Long-Term Therapy Outcomes When Treating Chronic Kidney D... | NCT01083849

Label	Type	Description	Intervention Names
Paricalcitol		Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.

Measure	Description	Time Frame
Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months	Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).	Up to 12 Months
Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months	Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).	Up to 12 months

Measure	Description	Time Frame
Number of Participants With Hypercalcemia	Hypercalcemia was defined as having a serum calcium level greater than 11.2 mg/dL (2.79 mmol/L), in one measurement. Serum calcium was measured at every study visit.	Months 0, 3, 6, 9, and 12
Number of Participants With Hyperphosphatemia

Name	Affiliation	Role
Sabine Decker-Burgard, MD	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site Reference ID/Investigator# 64522		Feldkirch		6800	Austria
Site Reference ID/Investigator# 53506

Label	URL
Related Info	View source

ID	Title	Description
FG000	Paricalcitol Pre-dialysis Group	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
FG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months

Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).

Participants with a determined chronic kidney disease (CKD) stage

Posted

Number

percentage of participants

Up to 12 Months

ID	Title	Description
OG000	Paricalcitol	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.

Units	Counts
Participants	OG000718

Title

Denominators

Categories

Stage 3 [N=56]

Title	Measurements
	OG00030.4

Stage 4 [N=82]

Title	Measurements
	OG00030.5

Stage 5 [N=580]

Secondary

Number of Participants With Hypercalcemia

Hypercalcemia was defined as having a serum calcium level greater than 11.2 mg/dL (2.79 mmol/L), in one measurement. Serum calcium was measured at every study visit.

The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.

Posted

Number

participants

Months 0, 3, 6, 9, and 12

ID	Title	Description
OG000	Paricalcitol Pre-dialysis Group	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
OG001	Paricalcitol Dialysis Group	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.

Units	Counts

Secondary

Number of Participants With Hyperphosphatemia

Hyperphosphatemia was defined as having a serum phosphate level greater than 6.5 mg/dL (2.10 mmol/L), in one measurement. Serum phosphate was measured at every study visit.

Posted

Number

participants

Months 0, 3, 6, 9, and 12

ID	Title	Description
OG000	Paricalcitol Pre-dialysis Group	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
OG001	Paricalcitol Dialysis Group	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.

Units	Counts

Secondary

Number of Participants With Elevated Calcium-Phosphorus Product

Elevated Calcium-Phosphorus Product was defined as having a calcium-phosphate product level greater than 65 mg^2/dL^2, in one measurement. Serum calcium-phosphorus product was measured at every study visit.

Posted

Number

participants

Months 0, 3, 6, 9, and 12

ID	Title	Description
OG000	Paricalcitol Pre-dialysis Group	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
OG001	Paricalcitol Dialysis Group	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.

Units	Counts

Secondary

Mean Duration of Hospitalization by Visit

Posted

Mean

Standard Deviation

days

Months 0, 3, 6, 9, and 11

ID	Title	Description
OG000	Paricalcitol Pre-dialysis Group	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
OG001	Paricalcitol Dialysis Group	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.

Units	Counts
Participants	OG000

Secondary

Mean Duration of Disability by Visit

Posted

Mean

Standard Deviation

days

Months 0, 3, 6, 9, and 11

ID	Title	Description
OG000	Paricalcitol Pre-dialysis Group	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
OG001	Paricalcitol Dialysis Group	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.

Units	Counts
Participants	OG000

Primary

Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months

Participants with a determined chronic kidney disease (CKD) stage

Posted

Mean

Standard Deviation

days

Up to 12 months

ID	Title	Description
OG000	Paricalcitol	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.

Units	Counts
Participants	OG000

Secondary

Mean Intact Parathormone (iPTH) Levels by Visit

Posted

Mean

Standard Deviation

pmol/L

Months 0, 3, 6, 9, and 12

ID	Title	Description
OG000	Paricalcitol Pre-dialysis Group	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
OG001	Paricalcitol Dialysis Group	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.

