Trial Outcomes & Findings for Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism (NCT NCT01254565)
NCT ID: NCT01254565
Last Updated: 2017-04-13
Results Overview
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
Baseline and the efficacy assessment phase (EAP; defined as the period between 3 days before and 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
Results posted on
2017-04-13
Participant Flow
This study was conducted at 11 study centers in the United States from 17 February 2011 (first participant enrolled) to 24 August 2011 (last participant completed follow up). A total of 87 patients with secondary hyperparathyroidism (HPT) receiving hemodialysis were enrolled and randomized in the study.
This was a multiple-ascending dose study consisting of 3 cohorts: Cohort 1 participants were randomized in a 3:2 ratio to receive etelcalcetide or placebo for 2 weeks; Cohorts 2 and 3 were randomized in a 1:1 ratio to receive etelcalcetide or placebo for 4 weeks. Randomization was stratified by serum parathyroid hormone (\< 600 or ≥ 600 pg/mL).
Participant milestones
| Measure |
Cohort 1: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
|
Cohort 1: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
|
Cohort 2: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 2: Etelcalcetide 10 mg
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
21
|
21
|
16
|
17
|
|
Overall Study
Received Treatment
|
4
|
6
|
21
|
21
|
13
|
13
|
|
Overall Study
COMPLETED
|
4
|
6
|
21
|
20
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
1
|
4
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
|
Cohort 1: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
|
Cohort 2: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 2: Etelcalcetide 10 mg
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Non-compliance to Study Procedures
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Did not Receive Treatment
|
1
|
1
|
0
|
0
|
3
|
4
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Corrected calcium data were missing for 2 participants in Cohort 3.
Baseline characteristics by cohort
| Measure |
Cohort 1: Placebo
n=4 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
|
Cohort 1: Etelcalcetide 5 mg
n=6 Participants
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
|
Cohort 2: Placebo
n=21 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 2: Etelcalcetide 10 mg
n=21 Participants
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Placebo
n=13 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Etelcalcetide 5 mg
n=13 Participants
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 16.66 • n=4 Participants
|
54.0 years
STANDARD_DEVIATION 10.00 • n=6 Participants
|
52.4 years
STANDARD_DEVIATION 13.65 • n=21 Participants
|
50.7 years
STANDARD_DEVIATION 13.60 • n=21 Participants
|
56.7 years
STANDARD_DEVIATION 11.61 • n=13 Participants
|
59.6 years
STANDARD_DEVIATION 10.99 • n=13 Participants
|
53.7 years
STANDARD_DEVIATION 12.88 • n=78 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=4 Participants
|
4 Participants
n=6 Participants
|
8 Participants
n=21 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=13 Participants
|
5 Participants
n=13 Participants
|
30 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
13 Participants
n=21 Participants
|
15 Participants
n=21 Participants
|
8 Participants
n=13 Participants
|
8 Participants
n=13 Participants
|
48 Participants
n=78 Participants
|
|
Race
White
|
2 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=13 Participants
|
4 Participants
n=13 Participants
|
15 Participants
n=78 Participants
|
|
Race
Black or African American
|
2 Participants
n=4 Participants
|
5 Participants
n=6 Participants
|
20 Participants
n=21 Participants
|
18 Participants
n=21 Participants
|
9 Participants
n=13 Participants
|
9 Participants
n=13 Participants
|
63 Participants
n=78 Participants
|
|
Ethnicity
Hispanic or Latino
|
0 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=13 Participants
|
3 Participants
n=13 Participants
|
8 Participants
n=78 Participants
|
|
Ethnicity
Not Hispanic or Latino
|
4 Participants
n=4 Participants
|
5 Participants
n=6 Participants
|
21 Participants
n=21 Participants
|
19 Participants
n=21 Participants
|
11 Participants
n=13 Participants
|
10 Participants
n=13 Participants
|
70 Participants
n=78 Participants
|
|
Stratification Factor: Screening Serum Parathyroid Hormone (PTH)
< 600 pg/mL
|
3 Participants
n=4 Participants
|
4 Participants
n=6 Participants
|
11 Participants
n=21 Participants
|
12 Participants
n=21 Participants
|
7 Participants
n=13 Participants
|
9 Participants
n=13 Participants
|
46 Participants
n=78 Participants
|
|
Stratification Factor: Screening Serum Parathyroid Hormone (PTH)
≥ 600 pg/mL
|
1 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
10 Participants
n=21 Participants
|
9 Participants
n=21 Participants
|
6 Participants
n=13 Participants
|
4 Participants
n=13 Participants
|
32 Participants
n=78 Participants
|
|
Parathyroid Hormone
|
636.3 pg/mL
STANDARD_DEVIATION 191.64 • n=4 Participants
|
588.3 pg/mL
STANDARD_DEVIATION 250.52 • n=6 Participants
|
601.5 pg/mL
STANDARD_DEVIATION 239.20 • n=21 Participants
|
765.1 pg/mL
STANDARD_DEVIATION 480.82 • n=21 Participants
|
619.4 pg/mL
STANDARD_DEVIATION 310.35 • n=13 Participants
|
662.1 pg/mL
STANDARD_DEVIATION 442.01 • n=13 Participants
|
659.4 pg/mL
STANDARD_DEVIATION 361.28 • n=78 Participants
|
|
Corrected Calcium
|
9.1 mg/dL
STANDARD_DEVIATION 0.84 • n=4 Participants • Corrected calcium data were missing for 2 participants in Cohort 3.
