E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochlori... | NCT00345839

E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochlori... | NCT00345839 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Cinacalcet	Experimental		Drug: Cinacalcet
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cinacalcet	Drug	Possible doses: 30, 60, 90, 120, and 180 mg using tablet strengths of 30, 60, or 90 mg. Sequential titration starting at 30 mg daily (QD), once every 4 weeks for the first 20 weeks and once every 8 weeks after Week 20. Titration increases or decreases based on PTH values, serum calcium, and safety. Daily dosing unless temporary hold criteria or withdrawal criteria is met, or until study completion; estimated 2.5 to 4 years of intervention.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event)	Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event). Stratified by history of diabetes and country.	From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years

Secondary Outcomes

Measure	Description	Time Frame
Time to All-cause Mortality	Time to All-cause Mortality. Stratified by history of diabetes and country.	From date of randomization until date of confirmed all-cause mortality endpoint event, assessed up to 5.4 years
Time to Myocardial Infarction

Name	Affiliation	Role
MD	Amgen	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22529163	Background	Chertow GM, Correa-Rotter R, Block GA, Drueke TB, Floege J, Goodman WG, Herzog CA, Kubo Y, London GM, Mahaffey KW, Mix TC, Moe SM, Wheeler DC, Parfrey PS. Baseline characteristics of subjects enrolled in the Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) trial. Nephrol Dial Transplant. 2012 Jul;27(7):2872-9. doi: 10.1093/ndt/gfr777. Epub 2012 Apr 23.
17702710

Label	URL
AmgenTrials clinical trials website	View source

Arm/Group Information

ID	Title	Description
FG000	Cinacalcet	Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
FG001	Placebo	Participants were given matching placebo tablets compared to the cinacalcet group.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0001948 subjectsRandomized to cinacalcet FG0011935 subjectsRandomized to placebo
COMPLETED		FG0001799 subjectsParticipants who completed study includes those with ended study due to death. FG0011776 subjectsParticipants who completed study includes those with ended study due to death.
NOT COMPLETED		FG000149 subjects FG001159 subjects

Type	Comment	Reasons
Withdrawal by Subject		FG00091 subjects FG00198 subjects
Lost to Follow-up		FG00058 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Cinacalcet	Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
BG001	Placebo

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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

Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event)

Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event). Stratified by history of diabetes and country.

Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Posted

Median

Inter-Quartile Range

Months

From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years

ID	Title	Description
OG000	Cinacalcet	Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.

Adverse Events Module

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Study Director	Amgen Inc.	866-572-6436

Condition Browse Module

ID	Term
D006962	Hyperparathyroidism, Secondary
D051436	Renal Insufficiency, Chronic

ID	Term
D006961	Hyperparathyroidism
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases
D051437	Renal Insufficiency

Intervention Browse Module

ID	Term
D000069449	Cinacalcet

ID	Term
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

White or Caucasian

Title	Measurements
	BG0001124 BG0011116 BG0022240

Black or African American

Title	Measurements
	BG000409 BG001428 BG002837

Hispanic or Latino

Title	Measurements
	BG000317 BG001310 BG002627

Asian

Title	Measurements
	BG00047 BG00138 BG00285

Japanese

Title	Measurements
	BG0004 BG0011 BG0025

American Indian or Alaska Native

Title	Measurements
	BG0005 BG0017 BG00212

Native Hawaiian or Other Pacific Islander

Title	Measurements
	BG00012 BG0019 BG00221

Aborigine

Title	Measurements
	BG0001 BG0014 BG0025

Other

Title	Measurements
	BG00029 BG00122 BG00251

History of Diabetes Stratification Factor

History of diabetes stratification factor from the interactive voice response system.

Number

Participants

Title

Denominators

Categories

Diabetes

Title	Measurements
	BG000619 BG001614 BG0021233

No Diabetes

Title	Measurements
	BG0001329 BG0011321 BG0022650

Country stratification factor

Country stratification factor from the interactive voice response system. Denmark and Sweden were combined to create Nordic stratum.

