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 @ 12:43 PM
Ignite Modification Date: 2025-12-25 @ 12:13 PM
NCT ID: NCT03602261
Description: Safety population. CTAP101 group has 32 subjects and placebo group has 11 subjects who received at least 1 dose.
Frequency Threshold: 0
Time Frame: 26 weeks
Study: NCT03602261
Study Brief: Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CTAP101 Capsules 900mcg/Weekly CTAP101 Oral Capsules/Calcifediol, calcidiol, 25-hydroxyvitamin D3, 900mcg/weekly for 26 weeks Calcifediol Oral Capsule: Capsule, weekly 0 None 15 32 29 32 View
Placebo Capsules Weekly Placebo Oral Capsules/weekly for 26 weeks Placebo oral capsule: Capsule, weekly 0 None 4 11 9 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Corona virus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic embolus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Demyelinating polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paraplegia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arteriovenous fistula site haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Arteriovenous fistula thrombosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Incision site complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bundle branch block right SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiomegaly SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Faeces discoloured SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal angiectasia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Jejunal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Feeling abnormal SYSTEMATIC_ASSESSMENT General disorders None View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders None View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders None View
Localised oedema SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infectious colitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tracheobronchitis viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Arteriovenous fistula thrombosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Bone contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Complications of transplant surgery SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post-traumatic pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural hypotension SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular access malfunction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Breath sounds abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Coronavirus test positive SYSTEMATIC_ASSESSMENT Investigations None View
Intraocular pressure test SYSTEMATIC_ASSESSMENT Investigations None View
Troponin increased SYSTEMATIC_ASSESSMENT Investigations None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Benign neoplasm of thyroid gland SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Carotid artery occlusion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
IIIrd nerve paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Unresponsive to stimuli SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurogenic bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Breast oedema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary vascular disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rales SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertensive emergency SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Steal syndrome SYSTEMATIC_ASSESSMENT Vascular disorders None View