|
9.3 mg/dL
STANDARD_DEVIATION 0.44 • n=6 Participants • Corrected calcium data were missing for 2 participants in Cohort 3.
|
9.8 mg/dL
STANDARD_DEVIATION 0.62 • n=21 Participants • Corrected calcium data were missing for 2 participants in Cohort 3.
|
9.7 mg/dL
STANDARD_DEVIATION 0.59 • n=21 Participants • Corrected calcium data were missing for 2 participants in Cohort 3.
|
9.3 mg/dL
STANDARD_DEVIATION 0.58 • n=12 Participants • Corrected calcium data were missing for 2 participants in Cohort 3.
|
9.7 mg/dL
STANDARD_DEVIATION 0.62 • n=12 Participants • Corrected calcium data were missing for 2 participants in Cohort 3.
|
9.6 mg/dL
STANDARD_DEVIATION 0.63 • n=76 Participants • Corrected calcium data were missing for 2 participants in Cohort 3.
|
|
Phosphorus
|
—
|
—
|
6.5 mg/dL
STANDARD_DEVIATION 1.83 • n=18 Participants • Phosphorus values were not collected at Baseline for Cohort 1; data were missing for 7 participants in Cohort 2 and 2 participants in Cohort 3.
|
5.7 mg/dL
STANDARD_DEVIATION 1.18 • n=17 Participants • Phosphorus values were not collected at Baseline for Cohort 1; data were missing for 7 participants in Cohort 2 and 2 participants in Cohort 3.
|
5.2 mg/dL
STANDARD_DEVIATION 1.17 • n=12 Participants • Phosphorus values were not collected at Baseline for Cohort 1; data were missing for 7 participants in Cohort 2 and 2 participants in Cohort 3.
|
5.0 mg/dL
STANDARD_DEVIATION 1.02 • n=12 Participants • Phosphorus values were not collected at Baseline for Cohort 1; data were missing for 7 participants in Cohort 2 and 2 participants in Cohort 3.
|
5.7 mg/dL
STANDARD_DEVIATION 1.49 • n=59 Participants • Phosphorus values were not collected at Baseline for Cohort 1; data were missing for 7 participants in Cohort 2 and 2 participants in Cohort 3.
|
PRIMARY outcome
Timeframe: Baseline and the efficacy assessment phase (EAP; defined as the period between 3 days before and 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)Population: Modified intent-to-treat population
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
Outcome measures
| Measure |
Cohort 1: Placebo
n=4 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
|
Cohort 1: Etelcalcetide 5 mg
n=6 Participants
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
|
Cohort 2: Placebo
n=21 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 2: Etelcalcetide 10 mg
n=21 Participants
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Placebo
n=13 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Etelcalcetide 5 mg
n=13 Participants
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Mean Pre-hemodialysis Parathyroid Hormone (PTH) During the Efficacy Assessment Phase
|
0.3 percent change
Standard Deviation 17.11
|
-19.4 percent change
Standard Deviation 20.65
|
28.5 percent change
Standard Deviation 70.39
|
-49.4 percent change
Standard Deviation 20.42
|
2.3 percent change
Standard Deviation 29.44
|
-33.0 percent change
Standard Deviation 26.28
|
SECONDARY outcome
Timeframe: Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)Population: Modified intent-to-treat population
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
Outcome measures
| Measure |
Cohort 1: Placebo
n=4 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
|
Cohort 1: Etelcalcetide 5 mg
n=6 Participants
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
|
Cohort 2: Placebo
n=21 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 2: Etelcalcetide 10 mg
n=21 Participants
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Placebo
n=13 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Etelcalcetide 5 mg
n=13 Participants
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With ≥ 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase
|
0.0 percentage of participants
|
33.3 percentage of participants
|
9.5 percentage of participants
|
76.2 percentage of participants
|
15.4 percentage of participants
|
53.8 percentage of participants
|
SECONDARY outcome
Timeframe: Efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)Population: Modified intent-to-treat population
The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
Outcome measures
| Measure |
Cohort 1: Placebo
n=4 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
|
Cohort 1: Etelcalcetide 5 mg
n=6 Participants
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
|
Cohort 2: Placebo
n=21 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 2: Etelcalcetide 10 mg
n=21 Participants
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Placebo
n=13 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Etelcalcetide 5 mg
n=13 Participants
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Mean Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase
|
0.0 percentage of participants
|
16.7 percentage of participants
|
4.8 percentage of participants
|
66.7 percentage of participants
|
7.7 percentage of participants
|
46.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)Population: Modified intent-to-treat population with available data
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
Outcome measures
| Measure |
Cohort 1: Placebo
n=4 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
|
Cohort 1: Etelcalcetide 5 mg
n=6 Participants
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
|
Cohort 2: Placebo
n=21 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 2: Etelcalcetide 10 mg
n=21 Participants
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Placebo
n=12 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Etelcalcetide 5 mg
n=12 Participants
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Mean Corrected Calcium (cCa) During the Efficacy Assessment Phase
|
1.7 percent change
Standard Deviation 3.76
|
-7.3 percent change
Standard Deviation 2.62
|
-1.7 percent change
Standard Deviation 6.25
|
-13.0 percent change
Standard Deviation 10.17
|
1.0 percent change
Standard Deviation 5.26
|
-6.0 percent change
Standard Deviation 7.95
|
SECONDARY outcome
Timeframe: Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)Population: Modified intent-to-treat population with available data; Phosphorus data were not collected at baseline for participants in Cohort 1.
