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 @ 5:03 PM
Ignite Modification Date: 2025-12-25 @ 2:43 PM
NCT ID: NCT00261950
Description: The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Frequency Threshold: 5
Time Frame: 52 weeks
Study: NCT00261950
Study Brief: Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cinacalcet cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information. None None 45 110 84 110 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Mitral valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Hyperparathyroidism secondary SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 14.0 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.0 View
Papilloedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Colitis ischaemic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Gastritis haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Pancreatitis chronic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Bile duct obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Acinetobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Breast abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Escherichia bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Escherichia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Infected skin ulcer SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Coronary artery restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Delayed recovery from anaesthesia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Post procedural discharge SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Traumatic brain injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Diabetic foot SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Systemic lupus erythematosus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Hypoxic-ischaemic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Depression suicidal SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Renal pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Arterial disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Arteriovenous fistula SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Intra-abdominal haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Peripheral vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Impaired healing SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Vascular pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View