Units	Counts
Participants	OG000

Secondary

Mean Calcium-Phosphate Product Levels by Visit

Posted

Mean

Standard Deviation

mmol²/l²

Months 0, 3, 6, 9, and 12

ID	Title	Description
OG000	Paricalcitol Pre-dialysis Group	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
OG001	Paricalcitol Dialysis Group	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected96 at risk EG0010 affected637 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Angina pectoris	Cardiac disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Aortic valve disease mixed	Cardiac disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0012 affected637 at risk
Arrhythmia	Cardiac disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Cardiac arrest	Cardiac disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0013 affected637 at risk
Cardiac failure	Cardiac disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0015 affected637 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected637 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected637 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Coronary artery disease	Cardiac disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected96 at risk EG0013 affected637 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Left ventricular failure	Cardiac disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Myocardial infarction	Cardiac disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0014 affected637 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0011 affected637 at risk
Congenital cystic kidney disease	Congenital, familial and genetic disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Amaurosis	Eye disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Cataract	Eye disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Diverticular hernia	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Gastritis	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected637 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0003 affected96 at risk EG0012 affected637 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Ileus	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Mesenteric vein thrombosis	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Subileus	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Asthenia	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Cardiac death	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Chest pain	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Death	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG00113 affected637 at risk
Device dislocation	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0013 affected637 at risk
Device malfunction	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Device occlusion	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Fat necrosis	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
General physical health deterioration	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Hernia obstructive	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Hyperplasia	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Impaired healing	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Inflammation	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Local swelling	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Multi-organ failure	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Pain	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Sudden cardiac death	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0013 affected637 at risk
Sudden death	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Ulcer	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Liver transplant rejection	Immune system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Appendicitis	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0011 affected637 at risk
Catheter site infection	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Cellulitis	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Cerebral toxoplasmosis	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected637 at risk
Device related infection	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Device related sepsis	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Empyema	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Endocarditis	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Erysipelas	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Gangrene	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Gastroenteritis	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0011 affected637 at risk
Infection	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Intervertebral discitis	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Lyme disease	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Osteomyelitis	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Peritonitis	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0013 affected637 at risk
Pneumonia	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0014 affected637 at risk
Sepsis	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0018 affected637 at risk
Sinusitis	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Soft tissue infection	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Superinfection bacterial	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Arteriovenous fistula occlusion	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0014 affected637 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0013 affected637 at risk
Haemodialysis complication	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Post procedural stroke	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Shunt aneurysm	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Shunt malfunction	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Shunt occlusion	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG00112 affected637 at risk
Shunt stenosis	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Shunt thrombosis	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Skin injury	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Angiogram	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Arteriogram coronary	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Blood parathyroid hormone increased	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Catheterisation cardiac	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Colonoscopy	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
C-reactive protein increased	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Endoscopy	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Endoscopy upper gastrointestinal tract	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Investigation	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Weight decreased	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Calciphylaxis	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected637 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected637 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected637 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Adenoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected637 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Cerebral infarction	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Dementia	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Epilepsy	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
IIIrd nerve paresis	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Presyncope	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Syncope	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0013 affected637 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Restlessness	Psychiatric disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Haematuria	Renal and urinary disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Proteinuria	Renal and urinary disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected637 at risk
Renal failure	Renal and urinary disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected637 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected637 at risk
Renal impairment	Renal and urinary disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected637 at risk
Adenomyosis	Reproductive system and breast disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0013 affected637 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected637 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected637 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0011 affected637 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0015 affected637 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected637 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Abscess management	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Angioplasty	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Aortic valve replacement	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Arteriovenous fistula operation	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0018 affected637 at risk
Arteriovenous shunt operation	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0013 affected637 at risk
Cardiac pacemaker insertion	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0011 affected637 at risk
Cataract operation	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Catheter placement	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0011 affected637 at risk
Central venous catheterisation	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0013 affected637 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Dialysis	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected637 at risk
Foot amputation	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Hospitalisation	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0017 affected637 at risk
Inguinal hernia repair	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Leg amputation	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0013 affected637 at risk
Mitral valve repair	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Nephrectomy	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Parathyroid gland operation	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Parathyroidectomy	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Rehabilitation therapy	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Removal of ambulatory peritoneal catheter	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Renal transplant	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0013 affected637 at risk
Resection of rectum	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Stent placement	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Thyroidectomy	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0013 affected637 at risk
Toe amputation	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Transplant	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Umbilical hernia repair	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Urinary tract operation	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Venous operation	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Arteriosclerosis	Vascular disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Circulatory collapse	Vascular disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected637 at risk
Extremity necrosis	Vascular disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0013 affected637 at risk
Haemorrhage	Vascular disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Hypertensive crisis	Vascular disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0018 affected637 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0019 affected637 at risk
Poor peripheral circulation	Vascular disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Steal syndrome	Vascular disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Subclavian artery occlusion	Vascular disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk
Vasculitis	Vascular disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected637 at risk

ID	Term
D051437	Renal Insufficiency
D006962	Hyperparathyroidism, Secondary
D051436	Renal Insufficiency, Chronic
D009362	Neoplasm Metastasis

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D006961	Hyperparathyroidism
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009385	Neoplastic Processes
D009369	Neoplasms

ID	Title	Description
BG000	Paricalcitol Pre-dialysis Group	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
BG001	Paricalcitol Dialysis Group	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Paricalcitol Pre-dialysis Group	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.			16	96	0	96
EG001	Paricalcitol Dialysis Group	Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.			186	637	0	637