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
Outcome measures
| Measure |
Cohort 1: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
|
Cohort 1: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
|
Cohort 2: Placebo
n=17 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 2: Etelcalcetide 10 mg
n=17 Participants
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Placebo
n=12 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Etelcalcetide 5 mg
n=12 Participants
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Mean Phosphorus (P) During the Efficacy Assessment Phase
|
—
|
—
|
1.4 percent change
Standard Deviation 17.92
|
-2.4 percent change
Standard Deviation 26.86
|
14.1 percent change
Standard Deviation 36.05
|
-7.3 percent change
Standard Deviation 12.83
|
SECONDARY outcome
Timeframe: Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)Population: Modified intent-to-treat population with available data; Phosphorus data were not collected at baseline for participants in Cohort 1.
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
Outcome measures
| Measure |
Cohort 1: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
|
Cohort 1: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
|
Cohort 2: Placebo
n=17 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 2: Etelcalcetide 10 mg
n=17 Participants
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Placebo
n=12 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Etelcalcetide 5 mg
n=12 Participants
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase
|
—
|
—
|
-0.3 percent change
Standard Deviation 16.25
|
-11.0 percent change
Standard Deviation 32.32
|
14.7 percent change
Standard Deviation 35.79
|
-12.6 percent change
Standard Deviation 14.99
|
SECONDARY outcome
Timeframe: Efficacy assessment phasePopulation: Modified intent to treat population
Outcome measures
| Measure |
Cohort 1: Placebo
n=4 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
|
Cohort 1: Etelcalcetide 5 mg
n=6 Participants
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
|
Cohort 2: Placebo
n=21 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 2: Etelcalcetide 10 mg
n=21 Participants
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Placebo
n=13 Participants
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Etelcalcetide 5 mg
n=13 Participants
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Mean Phosphorus ≤ 4.5 mg/dL or ≤ 5.5 mg/dL During the Efficacy Assessment Phase
Phosphorus ≤ 5.5 mg/dL
|
0.0 percentage of participants
|
0.0 percentage of participants
|
33.3 percentage of participants
|
66.7 percentage of participants
|
53.8 percentage of participants
|
76.9 percentage of participants
|
|
Percentage of Participants With Mean Phosphorus ≤ 4.5 mg/dL or ≤ 5.5 mg/dL During the Efficacy Assessment Phase
Phosphorus ≤ 4.5 mg/dL
|
0.0 percentage of participants
|
0.0 percentage of participants
|
4.8 percentage of participants
|
47.6 percentage of participants
|
15.4 percentage of participants
|
46.2 percentage of participants
|
Adverse Events
Cohort 1: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1: Etelcalcetide 5 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2: Placebo
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2: Etelcalcetide 10 mg
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3: Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3: Etelcalcetide 5 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Placebo
n=4 participants at risk
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
|
Cohort 1: Etelcalcetide 5 mg
n=6 participants at risk
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
|
Cohort 2: Placebo
n=21 participants at risk
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 2: Etelcalcetide 10 mg
n=21 participants at risk
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Placebo
n=13 participants at risk
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Etelcalcetide 5 mg
n=13 participants at risk
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
1/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
1/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
1/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
1/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
1/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
1/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
1/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
1/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
1/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
1/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Cohort 1: Placebo
n=4 participants at risk
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
|
Cohort 1: Etelcalcetide 5 mg
n=6 participants at risk
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
|
Cohort 2: Placebo
n=21 participants at risk
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 2: Etelcalcetide 10 mg
n=21 participants at risk
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Placebo
n=13 participants at risk
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
Cohort 3: Etelcalcetide 5 mg
n=13 participants at risk
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
1/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
1/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
15.4%
2/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
1/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
1/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
1/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
25.0%
1/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
1/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.3%
3/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
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
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
1/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
1/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
1/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
1/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
1/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
1/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
1/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
1/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
1/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urine odour abnormal
|
25.0%
1/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
1/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
1/21 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
1/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/13 • From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
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