Trial Outcomes & Findings for Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet (NCT NCT01896232)

NCT ID: NCT01896232

Last Updated: 2019-07-18

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

683 participants

Primary outcome timeframe

Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).

Results posted on

2019-07-18

Participant Flow

This study was conducted at 164 centers in Austria, Belgium, Canada, the Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, New Zealand, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Turkey, and the United States. Participants were enrolled from 13 August 2013 to 16 May 2014.

Eligible participants were stratified by screening serum parathyroid hormone (PTH) level (\< 900 or ≥ 900 pg/mL) and region (North America or non-North America) and were randomized 1:1 to receive etelcalcetide intravenously (IV) plus oral placebo or oral cinacalcet plus placebo IV.

Participant milestones

Participant milestones
Measure	Cinacalcet Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.	Etelcalcetide Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Overall Study STARTED	343	340
Overall Study Received Treatment	341	338
Overall Study COMPLETED	294	287
Overall Study NOT COMPLETED	49	53

Reasons for withdrawal

Reasons for withdrawal
Measure	Cinacalcet Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.	Etelcalcetide Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Overall Study Death	6	10
Overall Study Withdrawal by Subject	32	31
Overall Study Sponsor Decision	2	0
Overall Study Lost to Follow-up	9	12

Baseline Characteristics

Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cinacalcet n=343 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.	Etelcalcetide n=340 Participants Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.	Total n=683 Participants Total of all reporting groups
Age, Continuous	55.3 years STANDARD_DEVIATION 14.4 • n=93 Participants	54.0 years STANDARD_DEVIATION 13.8 • n=4 Participants	54.7 years STANDARD_DEVIATION 14.1 • n=27 Participants
Age, Customized < 65 years	243 participants n=93 Participants	262 participants n=4 Participants	505 participants n=27 Participants
Age, Customized ≥ 65 years	100 participants n=93 Participants	78 participants n=4 Participants	178 participants n=27 Participants
Sex: Female, Male Female	151 Participants n=93 Participants	148 Participants n=4 Participants	299 Participants n=27 Participants
Sex: Female, Male Male	192 Participants n=93 Participants	192 Participants n=4 Participants	384 Participants n=27 Participants
Race Asian	7 participants n=93 Participants	9 participants n=4 Participants	16 participants n=27 Participants
Race Black	52 participants n=93 Participants	54 participants n=4 Participants	106 participants n=27 Participants
Race Native Hawaiian or Other Pacific Islander	3 participants n=93 Participants	6 participants n=4 Participants	9 participants n=27 Participants
Race White	277 participants n=93 Participants	261 participants n=4 Participants	538 participants n=27 Participants
Race Other	4 participants n=93 Participants	10 participants n=4 Participants	14 participants n=27 Participants
Ethnicity Hispanic/Latino	41 participants n=93 Participants	38 participants n=4 Participants	79 participants n=27 Participants
Ethnicity Not Hispanic/Latino	302 participants n=93 Participants	302 participants n=4 Participants	604 participants n=27 Participants
Stratification Factor: Screening Serum Parathyroid Hormone (PTH) < 900 pg/mL	171 participants n=93 Participants	169 participants n=4 Participants	340 participants n=27 Participants
Stratification Factor: Screening Serum Parathyroid Hormone (PTH) ≥ 900 pg/mL	172 participants n=93 Participants	171 participants n=4 Participants	343 participants n=27 Participants
Stratification Factor: Region North America	105 participants n=93 Participants	103 participants n=4 Participants	208 participants n=27 Participants
Stratification Factor: Region Non-North America	238 participants n=93 Participants	237 participants n=4 Participants	475 participants n=27 Participants
Parathyroid Hormone	1138.71 pg/mL STANDARD_DEVIATION 706.77 • n=93 Participants	1092.12 pg/mL STANDARD_DEVIATION 622.81 • n=4 Participants	1115.52 pg/mL STANDARD_DEVIATION 666.22 • n=27 Participants
Corrected Calcium	9.58 mg/dL STANDARD_DEVIATION 0.67 • n=93 Participants	9.67 mg/dL STANDARD_DEVIATION 0.71 • n=4 Participants	9.62 mg/dL STANDARD_DEVIATION 0.69 • n=27 Participants
Phosphorus	5.82 mg/dL STANDARD_DEVIATION 1.58 • n=93 Participants	5.81 mg/dL STANDARD_DEVIATION 1.69 • n=4 Participants	5.81 mg/dL STANDARD_DEVIATION 1.63 • n=27 Participants
Corrected Calcium Phosphorus Product (cCa x P)	55.65 mg²/dL² STANDARD_DEVIATION 15.37 • n=93 Participants	56.36 mg²/dL² STANDARD_DEVIATION 17.15 • n=4 Participants	56.00 mg²/dL² STANDARD_DEVIATION 16.27 • n=27 Participants

PRIMARY outcome

Timeframe: Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).

