Trial Outcomes & Findings for A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis (NCT NCT03432533)
NCT ID: NCT03432533
Last Updated: 2020-11-23
Results Overview
Percent change from baseline in BMD at the lumbar spine as measured by dual-energy x-ray absorptiometry (DXA).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
283 participants
Primary outcome timeframe
Baseline, Month 6
Results posted on
2020-11-23
Participant Flow
Participants were enrolled at 36 centers in Poland, United Kingdom, and United States.
Participants were randomized in a 1:1 ratio.
Participant milestones
| Measure |
Romosozumab 210 mg QM: PFS
During the open-label treatment period, participants received 210 mg romosozumab subcutaneously (SC) once a month (QM) by health care provider (HCP) administration with pre-filled syringe (PFS).
|
Romosozumab 210 mg QM: AI/Pen
During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with autoinjector (AI)/pen.
|
|---|---|---|
|
Overall Study
STARTED
|
141
|
142
|
|
Overall Study
Completed 6-Month Treatment Period
|
136
|
137
|
|
Overall Study
COMPLETED
|
126
|
131
|
|
Overall Study
NOT COMPLETED
|
15
|
11
|
Reasons for withdrawal
| Measure |
Romosozumab 210 mg QM: PFS
During the open-label treatment period, participants received 210 mg romosozumab subcutaneously (SC) once a month (QM) by health care provider (HCP) administration with pre-filled syringe (PFS).
|
Romosozumab 210 mg QM: AI/Pen
During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with autoinjector (AI)/pen.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
14
|
9
|
Baseline Characteristics
Participants with an assessment at baseline.
Baseline characteristics by cohort
| Measure |
Romosozumab 210 mg QM: PFS
n=141 Participants
During the open-label treatment period, participants received 210 mg romosozumab SC QM by HCP administration with PFS.
|
Romosozumab 210 mg QM: AI/Pen
n=142 Participants
During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with AI/pen.
|
Total
n=283 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.3 years
STANDARD_DEVIATION 7.1 • n=141 Participants
|
69.5 years
STANDARD_DEVIATION 8.4 • n=142 Participants
|
69.9 years
STANDARD_DEVIATION 7.8 • n=283 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=141 Participants
|
142 Participants
n=142 Participants
|
283 Participants
n=283 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=141 Participants
|
0 Participants
n=142 Participants
|
0 Participants
n=283 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=141 Participants
|
1 Participants
n=142 Participants
|
4 Participants
n=283 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
138 Participants
n=141 Participants
|
141 Participants
n=142 Participants
|
279 Participants
n=283 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=141 Participants
|
0 Participants
n=142 Participants
|
0 Participants
n=283 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=141 Participants
|
0 Participants
n=142 Participants
|
0 Participants
n=283 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=141 Participants
|
1 Participants
n=142 Participants
|
2 Participants
n=283 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=141 Participants
|
0 Participants
n=142 Participants
|
0 Participants
n=283 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=141 Participants
|
1 Participants
n=142 Participants
|
2 Participants
n=283 Participants
|
|
Race (NIH/OMB)
White
|
139 Participants
n=141 Participants
|
140 Participants
n=142 Participants
|
279 Participants
n=283 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=141 Participants
|
0 Participants
n=142 Participants
|
0 Participants
n=283 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=141 Participants
|
0 Participants
n=142 Participants
|
0 Participants
n=283 Participants
|
|
Lumbar Spine Bone Mineral Density (BMD) T-Score
|
-2.69 T-score
STANDARD_DEVIATION 1.03 • n=141 Participants
|
-2.85 T-score
STANDARD_DEVIATION 1.00 • n=142 Participants
|
-2.77 T-score
STANDARD_DEVIATION 1.02 • n=283 Participants
|
|
Total Hip BMD T-Score
|
-2.29 T-score
STANDARD_DEVIATION 0.73 • n=141 Participants
|
-2.30 T-score
STANDARD_DEVIATION 0.77 • n=142 Participants
|
-2.29 T-score
STANDARD_DEVIATION 0.75 • n=283 Participants
|
|
Femoral Neck BMD T-Score
|
-2.54 T-score
STANDARD_DEVIATION 0.63 • n=141 Participants
|
-2.49 T-score
STANDARD_DEVIATION 0.65 • n=142 Participants
|
-2.52 T-score
STANDARD_DEVIATION 0.64 • n=283 Participants
|
|
Participants With Pre-Existing Anti-Romosozumab Antibodies
Binding Antibody Positive at or Before BL
|
3 Participants
n=139 Participants • Participants with an assessment at baseline.
|
0 Participants
n=141 Participants • Participants with an assessment at baseline.
|
3 Participants
n=280 Participants • Participants with an assessment at baseline.
|
|
Participants With Pre-Existing Anti-Romosozumab Antibodies
Neutralizing Antibody Positive at or Before BL
|
0 Participants
n=139 Participants • Participants with an assessment at baseline.
|
0 Participants
n=141 Participants • Participants with an assessment at baseline.
|
0 Participants
n=280 Participants • Participants with an assessment at baseline.
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: Primary Analysis Population: participants with lumbar spine BMD values at baseline and \>=1 postbaseline visit at Month 6.
Percent change from baseline in BMD at the lumbar spine as measured by dual-energy x-ray absorptiometry (DXA).
Outcome measures
| Measure |
Romosozumab 210 mg QM: PFS
n=135 Participants
During the open-label treatment period, participants received 210 mg romosozumab SC QM by HCP administration with PFS.
|
Romosozumab 210 mg QM: AI/Pen
n=134 Participants
During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with AI/pen.
|
|---|---|---|
|
Percent Change From Baseline in Lumbar Spine BMD at Month 6
|
9.2 percent change
Standard Error 0.4
|
9.0 percent change
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Primary Analysis Population: participants with lumbar spine BMD values at baseline and \>=1 postbaseline visit at Month 6.
