Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice

• Sponsor: Amgen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01652690
• Collaborator: One Amgen Center Drive (Other), THOUSAND OAKS (Other), CA (Other), 91320-1799 (Other), USA (Other)
• Enrollment: 600
• Locations: 29
• Actual Duration (Months): 34.6
• Patients Per Site: 20.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The objective of this prospective, observational study in Czech Republic and Slovakia is to describe per country the characteristics of women treated with denosumab in routine clinical practice and the clinical management of these patients during the first 2 years of treatment. In addition, the study aims to collect safety data in the real-life clinical practice settings on adverse drug reactions (ADRs) and serious ADRs.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis, Postmenopausal	Biological: Denosumab

Study Design

• Study Type: Observational
• Actual Enrollment: 600 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Observational Study to Describe Characteristics and Management of Patients With Postmenopausal Osteoporosis Treated With Prolia® in Routine Clinical Practice
• Actual Study Start Date: Jun 26, 2012
• Actual Primary Completion Date: May 15, 2015
• Actual Study Completion Date: May 15, 2015

Arms and Interventions

Arm	Intervention/Treatment
Denosumab Patients with postmenopausal osteoporosis (PMO) who received at least 1 injection of denosumab 60 mg subcutaneously in the Czech Republic and Slovakia.	Biological: Denosumab; This is an non-interventional study, therefore denosumab is administered as part of routine care and not for purposes of the study.; Other Names: Prolia®

Outcome Measures

Primary Outcome Measures

1. Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office [24 months]

   Number of participants who received all injection(s), including baseline injection, from the initial prescribing site irrespective of total number of injections received on study.

2. Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection [Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)]

3. Number of Participants Receiving All Prescriptions and Injections of Denosumab [Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)]

   Number of participants receiving all prescriptions and injections of denosumab whether or not the injections are given at the initial prescribing physician's office.

4. Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care [24 months]

5. Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection [Baseline (day 1)]

   Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection.

6. Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection [Month 6]

   Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the first post-baseline injection.

7. Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection [Month 12]

   Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the second post-baseline injection.

8. Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection [Month 18]

   Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the third post-baseline injection.

9. Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection [Month 24]

   Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the fourth post-baseline injection.

10. Number of Denosumab Post-baseline Injections Received by Each Participant [24 months]

11. Number of Participants Having Radiologic Bone Assessments [Pre-baseline (before first denosumab injection) and during the study (post-baseline)]

    Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.

12. Number of Participants Having Osteoporosis Related Laboratory Examinations [Pre-baseline (before first denosumab injection) and post-baseline]

    Number of participants having osteoporosis related laboratory examinations pre-treatment with denosumab and during the study. Participants may not have been given denosumab injection when they attended each visit.

Secondary Outcome Measures

1. Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab [24 months]

   Adverse events (AEs) that were considered related to denosumab as evaluated by the investigator were classified as adverse drug reactions (ADRs).

2. Number of Participants With Serious ADRs to Denosumab [24 months]

   Serious adverse events that were considered related to denosumab were classified as serious adverse drug reactions (SADRs). A serious adverse event (SAE) is any AE that also: • is fatal • is life threatening (places the patient at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is an "other significant medical hazard" that does not meet any of the above criteria.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria

• Women with a clinical diagnosis of postmenopausal osteoporosis

• Decision has been made to treat with denosumab 60 mg once every 6 months

• Have received their first injection of denosumab within 8 weeks prior to enrolling in this study.

• Appropriate written informed consent has been obtained (as required per local country regulations)

Exclusion Criteria

• Participating in ongoing or have participated in previous denosumab clinical trials

• Participation in other clinical or device trials in the last 6 months

• Contra-indicated for treatment with Prolia® according to the approved applicable local product label.

• Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Brno		Czechia	602 00
2	Research Site	Brno		Czechia	638 00
3	Research Site	Ceske Budejovice		Czechia	370 01
4	Research Site	Havlickuv Brod		Czechia	580 22
5	Research Site	Karlovy Vary		Czechia	367 17
6	Research Site	Kutna Hora		Czechia	284 01
7	Research Site	Ostrava-Trebovice		Czechia	722 00
8	Research Site	Ostrava		Czechia	702 00
9	Research Site	Plzen		Czechia	323 00
10	Research Site	Praha 11		Czechia	148 00
11	Research Site	Praha 2		Czechia	128 50
12	Research Site	Praha 4 - Nusle		Czechia	140 00
13	Research Site	Trutnov		Czechia	541 21
14	Research Site	Vsetin		Czechia	755 01
15	Research Site	Zlin		Czechia	760 01
16	Osteocentrum Zlin	Zlin		Czechia
17	Research Site	Banska Bystrica		Slovakia	974 01
18	Research Site	Bratislava		Slovakia	826 06
19	Research Site	Bratislava		Slovakia	833 05
20	Research Site	Humenne		Slovakia	066 01
21	Research Site	Kosice-Saca		Slovakia	040 15
22	Research Site	Kosice		Slovakia	040 01
23	Research Site	Lubochna		Slovakia	034 91
24	Research Site	Lucenec		Slovakia	984 01
25	Research Site	Martin		Slovakia	036 01
26	Research Site	Nitra		Slovakia	949 01
27	Research Site	Presov		Slovakia	080 01
28	Research Site	Trnava		Slovakia	917 75
29	Research Site	Zilina		Slovakia	010 01

