciuria None Renal and urinary disorders None View
Hypertension None Vascular disorders None View
Dizziness None Nervous system disorders None View
Headache None Nervous system disorders None View