Percent change from baseline in BMD for total hip as measured by DXA.
Outcome measures
| Measure |
Romosozumab 210 mg QM: PFS
n=135 Participants
During the open-label treatment period, participants received 210 mg romosozumab SC QM by HCP administration with PFS.
|
Romosozumab 210 mg QM: AI/Pen
n=134 Participants
During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with AI/pen.
|
|---|---|---|
|
Percent Change From Baseline in Total Hip BMD at Month 6
|
3.7 percent change
Standard Error 0.6
|
3.6 percent change
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Primary Analysis Population: participants with lumbar spine BMD values at baseline and \>=1 postbaseline visit at Month 6.
Percent change from baseline in BMD at femoral neck as measured by DXA.
Outcome measures
| Measure |
Romosozumab 210 mg QM: PFS
n=135 Participants
During the open-label treatment period, participants received 210 mg romosozumab SC QM by HCP administration with PFS.
|
Romosozumab 210 mg QM: AI/Pen
n=134 Participants
During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with AI/pen.
|
|---|---|---|
|
Percent Change From Baseline in Femoral Neck BMD at Month 6
|
3.4 percent change
Standard Error 0.7
|
3.6 percent change
Standard Error 0.5
|
SECONDARY outcome
Timeframe: up to Month 9 (-7/+3 days)Population: Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
AE: any untoward medical occurrence irrespective of a causal relationship with the study treatment. SAE: any untoward medical occurrence that meets at least 1 of the following criteria: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important serious event. Adverse device effect: any AE related to the use of a combination product or medical device. TEAEs are those AEs occurring after first dose of study drug.
Outcome measures
| Measure |
Romosozumab 210 mg QM: PFS
n=141 Participants
During the open-label treatment period, participants received 210 mg romosozumab SC QM by HCP administration with PFS.
|
Romosozumab 210 mg QM: AI/Pen
n=142 Participants
During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with AI/pen.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths
TEAEs: All
|
94 participants
|
96 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths
TEAEs: SAEs
|
7 participants
|
4 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths
TEAEs: Leading to Study Drug Discontinuation (DC)
|
7 participants
|
15 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths
TEAEs: Fatal
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths
Treatment-Related (TR) TEAEs: All
|
38 participants
|
59 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths
TR TEAEs: SAEs
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths
TR TEAEs: Leading to Study Drug DC
|
6 participants
|
10 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths
TR TEAEs: Fatal
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths
Device-Related (DR) TEAEs: All
|
18 participants
|
30 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths
DR TEAEs: SAEs
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths
DR TEAEs: Leading to Study Drug DC
|
0 participants
|
5 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths
DR TEAEs: Fatal
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: up to Month 9 (-7/+3 days)Population: Safety Analysis Set: all randomized participants who received at least 1 dose of study drug as well as baseline and postbaseline antibody results.
Participants with a negative or no result at baseline (BL) developing anti-romosozumab antibodies postbaseline, including those who were binding antibody-positive or neutralizing antibody-positive postbaseline. 'Transient' positive results are those with a negative result at the participant's last time point tested within the study period.
Outcome measures
| Measure |
Romosozumab 210 mg QM: PFS
n=139 Participants
During the open-label treatment period, participants received 210 mg romosozumab SC QM by HCP administration with PFS.
|
Romosozumab 210 mg QM: AI/Pen
n=142 Participants
During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with AI/pen.
|
|---|---|---|
|
Number of Participants Developing Anti-Romosozumab Antibodies
Transient Neutralizing Antibody Positive Post-BL
|
0 Participants
|
2 Participants
|
|
Number of Participants Developing Anti-Romosozumab Antibodies
Binding Antibody Positive Post-BL
|
21 Participants
|
22 Participants
|
|
Number of Participants Developing Anti-Romosozumab Antibodies
Transient Binding Antibody Positive Post-BL
|
6 Participants
|
3 Participants
|
|
Number of Participants Developing Anti-Romosozumab Antibodies
Neutralizing Antibody Positive Post-BL
|
5 Participants
|
4 Participants
|
Adverse Events
Romosozumab 210 mg SC QM by PFS
Serious events: 7 serious events
Other events: 48 other events
Deaths: 0 deaths
Romosozumab 210 mg SC QM by AI/Pen
Serious events: 4 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Romosozumab 210 mg SC QM by PFS
n=141 participants at risk
During the open-label treatment period, participants received 210 mg romosozumab SC, QM by HCP administration with PFS.
|
Romosozumab 210 mg SC QM by AI/Pen
n=142 participants at risk
During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with AI/pen.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.70%
1/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.71%
1/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.70%
1/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.71%
1/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
0.71%
1/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.71%
1/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.71%
1/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.71%
1/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.70%
1/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.71%
1/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.71%
1/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.71%
1/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.71%
1/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.70%
1/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Romosozumab 210 mg SC QM by PFS
n=141 participants at risk
During the open-label treatment period, participants received 210 mg romosozumab SC, QM by HCP administration with PFS.
|
Romosozumab 210 mg SC QM by AI/Pen
n=142 participants at risk
During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with AI/pen.
|
|---|---|---|
|
General disorders
Injection site erythema
|
17.7%
25/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
24.6%
35/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site pain
|
9.9%
14/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.8%
21/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site swelling
|
7.8%
11/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.2%
23/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
10.6%
15/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.0%
10/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
2/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
8/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
7/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
6.3%
9/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
2.1%
3/141 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
6.3%
9/142 • up to Month 9 (-7/+3 days)
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER