Evaluating the Safety and Efficacy of Romiplostim (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT00111475
Collaborator
(none)
45
10
23.6
Study Details
Study Description
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with ITP.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
45 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Part A was a sequential cohort dose escalation study. Part B was a randomized, placebo-controlled parallel group study.Part A was a sequential cohort dose escalation study. Part B was a randomized, placebo-controlled parallel group study.
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Dose-finding Study Evaluating the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
Actual Study Start Date
:
Jul 1, 2002
Actual Primary Completion Date
:
Jun 17, 2004
Actual Study Completion Date
:
Jun 17, 2004
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part A: Romiplostim 0.2 µg/kg Participants received 0.2 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. |
Drug: Romiplostim
Administered by subcutaneous injection
Other Names:
|
| Experimental: Part A: Romiplostim 0.5 µg/kg Participants received 0.5 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. |
Drug: Romiplostim
Administered by subcutaneous injection
Other Names:
|
| Experimental: Part A: Romiplostim 1.0 µg/kg Participants received 1.0 µg/kg romiplostim subcutaneously on day 1 and on day 15 or 22 depending on platelet counts. |
Drug: Romiplostim
Administered by subcutaneous injection
Other Names:
|
| Experimental: Part A: Romiplostim 3 µg/kg Participants received 3.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. |
Drug: Romiplostim
Administered by subcutaneous injection
Other Names:
|
| Experimental: Part A: Romiplostim 6 µg/kg Participants received 6.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. |
Drug: Romiplostim
Administered by subcutaneous injection
Other Names:
|
| Experimental: Part A: Romiplostim 10 µg/kg Participants received 10.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. |
Drug: Romiplostim
Administered by subcutaneous injection
Other Names:
|
| Placebo Comparator: Part B: Placebo Participants received placebo subcutaneously once a week for 6 weeks. |
Drug: Placebo
Administered by subcutaneous injection
|
| Experimental: Part B: Romiplostim 1.0 µg/kg Participants received 1.0 µg/kg subcutaneously once a week for 6 weeks. |
Drug: Romiplostim
Administered by subcutaneous injection
Other Names:
|
| Experimental: Part B: Romiplostim 3.0 µg/kg Participants received 3.0 µg/kg subcutaneously once a week for 6 weeks. |
Drug: Romiplostim
Administered by subcutaneous injection
Other Names:
|
| Experimental: Part B: Romiplostim 6.0 µg/kg Participants received 6.0 µg/kg subcutaneously once a week for 6 weeks. |
Drug: Romiplostim
Administered by subcutaneous injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events [From first dose of study drug through 8 weeks (Part A) or 6 weeks (Part B) after last dose of study drug; 78 days]
- Number of Participants With Anti-romiplostim or Anti-endogenous Thrombopoietin Neutralizing Antibodies [Assessed on day 29 (Part A only), day 43 (Part B only), and day 78]
The development of antibodies to romiplostim or to endogenous thrombopoietin (eTPO) was assessed using a neutralizing bioassay. Participants positive for neutralizing antibodies at any of the assessments during the study are reported.
Secondary Outcome Measures
- Number of Participants Who Achieved Targeted Therapeutic Platelet Level in Part A [After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)]
Targeted therapeutic platelet level was defined as a doubling of baseline platelet counts and between 50 to 450 x 10⁹ cells/L. Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.
- Number of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L Over Baseline in Part A [After first dose (day 1 to day 15 or 22), and after second dose (day 15 or 22 to day 78)]
Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.
- Number of Participants With a Peak Platelet Count ≥ 100 x 10⁹ Cells/L in Part A [After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)]
Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.
- Number of Participants With a Peak Platelet Count of > 450 x 10⁹ Cells/L in Part A [After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)]
Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.
- Peak Platelet Count After Each Dose in Part A [After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)]
Platelet count data after the use of rescue medication were not included.
- Change From Baseline in Peak Platelet Count After Each Dose in Part A [Baseline and after first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)]
Platelet count data after the use of rescue medication were not included.
- Time to Peak Platelet Count After Each Dose in Part A [After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)]
Platelet count data after the use of rescue medication were not included.
- Duration Within the Targeted Therapeutic Platelet Range In Part A [After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)]
Targeted therapeutic platelet level was defined as a platelet count that was double the baseline level and ≥ 50 and ≤ 450 × 10⁹ cells/L. Platelet count data after the use of rescue medication were not included.
- Percentage of Participants Who Achieved Targeted Therapeutic Platelet Level In Part B [Day 1 to day 78]
Targeted therapeutic platelet level was defined as a doubling of baseline platelet counts and within the range of greater than or equal to 50 x 10⁹ cells/L and less than or equal to 450 x 10⁹ cells/L. Platelet count data after use of rescue medication were not included in the analysis.
- Percentage of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L Over Baseline in Part B [Day 1 to day 78]
Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders.
- Percentage of Participants With a Peak Platelet Count of ≥ 100 x 10⁹ Cells/L in Part B [Day 1 to day 78]
Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders.
- Percentage of Participants With a Peak Platelet Count of > 450 x 10⁹ Cells/L in Part B [Day 1 to day 78]
Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders.
- Percentage of Participants With a Peak Platelet Count of > 500 x 10⁹ Cells/L in Part B [Day 1 to day 78]
Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders.
- Peak Platelet Count in Part B [Day 1 to day 78]
Platelet count data after administration of rescue medication were not included in the analysis.
- Change From Baseline in Peak Platelet Count in Part B [Baseline and day 1 to day 78]
Platelet count data after administration of rescue medication were not included in the analysis.
- Time to Peak Platelet Count in Part B [Day 1 to day 78]
Platelet count data after administration of rescue medication were not included in the analysis. Time to peak platelet count was analyzed using the Kaplan-Meier method.
- Duration Within the Targeted Therapeutic Platelet Range in Part B [Day 1 to day 78]
Targeted therapeutic platelet level was defined as a doubling of baseline platelet counts and within the range of greater than or equal to 50 × 10⁹ cells/L and less than or equal to 450 × 10⁹ cells/L. Platelet count data after administration of rescue medication were not included in the analysis.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosis of ITP according to American Society of Hematology (ASH) guidelines at least 3 months before enrollment
-
Have completed at least 1 prior treatment for ITP
-
Two (including day -2) of the 3 platelet counts taken during the screening and pre-treatment periods must have fulfilled the following:
-
less than 30 x 10^9/L for those subjects not receiving any ITP therapy,
-
less than 50 x 10^9/L for those subjects receiving any ITP therapy
-
Eastern Cooperative Oncology Group performance status of 0 to 2
-
Serum creatinine concentration ≤ 2 mg/dL (≤ 176.8 µmol/L)
-
Adequate liver function, as evidenced by a serum bilirubin ≤ 1.5 times the laboratory normal range
-
Hemoglobin greater than 10.0 g/dL
-
Written informed consent
Exclusion Criteria:
-
Considered a substantial risk for adverse outcomes because of a clinically important trend (as determined by the investigator) detected in the platelet counts during the screening period
-
Any known history of bone marrow stem cell disorder
-
Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years before randomization
-
Documented diagnosis of arterial thrombosis (ie, stroke, transient ischemic attack, or myocardial infarction) in the previous year; history of venous thrombosis (ie, deep vein thrombosis, pulmonary embolism) and receiving anticoagulation therapy
-
Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure [New York Heart Association (NYHA) greater than class II], uncontrolled hypertension [diastolic greater than 100 mmHg] or cardiac arrhythmia)
-
Have 3 or more of the following predisposing factors for thromboembolic events: diabetes; smoker using oral contraceptives; hypercholesteremia (> 240 mg/dL); treatment for hypertension
-
Known positive test for human immunodeficiency virus (HIV) infection or hepatitis C virus
-
Received any treatment for ITP (except for a constant dose schedule of corticosteroids) within 4 weeks before the screening visit
-
Received intravenous (IV) immunoglobulin (Ig) or WinRho within 2 weeks before the screening visit
-
Received hematopoietic growth factors, including interleukin (IL)-11 (Neumega®) within 4 weeks before the screening visit
-
Past or present participation in any study evaluating polyethylene glycol recombinant human magakaryopoiesis differentiating factor (PEG-rHuMGDF), recombinant human thrombopoietin (rHuTPO), or related platelet product
-
Received any alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study
-
Received any monoclonal antibody (eg, rituximab) within 16 weeks before the screening visit or anticipated use during the time of the proposed study
-
Less than 4 weeks since receipt of any therapeutic drug or device that is not FDA approved for any indication before the screening period
-
Less than 2 months since major surgery (including laparoscopic splenectomy)
-
Pregnant or breast feeding
-
Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- AmgenTrials clinical trials website
- Notice regarding posted summaries of trial results
- To access clinical trial results information click on this link
- FDA-approved Drug Labeling
Publications
- Bussel JB, Kuter DJ, George JN, McMillan R, Aledort LM, Conklin GT, Lichtin AE, Lyons RM, Nieva J, Wasser JS, Wiznitzer I, Kelly R, Chen CF, Nichol JL. AMG 531, a thrombopoiesis-stimulating protein, for chronic ITP. N Engl J Med. 2006 Oct 19;355(16):1672-81. Erratum in: N Engl J Med. 2006 Nov 9;355(19):2054.
- Cines DB, Wasser J, Rodeghiero F, Chong BH, Steurer M, Provan D, Lyons R, Garcia-Chavez J, Carpenter N, Wang X, Eisen M. Safety and efficacy of romiplostim in splenectomized and nonsplenectomized patients with primary immune thrombocytopenia. Haematologica. 2017 Aug;102(8):1342-1351. doi: 10.3324/haematol.2016.161968. Epub 2017 Apr 14.
Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT00111475
Other Study ID Numbers:
- 20000137
First Posted:
May 23, 2005
Last Update Posted:
Jan 10, 2020
Last Verified:
Dec 1, 2019
Keywords provided by Amgen
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | This study consisted of 2 parts. Part A (conducted from July 1, 2002 to October 13, 2003) was an open-label, dose-escalation trial with sequential cohorts of participants. Part B (conducted from October 6, 2003 to June 17, 2004) was a double-blind, placebo-controlled, parallel design study. |
|---|---|
| Pre-assignment Detail | In Part A participants were sequentially assigned to escalating dose cohorts. In Part B, participants were randomized to each dose cohort; within each cohort 2 of 10 participants were randomly assigned to receive placebo. The 6.0 µg/kg dose cohort was discontinued in protocol amendment 4. |
| Arm/Group Title | Part A: Romiplostim 0.2 µg/kg | Part A: Romiplostim 0.5 µg/kg | Part A: Romiplostim 1.0 µg/kg | Part A: Romiplostim 3 µg/kg | Part A: Romiplostim 6 µg/kg | Part A: Romiplostim 10 µg/kg | Part B: Placebo | Part B: Romiplostim 1.0 µg/kg | Part B: Romiplostim 3.0 µg/kg | Part B: Romiplostim 6.0 µg/kg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts | Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts. | Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received placebo by subcutaneous injection once a week for 6 weeks. | Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. |
| Period Title: Overall Study | ||||||||||
| STARTED | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 8 | 8 | 1 |
| COMPLETED | 4 | 4 | 4 | 4 | 4 | 3 | 4 | 8 | 8 | 1 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Part A: Romiplostim 0.2 µg/kg | Part A: Romiplostim 0.5 µg/kg | Part A: Romiplostim 1.0 µg/kg | Part A: Romiplostim 3 µg/kg | Part A: Romiplostim 6 µg/kg | Part A: Romiplostim 10 µg/kg | Part B: Placebo | Part B: Romiplostim 1.0 µg/kg | Part B: Romiplostim 3.0 µg/kg | Part B: Romiplostim 6.0 µg/kg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts | Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts. | Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received placebo by subcutaneous injection once a week for 6 weeks. | Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Total of all reporting groups |
| Overall Participants | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 8 | 8 | 1 | 45 |
| Age (years) [Mean (Standard Deviation) ] | |||||||||||
| Part A |
43.5
(15.0)
|
42.8
(11.1)
|
42.5
(10.7)
|
44.8
(18.2)
|
41.3
(14.7)
|
47.5
(14.5)
|
43.7
(12.8)
|
||||
| Part B |
53.0
(10.6)
|
43.0
(15.0)
|
47.4
(16.6)
|
42.0
(NA)
|
14.3
(49.0)
|
||||||
| Sex: Female, Male (Count of Participants) | |||||||||||
| Female |
3
75%
|
1
25%
|
4
100%
|
4
100%
|
3
75%
|
2
50%
|
3
75%
|
6
75%
|
5
62.5%
|
1
100%
|
32
71.1%
|
| Male |
1
25%
|
3
75%
|
0
0%
|
0
0%
|
1
25%
|
2
50%
|
1
25%
|
2
25%
|
3
37.5%
|
0
0%
|
13
28.9%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||||||||
| White |
4
100%
|
4
100%
|
4
100%
|
4
100%
|
3
75%
|
3
75%
|
3
75%
|
5
62.5%
|
5
62.5%
|
1
100%
|
36
80%
|
| Black |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
1
25%
|
0
0%
|
1
12.5%
|
0
0%
|
0
0%
|
3
6.7%
|
| Hispanic |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
2
25%
|
3
37.5%
|
0
0%
|
6
13.3%
|
| Plateleet Count (1 × 10⁹ cells/L) [Mean (Standard Deviation) ] | |||||||||||
| Part A |
10.7
(2.70)
|
14.5
(12.5)
|
9.06
(4.19)
|
13.4
(6.81)
|
12.6
(9.00)
|
18.4
(10.1)
|
13.1
(7.93)
|
||||
| Part B |
28.4
(17.7)
|
16.9
(7.86)
|
14.0
(6.20)
|
15.0
(NA)
|
17.9
(10.6)
|
||||||
Outcome Measures
| Title | Number of Participants With Adverse Events |
|---|---|
| Description | |
| Time Frame | From first dose of study drug through 8 weeks (Part A) or 6 weeks (Part B) after last dose of study drug; 78 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants |
| Arm/Group Title | Part A: Romiplostim 0.2 µg/kg | Part A: Romiplostim 0.5 µg/kg | Part A: Romiplostim 1.0 µg/kg | Part A: Romiplostim 3 µg/kg | Part A: Romiplostim 6 µg/kg | Part A: Romiplostim 10 µg/kg | Part B: Placebo | Part B: Romiplostim 1.0 µg/kg | Part B: Romiplostim 3.0 µg/kg | Part B: Romiplostim 6.0 µg/kg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts | Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts. | Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received placebo by subcutaneous injection once a week for 6 weeks. | Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. |
| Measure Participants | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 8 | 8 | 1 |
| Any adverse event |
4
100%
|
4
100%
|
4
100%
|
4
100%
|
4
100%
|
4
100%
|
4
100%
|
8
100%
|
8
100%
|
1
100%
|
| Serious adverse events |
2
50%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
2
50%
|
0
0%
|
1
12.5%
|
0
0%
|
| Treatment-related adverse events |
0
0%
|
0
0%
|
3
75%
|
0
0%
|
1
25%
|
1
25%
|
1
25%
|
2
25%
|
4
50%
|
0
0%
|
| Treatment-related serious adverse events |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
0
0%
|
0
0%
|
1
12.5%
|
0
0%
|
| Discontinuations due to adverse events |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Deaths |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Anti-romiplostim or Anti-endogenous Thrombopoietin Neutralizing Antibodies |
|---|---|
| Description | The development of antibodies to romiplostim or to endogenous thrombopoietin (eTPO) was assessed using a neutralizing bioassay. Participants positive for neutralizing antibodies at any of the assessments during the study are reported. |
| Time Frame | Assessed on day 29 (Part A only), day 43 (Part B only), and day 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants |
| Arm/Group Title | Part A: Romiplostim 0.2 µg/kg | Part A: Romiplostim 0.5 µg/kg | Part A: Romiplostim 1.0 µg/kg | Part A: Romiplostim 3 µg/kg | Part A: Romiplostim 6 µg/kg | Part A: Romiplostim 10 µg/kg | Part B: Placebo | Part B: Romiplostim 1.0 µg/kg | Part B: Romiplostim 3.0 µg/kg | Part B: Romiplostim 6.0 µg/kg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts | Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts. | Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received placebo by subcutaneous injection once a week for 6 weeks. | Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. |
| Measure Participants | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 8 | 8 | 1 |
| Anti-romiplostim neutralizing antibodies |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Anti-eTPO neutralizing antibodies |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants Who Achieved Targeted Therapeutic Platelet Level in Part A |
|---|---|
| Description | Targeted therapeutic platelet level was defined as a doubling of baseline platelet counts and between 50 to 450 x 10⁹ cells/L. Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders. |
| Time Frame | After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants enrolled in Part A who received each dose of romiplostim. |
| Arm/Group Title | Part A: Romiplostim 0.2 µg/kg | Part A: Romiplostim 0.5 µg/kg | Part A: Romiplostim 1.0 µg/kg | Part A: Romiplostim 3 µg/kg | Part A: Romiplostim 6 µg/kg | Part A: Romiplostim 10 µg/kg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts | Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts. | Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| Measure Participants | 4 | 4 | 4 | 4 | 4 | 4 |
| After first dose |
1
25%
|
0
0%
|
0
0%
|
1
25%
|
1
25%
|
1
25%
|
| After second dose |
1
25%
|
0
0%
|
0
0%
|
2
50%
|
1
25%
|
1
25%
|
| After both doses |
1
25%
|
0
0%
|
0
0%
|
1
25%
|
1
25%
|
1
25%
|
| Title | Number of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L Over Baseline in Part A |
|---|---|
| Description | Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders. |
| Time Frame | After first dose (day 1 to day 15 or 22), and after second dose (day 15 or 22 to day 78) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants enrolled in Part A who received each dose of romiplostim |
| Arm/Group Title | Part A: Romiplostim 0.2 µg/kg | Part A: Romiplostim 0.5 µg/kg | Part A: Romiplostim 1.0 µg/kg | Part A: Romiplostim 3 µg/kg | Part A: Romiplostim 6 µg/kg | Part A: Romiplostim 10 µg/kg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts | Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts. | Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| Measure Participants | 4 | 4 | 4 | 4 | 4 | 4 |
| After first dose |
1
25%
|
1
25%
|
1
25%
|
2
50%
|
2
50%
|
3
75%
|
| After second dose |
1
25%
|
0
0%
|
0
0%
|
3
75%
|
1
25%
|
1
25%
|
| After both doses |
1
25%
|
0
0%
|
0
0%
|
2
50%
|
1
25%
|
1
25%
|
| Title | Number of Participants With a Peak Platelet Count ≥ 100 x 10⁹ Cells/L in Part A |
|---|---|
| Description | Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders. |
| Time Frame | After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants enrolled in Part A who received each dose of romiplostim |
| Arm/Group Title | Part A: Romiplostim 0.2 µg/kg | Part A: Romiplostim 0.5 µg/kg | Part A: Romiplostim 1.0 µg/kg | Part A: Romiplostim 3 µg/kg | Part A: Romiplostim 6 µg/kg | Part A: Romiplostim 10 µg/kg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts | Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts. | Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| Measure Participants | 4 | 4 | 4 | 4 | 4 | 4 |
| After first dose |
1
25%
|
0
0%
|
0
0%
|
1
25%
|
2
50%
|
3
75%
|
| After second dose |
0
0%
|
0
0%
|
0
0%
|
2
50%
|
1
25%
|
1
25%
|
| After both doses |
0
0%
|
0
0%
|
0
0%
|
1
25%
|
1
25%
|
1
25%
|
| Title | Number of Participants With a Peak Platelet Count of > 450 x 10⁹ Cells/L in Part A |
|---|---|
| Description | Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders. |
| Time Frame | After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants enrolled in Part A who received each dose of romiplostim |
| Arm/Group Title | Part A: Romiplostim 0.2 µg/kg | Part A: Romiplostim 0.5 µg/kg | Part A: Romiplostim 1.0 µg/kg | Part A: Romiplostim 3 µg/kg | Part A: Romiplostim 6 µg/kg | Part A: Romiplostim 10 µg/kg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts | Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts. | Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| Measure Participants | 4 | 4 | 4 | 4 | 4 | 4 |
| After first dose |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
2
50%
|
| After second dose |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| After both doses |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Peak Platelet Count After Each Dose in Part A |
|---|---|
| Description | Platelet count data after the use of rescue medication were not included. |
| Time Frame | After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants enrolled in Part A who received each dose of romiplostim and with a platelet count of ≥ 50 × 10⁹ cells/L and a doubling of the baseline platelet count, in the absence of rescue medication. |
| Arm/Group Title | Part A: Romiplostim 0.2 µg/kg | Part A: Romiplostim 0.5 µg/kg | Part A: Romiplostim 1.0 µg/kg | Part A: Romiplostim 3 µg/kg | Part A: Romiplostim 6 µg/kg | Part A: Romiplostim 10 µg/kg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts | Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts. | Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| Measure Participants | 1 | 0 | 0 | 2 | 2 | 3 |
| After first dose |
123.0
|
163.0
|
309.0
(202.2)
|
746.3
(611.9)
|
||
| After second dose |
65.0
|
140.5
(29.0)
|
244.0
|
259.0
|
| Title | Change From Baseline in Peak Platelet Count After Each Dose in Part A |
|---|---|
| Description | Platelet count data after the use of rescue medication were not included. |
| Time Frame | Baseline and after first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants enrolled in Part A who received each dose of romiplostim and with a platelet count of ≥ 50 × 10⁹ cells/L and a doubling of the baseline platelet count, in the absence of rescue medication. |
| Arm/Group Title | Part A: Romiplostim 0.2 µg/kg | Part A: Romiplostim 0.5 µg/kg | Part A: Romiplostim 1.0 µg/kg | Part A: Romiplostim 3 µg/kg | Part A: Romiplostim 6 µg/kg | Part A: Romiplostim 10 µg/kg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts | Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts. | Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| Measure Participants | 1 | 0 | 0 | 2 | 2 | 3 |
| After first dose |
109.5
|
150.2
|
289.3
(208.2)
|
725.5
(622.5)
|
||
| After second dose |
51.50
|
122.6
(21.78)
|
220.0
|
231.7
|
| Title | Time to Peak Platelet Count After Each Dose in Part A |
|---|---|
| Description | Platelet count data after the use of rescue medication were not included. |
| Time Frame | After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants enrolled in Part A who received each dose of romiplostim and with a platelet count of ≥ 50 × 10⁹ cells/L and a doubling of the baseline platelet count, in the absence of rescue medication. |
| Arm/Group Title | Part A: Romiplostim 0.2 µg/kg | Part A: Romiplostim 0.5 µg/kg | Part A: Romiplostim 1.0 µg/kg | Part A: Romiplostim 3 µg/kg | Part A: Romiplostim 6 µg/kg | Part A: Romiplostim 10 µg/kg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts | Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts. | Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| Measure Participants | 1 | 0 | 0 | 2 | 2 | 3 |
| After first dose |
10.0
|
11.0
|
9.5
|
15.0
|
||
| After second dose |
10.0
|
11.0
|
10.0
|
11.0
|
| Title | Duration Within the Targeted Therapeutic Platelet Range In Part A |
|---|---|
| Description | Targeted therapeutic platelet level was defined as a platelet count that was double the baseline level and ≥ 50 and ≤ 450 × 10⁹ cells/L. Platelet count data after the use of rescue medication were not included. |
| Time Frame | After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants enrolled in Part A who received each dose of romiplostim and with a platelet count ≥ 50 × 10⁹ cells/L and ≤ 450 × 10⁹ cells/L and a doubling of the baseline platelet count, in the absence of rescue medication. |
| Arm/Group Title | Part A: Romiplostim 0.2 µg/kg | Part A: Romiplostim 0.5 µg/kg | Part A: Romiplostim 1.0 µg/kg | Part A: Romiplostim 3 µg/kg | Part A: Romiplostim 6 µg/kg | Part A: Romiplostim 10 µg/kg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts | Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts. | Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| Measure Participants | 1 | 0 | 0 | 2 | 1 | 1 |
| After first dose |
5.0
|
8.0
|
11.0
|
10.0
|
||
| After second dose |
3.0
|
3.5
(2.1)
|
11.0
|
9.0
|
| Title | Percentage of Participants Who Achieved Targeted Therapeutic Platelet Level In Part B |
|---|---|
| Description | Targeted therapeutic platelet level was defined as a doubling of baseline platelet counts and within the range of greater than or equal to 50 x 10⁹ cells/L and less than or equal to 450 x 10⁹ cells/L. Platelet count data after use of rescue medication were not included in the analysis. |
| Time Frame | Day 1 to day 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants randomized in Part B who received at least 1 dose of study drug. |
| Arm/Group Title | Part B: Placebo | Part B: Romiplostim 1.0 µg/kg | Part B: Romiplostim 3.0 µg/kg | Part B: Romiplostim 6.0 µg/kg |
|---|---|---|---|---|
| Arm/Group Description | Participants received placebo by subcutaneous injection once a week for 6 weeks. | Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. |
| Measure Participants | 4 | 8 | 8 | 1 |
| Number [percentage of participants] |
25
625%
|
88
2200%
|
38
950%
|
0
0%
|
| Title | Percentage of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L Over Baseline in Part B |
|---|---|
| Description | Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders. |
| Time Frame | Day 1 to day 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants randomized in Part B who received at least 1 dose of study drug. |
| Arm/Group Title | Part B: Placebo | Part B: Romiplostim 1.0 µg/kg | Part B: Romiplostim 3.0 µg/kg | Part B: Romiplostim 6.0 µg/kg |
|---|---|---|---|---|
| Arm/Group Description | Participants received placebo by subcutaneous injection once a week for 6 weeks. | Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. |
| Measure Participants | 4 | 8 | 8 | 1 |
| Number [percentage of participants] |
50
1250%
|
100
2500%
|
75
1875%
|
100
2500%
|
| Title | Percentage of Participants With a Peak Platelet Count of ≥ 100 x 10⁹ Cells/L in Part B |
|---|---|
| Description | Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders. |
| Time Frame | Day 1 to day 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants randomized in Part B who received at least 1 dose of study drug. |
| Arm/Group Title | Part B: Placebo | Part B: Romiplostim 1.0 µg/kg | Part B: Romiplostim 3.0 µg/kg | Part B: Romiplostim 6.0 µg/kg |
|---|---|---|---|---|
| Arm/Group Description | Participants received placebo by subcutaneous injection once a week for 6 weeks. | Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. |
| Measure Participants | 4 | 8 | 8 | 1 |
| Number [percentage of participants] |
25
625%
|
63
1575%
|
63
1575%
|
100
2500%
|
| Title | Percentage of Participants With a Peak Platelet Count of > 450 x 10⁹ Cells/L in Part B |
|---|---|
| Description | Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders. |
| Time Frame | Day 1 to day 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants randomized in Part B who received at least 1 dose of study drug. |
| Arm/Group Title | Part B: Placebo | Part B: Romiplostim 1.0 µg/kg | Part B: Romiplostim 3.0 µg/kg | Part B: Romiplostim 6.0 µg/kg |
|---|---|---|---|---|
| Arm/Group Description | Participants received placebo by subcutaneous injection once a week for 6 weeks. | Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. |
| Measure Participants | 4 | 8 | 8 | 1 |
| Number [percentage of participants] |
0
0%
|
0
0%
|
25
625%
|
100
2500%
|
| Title | Percentage of Participants With a Peak Platelet Count of > 500 x 10⁹ Cells/L in Part B |
|---|---|
| Description | Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders. |
| Time Frame | Day 1 to day 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants randomized in Part B who received at least 1 dose of study drug. |
| Arm/Group Title | Part B: Placebo | Part B: Romiplostim 1.0 µg/kg | Part B: Romiplostim 3.0 µg/kg | Part B: Romiplostim 6.0 µg/kg |
|---|---|---|---|---|
| Arm/Group Description | Participants received placebo by subcutaneous injection once a week for 6 weeks. | Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks |
| Measure Participants | 4 | 8 | 8 | 1 |
| Number [percentage of participants] |
0
0%
|
0
0%
|
25
625%
|
100
2500%
|
| Title | Peak Platelet Count in Part B |
|---|---|
| Description | Platelet count data after administration of rescue medication were not included in the analysis. |
| Time Frame | Day 1 to day 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants randomized in Part B who received at least 1 dose of study drug. |
| Arm/Group Title | Part B: Placebo | Part B: Romiplostim 1.0 µg/kg | Part B: Romiplostim 3.0 µg/kg | Part B: Romiplostim 6.0 µg/kg |
|---|---|---|---|---|
| Arm/Group Description | Participants received placebo by subcutaneous injection once a week for 6 weeks. | Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. |
| Measure Participants | 4 | 8 | 8 | 1 |
| Mean (Standard Deviation) [1 × 10⁹ cells/L] |
80.8
(96.0)
|
134.5
(90.2)
|
240.9
(288.3)
|
520.0
|
| Title | Change From Baseline in Peak Platelet Count in Part B |
|---|---|
| Description | Platelet count data after administration of rescue medication were not included in the analysis. |
| Time Frame | Baseline and day 1 to day 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants randomized in Part B who received at least 1 dose of study drug. |
| Arm/Group Title | Part B: Placebo | Part B: Romiplostim 1.0 µg/kg | Part B: Romiplostim 3.0 µg/kg | Part B: Romiplostim 6.0 µg/kg |
|---|---|---|---|---|
| Arm/Group Description | Participants received placebo by subcutaneous injection once a week for 6 weeks. | Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks |
| Measure Participants | 4 | 8 | 8 | 1 |
| Mean (Standard Deviation) [1 × 10⁹ cells/L] |
52.4
(92.9)
|
117.6
(88.3)
|
226.9
(284.1)
|
505.0
|
| Title | Time to Peak Platelet Count in Part B |
|---|---|
| Description | Platelet count data after administration of rescue medication were not included in the analysis. Time to peak platelet count was analyzed using the Kaplan-Meier method. |
| Time Frame | Day 1 to day 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants randomized in Part B who received at least 1 dose of study drug. |
| Arm/Group Title | Part B: Placebo | Part B: Romiplostim 1.0 µg/kg | Part B: Romiplostim 3.0 µg/kg | Part B: Romiplostim 6.0 µg/kg |
|---|---|---|---|---|
| Arm/Group Description | Participants received placebo by subcutaneous injection once a week for 6 weeks. | Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. |
| Measure Participants | 4 | 8 | 8 | 1 |
| Median (Inter-Quartile Range) [days] |
63
|
18
|
19
|
21
|
| Title | Duration Within the Targeted Therapeutic Platelet Range in Part B |
|---|---|
| Description | Targeted therapeutic platelet level was defined as a doubling of baseline platelet counts and within the range of greater than or equal to 50 × 10⁹ cells/L and less than or equal to 450 × 10⁹ cells/L. Platelet count data after administration of rescue medication were not included in the analysis. |
| Time Frame | Day 1 to day 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants randomized in Part B who received at least 1 dose of study drug and achieved a targeted therapeutic platelet level. |
| Arm/Group Title | Part B: Placebo | Part B: Romiplostim 1.0 µg/kg | Part B: Romiplostim 3.0 µg/kg | Part B: Romiplostim 6.0 µg/kg |
|---|---|---|---|---|
