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: 2025-12-25 @ 4:26 AM
Ignite Modification Date: 2025-12-26 @ 3:30 AM
NCT ID: NCT00416520
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT00416520
Study Brief: A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MCI-196 (Open-label Period) 3, 6, 9, 12, or 15g/day as titrated None None 26 162 126 162 View
MCI-196 (Placebo-Controlled Period) dose level at the end of dose titration in the flexible dose period None None 2 50 20 50 View
Placebo (Placebo-Controlled Period) dose level at the end of dose titration in the flexible dose period None None 3 53 23 53 View
Sevelamer (Open-label Period) 2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated None None 25 169 113 169 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia None Blood and lymphatic system disorders None View
Acute coronary syndrome None Cardiac disorders None View
Angina pectoris None Cardiac disorders None View
Atrial fibrillation None Cardiac disorders None View
Atrioventricular block complete None Cardiac disorders None View
Cardiac arrest None Cardiac disorders None View
Cardiovascular insufficiency None Cardiac disorders None View
Congestive cardiomyopathy None Cardiac disorders None View
Coronary artery disease None Cardiac disorders None View
Coronary artery insufficiency None Cardiac disorders None View
Coronary artery stenosis None Cardiac disorders None View
Ischaemic cardiomyopathy None Cardiac disorders None View
Myocardial infarction None Cardiac disorders None View
Diverticulum intestinal None Gastrointestinal disorders None View
Duodenal ulcer haemorrhage None Gastrointestinal disorders None View
Catheter sepsis None Infections and infestations None View
Cellulitis None Infections and infestations None View
Genital haemorrhage None Reproductive system and breast disorders None View
Testicular pain None Reproductive system and breast disorders None View
Acute pulmonary oedema None Respiratory, thoracic and mediastinal disorders None View
Dyspnoea None Respiratory, thoracic and mediastinal disorders None View
Septic shock None Infections and infestations None View
Urinary tract infection None Infections and infestations None View
Arteriovenous fistula site complication None Injury, poisoning and procedural complications None View
Arteriovenous fistula site haemorrhage None Injury, poisoning and procedural complications None View
Arteriovenous fistula thrombosis None Injury, poisoning and procedural complications None View
Arteriogram coronary None Investigations None View
Hepatic enzyme increased None Investigations None View
Fluid overload None Metabolism and nutrition disorders None View
Fluid retention None Metabolism and nutrition disorders None View
Carotid artery stenosis None Nervous system disorders None View
Cerebrovascular disorder None Nervous system disorders None View
Benign prostatic hyperplasia None Reproductive system and breast disorders None View
Epistaxis None Respiratory, thoracic and mediastinal disorders None View
Cataract operation None Surgical and medical procedures None View
Coronary arterial stent insertion None Surgical and medical procedures None View
Renal transplant None Surgical and medical procedures None View
Toe amputation None Surgical and medical procedures None View
Circulatory collapse None Vascular disorders None View
Hypovolaemic shock None Vascular disorders None View
Peripheral vascular disorder None Vascular disorders None View
Pneumonia None Infections and infestations None View
Dialysis device complication None Injury, poisoning and procedural complications None View
Respiratory distress None Respiratory, thoracic and mediastinal disorders None View
Haemorrhoids None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Peritonitis None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Hernia None General disorders None View
Impaired healing None General disorders None View
Pyrexia None General disorders None View
Biliary colic None Hepatobiliary disorders None View
Cholelithiasis None Hepatobiliary disorders None View
Anaphylactic reaction None Immune system disorders None View
Bronchopneumonia None Infections and infestations None View
Diverticulitis None Infections and infestations None View
Fungal infection None Infections and infestations None View
Pyelonephritis acute None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Oropharyngeal pain None Respiratory, thoracic and mediastinal disorders None View
Anaemia None Blood and lymphatic system disorders None View
Angina pectoris None Cardiac disorders None View
Hyperparathyroidism None Endocrine disorders None View
Hyperparathyroidism secondary None Endocrine disorders None View
Eye haemorrhage None Eye disorders None View
Abdominal distension None Gastrointestinal disorders None View
Abdominal pain None Gastrointestinal disorders None View
Abdominal pain upper None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Diarrhoea None Gastrointestinal disorders None View
Duodenitis None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Eructation None Gastrointestinal disorders None View