Population: Full analysis set participants with PTH data during the EAP

Outcome measures

Outcome measures
Measure	Cinacalcet n=310 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.	Etelcalcetide n=298 Participants Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Percentage of Participants With > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis	63.9 percentage of participants	77.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline and the efficacy assessment phase (Weeks 20 to 27, inclusive).

Population: Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP (ie, non-responder imputation).

Outcome measures

Outcome measures
Measure	Cinacalcet n=343 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.	Etelcalcetide n=340 Participants Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase	40.2 percentage of participants	52.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline and the efficacy assessment phase (Week 20 to Week 27)

Population: Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP (ie, non-responder imputation).

Outcome measures

Outcome measures
Measure	Cinacalcet n=343 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.	Etelcalcetide n=340 Participants Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase	57.7 percentage of participants	68.2 percentage of participants

SECONDARY outcome

Timeframe: First 8 weeks

Population: Full analysis set with available data. For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.

Participants completed the Nausea/Vomiting Symptom Assessment (NVSA) questionnaire daily. This questionnaire asked participants to indicate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined) and if they had vomited in the past 24 hours. A day of vomiting or nausea was defined as those where the severity of nausea score was \> 0 or where the episodes of vomiting score was \> 0.

Outcome measures

Outcome measures
Measure	Cinacalcet n=324 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.	Etelcalcetide n=331 Participants Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks	0.3 days of vomiting or nausea per week Standard Error 0.03	0.4 days of vomiting or nausea per week Standard Error 0.04

SECONDARY outcome

Timeframe: Baseline and the efficacy assessment phase (weeks 20 - 27)

Population: Full analysis set with available data.

Outcome measures

Outcome measures
Measure	Cinacalcet n=310 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.	Etelcalcetide n=298 Participants Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase	-6.28 percent change Standard Error 0.44	-9.83 percent change Standard Error 0.49

SECONDARY outcome

Timeframe: Efficacy assessment phase (weeks 20 - 27)

Population: Full analysis set; participants with no phosphorus assessments during the EAP were considered non-responders.

Outcome measures

Outcome measures
Measure	Cinacalcet n=343 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.	Etelcalcetide n=340 Participants Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase	29.2 percentage of participants	32.1 percentage of participants

SECONDARY outcome

Timeframe: First 8 weeks

Population: Full analysis set with available data

Severity of nausea was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asked participants to rate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined). For each participant, the mean severity of nausea was calculated by averaging all available daily severities (including zeroes) reported in the first 8 weeks.

Outcome measures

Outcome measures
Measure	Cinacalcet n=339 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.	Etelcalcetide n=339 Participants Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Mean Severity of Nausea in the First 8 Weeks	0.48 units on a scale Standard Error 0.06	0.45 units on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: First 8 weeks

The number of vomiting episodes was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asks participants on a daily basis how many times they vomited in the past 24 hours. The number of episodes in a week is the sum of all reported daily episodes in the week. For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.

Outcome measures

Outcome measures
Measure	Cinacalcet n=324 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.	Etelcalcetide n=331 Participants Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Mean Number of Episodes of Vomiting Per Week in the First 8 Weeks	0.1 vomiting episodes per week Standard Error 0.02	0.2 vomiting episodes per week Standard Error 0.02

Adverse Events

Cinacalcet

Serious events: 93 serious events

Other events: 259 other events

Deaths: 0 deaths

Etelcalcetide

Serious events: 85 serious events

Other events: 278 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Cinacalcet n=341 participants at risk Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.	Etelcalcetide n=338 participants at risk Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Blood and lymphatic system disorders Anaemia	3.2% 11/341 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.0% 17/338 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diarrhoea	10.0% 34/341 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.2% 21/338 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Nausea	22.6% 77/341 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	18.3% 62/338 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Vomiting	13.5% 46/341 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	13.0% 44/338 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood calcium decreased	59.5% 203/341 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	68.6% 232/338 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypocalcaemia	2.3% 8/341 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.0% 17/338 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Muscle spasms	5.9% 20/341 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.5% 22/338 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Pain in extremity	3.8% 13/341 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.0% 17/338 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Headache	7.0% 24/341 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.2% 21/338 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertension	6.5% 22/341 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 20/338 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypotension	2.9% 10/341 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.2% 21/338 • From Day 1 until 30 days after the last dose; the treatment period was 26 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

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