Sponsors and Collaborators

• Amgen
• One Amgen Center Drive
• THOUSAND OAKS
• CA
• 91320-1799
• USA

Investigators

• Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• AmgenTrials clinical trials website

Publications

• Růžičková O, Killinger Z, Kasalický P, Hamilton L, Tyl R, Tomková S, Kalouche-Khalil L. Real-world Management of Women with Postmenopausal Osteoporosis Treated with Denosumab: A Prospective Observational Study in the Czech Republic and Slovakia. Adv Ther. 2018 Oct;35(10):1713-1728. doi: 10.1007/s12325-018-0779-9. Epub 2018 Sep 6.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT01652690
• Other Study ID Numbers: 20110132
• First Posted: Jul 30, 2012
• Last Update Posted: Mar 6, 2019
• Last Verified: Mar 1, 2019

• Additional relevant MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Denosumab

Study Results

Participant Flow

Recruitment Details	The study was conducted at various study centers in the Czech Republic and Slovakia. The recruitment period was from 26 June 2012 to 15 May 2013.

Arm/Group Title	Czech Republic	Slovakia
Arm/Group Description	Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Period Title: Overall Study
STARTED	300	300
COMPLETED	265	279
NOT COMPLETED	35	21

Baseline Characteristics

Arm/Group Title	Czech Republic	Slovakia	Total
Arm/Group Description	Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Total of all reporting groups
Overall Participants	300	300	600
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.0 (8.7)	64.3 (8.6)	66.7 (9.0)
Sex: Female, Male (Count of Participants)
Female	300 100%	300 100%	600 100%
Male	0 0%	0 0%	0 0%
Age at Menopause (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.3 (5.6)	48.3 (5.2)	48.3 (5.4)
Time Since Postmenopausal Osteoarthritis Diagnosis (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	5.3 (5.2)	3.0 (4.1)	4.1 (4.8)

Outcome Measures

1. Primary Outcome

Title	Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office
Description	Number of participants who received all injection(s), including baseline injection, from the initial prescribing site irrespective of total number of injections received on study.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Full analysis set (all enrolled patients who provided informed consent and received at least one injection)

Arm/Group Title	Czech Republic	Slovakia
Arm/Group Description	Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Measure Participants	300	300
Number [participants]	295 98.3%	296 98.7%

2. Primary Outcome

Title	Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection
Time Frame	Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)

Outcome Measure Data

Analysis Population Description

Full analysis set; n = the number of participants who received the corresponding injection

Arm/Group Title	Czech Republic	Slovakia
Arm/Group Description	Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Measure Participants	300	300
Baseline injection (n = 300, 300)	300 100%	298 99.3%
First post-baseline injection (n = 283, 293)	282 94%	291 97%
Second post-baseline injection (n = 276, 283)	275 91.7%	282 94%
Third post-baseline injection (n = 262, 276)	260 86.7%	274 91.3%
Fourth post-baseline injection (n = 246, 243)	245 81.7%	240 80%

3. Primary Outcome

Title	Number of Participants Receiving All Prescriptions and Injections of Denosumab
Description	Number of participants receiving all prescriptions and injections of denosumab whether or not the injections are given at the initial prescribing physician's office.
Time Frame	Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Czech Republic	Slovakia
Arm/Group Description	Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Measure Participants	300	300
First post-baseline injection	283 94.3%	293 97.7%
Second post-baseline injection	276 92%	283 94.3%
Third post-baseline injection	262 87.3%	276 92%
Fourth post-baseline injection	246 82%	243 81%

4. Primary Outcome

Title	Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Full analysis set participants who discontinued the study prematurely

Arm/Group Title	Czech Republic	Slovakia
Arm/Group Description	Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Measure Participants	35	21
Referred to other health care providers (total)	0 0%	2 0.7%
Referred to rheumatologist	0 0%	2 0.7%

5. Primary Outcome

Title	Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection
Description	Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection.
Time Frame	Baseline (day 1)

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Czech Republic	Slovakia
Arm/Group Description	Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Measure Participants	300	300
Prescribing Physician	54 18%	84 28%
Other Physician	19 6.3%	21 7%
Nurse	227 75.7%	195 65%

6. Primary Outcome

Title	Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection
Description	Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the first post-baseline injection.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

Full analysis set participants who received a first post-baseline injection (i.e. at month 6)

Arm/Group Title	Czech Republic	Slovakia
Arm/Group Description	Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Measure Participants	283	293
Prescribing Physician	70 23.3%	109 36.3%
Other Physician	8 2.7%	0 0%
Nurse	205 68.3%	184 61.3%

7. Primary Outcome

Title	Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection
Description	Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the second post-baseline injection.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

Full analysis set participants who received a second post-baseline injection (i.e. at month 12)

Arm/Group Title	Czech Republic	Slovakia
Arm/Group Description	Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Measure Participants	276	283
Prescribing Physician	75 25%	104 34.7%
Other Physician	0 0%	0 0%
Nurse	201 67%	179 59.7%

8. Primary Outcome

Title	Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection
Description	Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the third post-baseline injection.
Time Frame	Month 18

Outcome Measure Data

Analysis Population Description

Full analysis set participants who received a third post-baseline injection (i.e. at month 18)

Arm/Group Title	Czech Republic	Slovakia
Arm/Group Description	Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Measure Participants	262	276
Prescribing Physician	69 23%	113 37.7%
Other Physician	4 1.3%	1 0.3%
Nurse	189 63%	162 54%

9. Primary Outcome

Title	Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection
Description	Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the fourth post-baseline injection.
Time Frame	Month 24

Outcome Measure Data

Analysis Population Description

Full analysis set participants who received a fourth post-baseline injection (i.e. at month 24)

Arm/Group Title	Czech Republic	Slovakia
Arm/Group Description	Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Measure Participants	246	243
Prescribing Physician	76 25.3%	93 31%
Other Physician	0 0%	6 2%
Nurse	170 56.7%	144 48%

10. Primary Outcome

Title	Number of Denosumab Post-baseline Injections Received by Each Participant
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Czech Republic	Slovakia
Arm/Group Description	Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Measure Participants	300	300
No post-baseline injections	17 5.7%	7 2.3%
One post-baseline injection	7 2.3%	10 3.3%
Two post-baseline injections	14 4.7%	7 2.3%
Three post-baseline injections	16 5.3%	33 11%
Four post-baseline injections	246 82%	243 81%

11. Primary Outcome

Title	Number of Participants Having Radiologic Bone Assessments
Description	Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.
Time Frame	Pre-baseline (before first denosumab injection) and during the study (post-baseline)

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Czech Republic	Slovakia
Arm/Group Description	Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Measure Participants	300	300
Pre-baseline	297 99%	299 99.7%
Post-baseline	253 84.3%	216 72%

12. Primary Outcome

Title	Number of Participants Having Osteoporosis Related Laboratory Examinations
Description	Number of participants having osteoporosis related laboratory examinations pre-treatment with denosumab and during the study. Participants may not have been given denosumab injection when they attended each visit.
Time Frame	Pre-baseline (before first denosumab injection) and post-baseline

Outcome Measure Data

Analysis Population Description

Full analysis set; n = participants with visits at each time point.

Arm/Group Title	Czech Republic	Slovakia
Arm/Group Description	Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Measure Participants	300	300
Baseline injection (n = 300, 300)	230 76.7%	260 86.7%
First post-baseline injection (n = 285, 294)	148 49.3%	207 69%
Second post-baseline injection (n = 280, 286)	162 54%	224 74.7%
Third post-baseline injection (n = 270, 280)	163 54.3%	226 75.3%
Fourth post-baseline injection (n = 262, 263)	174 58%	223 74.3%

13. Secondary Outcome

Title	Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab
Description	Adverse events (AEs) that were considered related to denosumab as evaluated by the investigator were classified as adverse drug reactions (ADRs).
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Czech Republic	Slovakia
Arm/Group Description	Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Measure Participants	300	300
All adverse drug reactions	4 1.3%	12 4%
ADRs leading to discontinuation of denosumab	2 0.7%	5 1.7%
Fatal adverse drug reactions	0 0%	0 0%

14. Secondary Outcome

Title	Number of Participants With Serious ADRs to Denosumab
Description	Serious adverse events that were considered related to denosumab were classified as serious adverse drug reactions (SADRs). A serious adverse event (SAE) is any AE that also: • is fatal • is life threatening (places the patient at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is an "other significant medical hazard" that does not meet any of the above criteria.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Czech Republic	Slovakia
Arm/Group Description	Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.	Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
Measure Participants	300	300
All serious adverse drug reactions	0 0%	1 0.3%
SADRs leading to discontinuation of denosumab	0 0%	0 0%
Fatal serious ADRs	0 0%	0 0%

Adverse Events

Time Frame	24 months
Adverse Event Reporting Description	Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions that exceed the indicated frequency threshold. Serious Adverse Events summarizes serious adverse drug reactions which are defined as serious adverse events that are considered related to denosumab.
Arm/Group Title	Czech Republic		Slovakia
Arm/Group Description	Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.		Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
All Cause Mortality
	Czech Republic		Slovakia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Czech Republic		Slovakia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/300 (0%)		1/300 (0.3%)
Cardiac disorders
Myocardial infarction	0/300 (0%)		1/300 (0.3%)
Other (Not Including Serious) Adverse Events
	Czech Republic		Slovakia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/300 (0%)		0/300 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.