Faeces discoloured None Gastrointestinal disorders None View
Flatulence None Gastrointestinal disorders None View
Frequent bowel movements None Gastrointestinal disorders None View
Gastritis None Gastrointestinal disorders None View
Haemorrhoids None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Asthenia None General disorders None View
Catheter site erythema None General disorders None View
Catheter site pain None General disorders None View
Chest pain None General disorders None View
Fatigue None General disorders None View
Non-cardiac chest pain None General disorders None View
Oedema peripheral None General disorders None View
Pyrexia None General disorders None View
Bronchitis None Infections and infestations None View
Bronchopneumonia None Infections and infestations None View
Cellulitis None Infections and infestations None View
Cystitis None Infections and infestations None View
Gastroenteritis None Infections and infestations None View
Influenza None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Pharyngitis None Infections and infestations None View
Respiratory tract infection 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
Arteriovenous fistula site complication None Injury, poisoning and procedural complications None View
Arteriovenous fistula thrombosis None Injury, poisoning and procedural complications None View
Haemodialysis-induced symptom None Injury, poisoning and procedural complications None View
Limb injury None Injury, poisoning and procedural complications None View
Procedural hypertension None Injury, poisoning and procedural complications None View
Procedural hypotension None Injury, poisoning and procedural complications None View
Blood parathyroid hormone increased None Investigations None View
C-reactive protein increased None Investigations None View
Electrocardiogram QT interval abnormal None Investigations None View
Haemoglobin decreased None Investigations None View
Decreased appetite None Metabolism and nutrition disorders None View
Fluid overload None Metabolism and nutrition disorders None View
Fluid retention None Metabolism and nutrition disorders None View
Hyperkalaemia None Metabolism and nutrition disorders None View
Hyperphosphataemia None Metabolism and nutrition disorders None View
Hypocalcaemia None Metabolism and nutrition disorders None View
Hypoglycaemia None Metabolism and nutrition disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Muscle spasms None Musculoskeletal and connective tissue disorders None View
Musculoskeletal pain None Musculoskeletal and connective tissue disorders None View
Pain in extremity None Musculoskeletal and connective tissue disorders None View
Headache None Nervous system disorders None View
Hypotonia None Nervous system disorders None View
Anxiety None Psychiatric disorders None View
Insomnia None Psychiatric disorders None View
Sleep disorder None Psychiatric disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Dyspnoea None Respiratory, thoracic and mediastinal disorders None View
Pleural effusion None Respiratory, thoracic and mediastinal disorders None View
Eczema None Skin and subcutaneous tissue disorders None View
Erythema None Skin and subcutaneous tissue disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Skin ulcer None Skin and subcutaneous tissue disorders None View
Renal transplant None Surgical and medical procedures None View
Hypertension None Vascular disorders None View
Hypotension None Vascular disorders None View
Lymphadenopathy None Blood and lymphatic system disorders None View
Spontaneous haematoma None Blood and lymphatic system disorders None View
Cardiac failure None Cardiac disorders None View
Sinus bradycardia None Cardiac disorders None View
Toothache None Gastrointestinal disorders None View
Bacteraemia None Infections and infestations None View
Catheter site infection None Infections and infestations None View
Rhinitis None Infections and infestations None View
Tonsillitis None Infections and infestations None View
Arteriovenous fistula site haemorrhage None Injury, poisoning and procedural complications None View
Eschar None Injury, poisoning and procedural complications None View
Blood phosphorus decreased None Investigations None View
Gamma-glutamyltransferase increased None Investigations None View
Vitamin D decreased None Investigations None View
Weight increased None Investigations None View
Acidosis None Metabolism and nutrition disorders None View
Metabolic acidosis None Metabolism and nutrition disorders None View
Cervical spinal stenosis None Musculoskeletal and connective tissue disorders None View
Osteoarthritis None Musculoskeletal and connective tissue disorders None View
Osteonecrosis None Musculoskeletal and connective tissue disorders None View
Restless legs syndrome None Nervous system disorders None View
Haematuria None Renal and urinary disorders None View
Chronic obstructive pulmonary disease None Respiratory, thoracic and mediastinal disorders None View
Pharyngeal erythema None Respiratory, thoracic and mediastinal disorders None View
Dry skin None Skin and subcutaneous tissue disorders None View