Number

Participants

Title

Denominators

Categories

Argentina

Title	Measurements
	BG000171 BG001170 BG002341

Australia

Title	Measurements
	BG00074 BG00175 BG002149

Austria

Title	Measurements
	BG00031 BG00129 BG00260

Belgium

Title	Measurements
	BG00050 BG00150 BG002100

Brazil

Title	Measurements
	BG000151 BG001150 BG002301

Canada

Title	Measurements
	BG00073 BG00173 BG002146

Denmark

Title	Measurements
	BG0008 BG00111 BG00219

France

Title	Measurements
	BG00040 BG00140 BG00280

Germany

Title	Measurements
	BG00081 BG00181 BG002162

Hungary

Title	Measurements
	BG00066 BG00167 BG002133

Ireland

Title	Measurements
	BG0005 BG0016 BG00211

Italy

Title	Measurements
	BG00069 BG00168 BG002137

Mexico

Title	Measurements
	BG00023 BG00122 BG00245

Netherlands

Title	Measurements
	BG00015 BG00114 BG00229

Poland

Title	Measurements
	BG00059 BG00157 BG002116

Portugal

Title	Measurements
	BG00022 BG00121 BG00243

Russia

Title	Measurements
	BG000143 BG001140 BG002283

Spain

Title	Measurements
	BG00040 BG00138 BG00278

Sweden

Title	Measurements
	BG00013 BG00110 BG00223

Switzerland

Title	Measurements
	BG00018 BG00119 BG00237

United Kingdom

Title	Measurements
	BG00081 BG00179 BG002160

United States

Title	Measurements
	BG000715 BG001715 BG0021430

Title

Denominators

Categories

Title	Measurements
	OG00055.0(22.6 to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events. OG00153.0(19.1 to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	Stratified by history of diabetes and country. 2-sided test.	0.112	p-value<0.044 considered significant													Superiority or Other (legacy)
OG000 OG001		Regression, Cox	Stratified by history of diabetes and country.			Hazard Ratio (HR)	0.93			2-Sided	95	0.85	1.02			HR is cinacalcet vs placebo.		Superiority or Other (legacy)

Secondary

Time to All-cause Mortality

Time to All-cause Mortality. Stratified by history of diabetes and country.

Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Posted

Median

Inter-Quartile Range

Months

From date of randomization until date of confirmed all-cause mortality endpoint event, assessed up to 5.4 years

ID	Title	Description
OG000	Cinacalcet	Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
OG001	Placebo	Participants were given matching placebo tablets compared to the cinacalcet group.

Units	Counts
Participants	OG0001948 OG0011935

Title

Denominators

Categories

Title	Measurements
	OG000NA(37.9 to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events. OG001NA(31.6 to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	Stratified by history of diabetes and country. 2-sided test.	0.249	No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.													Superiority or Other (legacy)

Secondary

Time to Myocardial Infarction

Time to Myocardial Infarction. Stratified by history of diabetes and country.

Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Posted

Median

Inter-Quartile Range

Months

From date of randomization until date of first confirmed myocardial infarction endpoint event, assessed up to 5.4 years

ID	Title	Description
OG000	Cinacalcet	Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
OG001	Placebo	Participants were given matching placebo tablets compared to the cinacalcet group.

Units	Counts
Participants	OG0001948 OG0011935

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events. OG001NA(NA to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	Stratified by history of diabetes and country. 2-sided test.	0.800	No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.													Superiority or Other (legacy)

Secondary

Time to Hospitalization for Unstable Angina

Time to Hospitalization for Unstable Angina. Stratified by history of diabetes and country.

Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Posted

Median

Inter-Quartile Range

Months

From date of randomization until date of first confirmed hospitalization for unstable angina endpoint event, assessed up to 5.4 years

ID	Title	Description
OG000	Cinacalcet	Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
OG001	Placebo	Participants were given matching placebo tablets compared to the cinacalcet group.

Units	Counts
Participants	OG0001948 OG0011935

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events. OG001NA(NA to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	Stratified by history of diabetes and country. 2-sided test.	0.283	No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.													Superiority or Other (legacy)

Secondary

Time to Heart Failure

Time to Heart Failure. Stratified by history of diabetes and country.

Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Posted

Median

Inter-Quartile Range

Months

From date of randomization until date of first confirmed heart failure endpoint event, assessed up to 5.4 years

ID	Title	Description
OG000	Cinacalcet	Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
OG001	Placebo	Participants were given matching placebo tablets compared to the cinacalcet group.

Units	Counts
Participants	OG0001948 OG0011935

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events. OG001NA(NA to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	Stratified by history of diabetes and country. 2-sided test.	0.034	No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.													Superiority or Other (legacy)

Secondary

Time to Peripheral Vascular Event

Time to Peripheral Vascular Event. Stratified by history of diabetes and country.

Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Posted

Median

Inter-Quartile Range

Months

From date of randomization until date of first confirmed peripheral vascular endpoint event, assessed up to 5.4 years

ID	Title	Description
OG000	Cinacalcet	Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
OG001	Placebo	Participants were given matching placebo tablets compared to the cinacalcet group.

Units	Counts
Participants	OG0001948 OG0011935

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events. OG001NA(NA to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	Stratified by history of diabetes and country. 2-sided test.	0.190	No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.													Superiority or Other (legacy)

Secondary

Time to Cardiovascular Mortality

Time to Cardiovascular Mortality. Stratified by history of diabetes and country.

Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Posted

Median

Inter-Quartile Range

Months

From date of randomization until date of first confirmed cardiovascular mortality endpoint event, assessed up to 5.4 years

ID	Title	Description
OG000	Cinacalcet	Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
OG001	Placebo	Participants were given matching placebo tablets compared to the cinacalcet group.

Units	Counts
Participants	OG0001948 OG0011935

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events. OG001NA(NA to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	Stratified by history of diabetes and country. 2-sided test.	0.277	No adjustments for multiple comparisons were made for this endpoint.													Superiority or Other (legacy)
OG000 OG001		Regression, Cox

Secondary

Time to Stroke

Time to Stroke. Stratified by history of diabetes and country.

Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Posted

Median

Inter-Quartile Range

Months

From date of randomization until date of first confirmed stroke endpoint event, assessed up to 5.4 years

ID	Title	Description
OG000	Cinacalcet	Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
OG001	Placebo	Participants were given matching placebo tablets compared to the cinacalcet group.

Units	Counts
Participants	OG0001948 OG0011935

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events. OG001NA(NA to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	Stratified by history of diabetes and country. 2-sided test.	0.607	No adjustments for multiple comparisons were made for this endpoint.													Superiority or Other (legacy)
OG000 OG001		Regression, Cox

Secondary

Time to Bone Fracture

Time to Bone Fracture. Stratified by history of diabetes and country.

Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Posted

Median

Inter-Quartile Range

Months

From date of randomization until date of first confirmed bone fracture endpoint event, assessed up to 5.4 years

ID	Title	Description
OG000	Cinacalcet	Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
OG001	Placebo	Participants were given matching placebo tablets compared to the cinacalcet group.

Units	Counts
Participants	OG0001948 OG0011935

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events. OG001NA(NA to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	Stratified by history of diabetes and country. 2-sided test.	0.218	No adjustments for multiple comparisons were made for this endpoint.													Superiority or Other (legacy)
OG000 OG001		Regression, Cox

Secondary

Time to Parathyroidectomy

Time to Parathyroidectomy. Stratified by history of diabetes and country.

Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.

Posted

Median

Inter-Quartile Range

Months

From date of randomization until date of first confirmed parathyroidectomy endpoint event, assessed up to 5.4 years

ID	Title	Description
OG000	Cinacalcet	Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
OG001	Placebo	Participants were given matching placebo tablets compared to the cinacalcet group.

Units	Counts
Participants	OG0001948 OG0011935

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events. OG001NA(NA to NA)NA (Not Applicable) indicates that the parameter is not estimable due to insufficient number of subjects with events.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	Stratified by history of diabetes and country. 2-sided test.	<0.001	No adjustments for multiple comparisons were made for this endpoint.													Superiority or Other (legacy)
OG000 OG001		Regression, Cox