| Arm/Group Description | Participants received placebo by subcutaneous injection once a week for 6 weeks. | Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. |
| Measure Participants | 1 | 7 | 5 | 1 |
| Median (Full Range) [weeks] |
6.0
|
3.0
|
5.0
|
4.0
|
Adverse Events
| Time Frame | From first dose of study drug through 8 weeks (Part A) or 6 weeks (Part B) after last dose of study drug; 78 days. | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. | |||||||||||||||||||
| Arm/Group Title | Part A: Romiplostim 0.2 µg/kg | Part A: Romiplostim 0.5 µg/kg | Part A: Romiplostim 1.0 µg/kg | Part A: Romiplostim 3 µg/kg | Part A: Romiplostim 6 µg/kg | Part A: Romiplostim 10 µg/kg | Part B: Placebo | Part B: Romiplostim 1.0 µg/kg | Part B: Romiplostim 3.0 µg/kg | Part B: Romiplostim 6.0 µg/kg | ||||||||||
| Arm/Group Description | Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts. | Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | Participants received placebo by subcutaneous injection once a week for 6 weeks. | Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | ||||||||||
All Cause Mortality |
||||||||||||||||||||
| Part A: Romiplostim 0.2 µg/kg | Part A: Romiplostim 0.5 µg/kg | Part A: Romiplostim 1.0 µg/kg | Part A: Romiplostim 3 µg/kg | Part A: Romiplostim 6 µg/kg | Part A: Romiplostim 10 µg/kg | Part B: Placebo | Part B: Romiplostim 1.0 µg/kg | Part B: Romiplostim 3.0 µg/kg | Part B: Romiplostim 6.0 µg/kg | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||||
Serious Adverse Events |
||||||||||||||||||||
| Part A: Romiplostim 0.2 µg/kg | Part A: Romiplostim 0.5 µg/kg | Part A: Romiplostim 1.0 µg/kg | Part A: Romiplostim 3 µg/kg | Part A: Romiplostim 6 µg/kg | Part A: Romiplostim 10 µg/kg | Part B: Placebo | Part B: Romiplostim 1.0 µg/kg | Part B: Romiplostim 3.0 µg/kg | Part B: Romiplostim 6.0 µg/kg | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/4 (50%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 2/4 (50%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||
| Thrombocytopenia | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Ear and labyrinth disorders | ||||||||||||||||||||
| Vertigo | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||
| Rectal haemorrhage | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||
| Contusion | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Nervous system disorders | ||||||||||||||||||||
| Cerebral haemorrhage | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Haemorrhage intracranial | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Reproductive system and breast disorders | ||||||||||||||||||||
| Vaginal haemorrhage | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||
| Asthma | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Vascular disorders | ||||||||||||||||||||
| Deep vein thrombosis | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||
| Part A: Romiplostim 0.2 µg/kg | Part A: Romiplostim 0.5 µg/kg | Part A: Romiplostim 1.0 µg/kg | Part A: Romiplostim 3 µg/kg | Part A: Romiplostim 6 µg/kg | Part A: Romiplostim 10 µg/kg | Part B: Placebo | Part B: Romiplostim 1.0 µg/kg | Part B: Romiplostim 3.0 µg/kg | Part B: Romiplostim 6.0 µg/kg | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/4 (100%) | 4/4 (100%) | 4/4 (100%) | 4/4 (100%) | 4/4 (100%) | 4/4 (100%) | 4/4 (100%) | 8/8 (100%) | 8/8 (100%) | 1/1 (100%) | ||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||
| Anaemia | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Idiopathic thrombocytopenic purpura | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Thrombocytopenia | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/8 (12.5%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Cardiac disorders | ||||||||||||||||||||
| Tachycardia | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Ear and labyrinth disorders | ||||||||||||||||||||
| Ear haemorrhage | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Eye disorders | ||||||||||||||||||||
| Eye haemorrhage | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Retinal haemorrhage | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Vision blurred | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||
| Abdominal discomfort | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Abdominal pain | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 1/8 (12.5%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Abdominal pain upper | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Aphthous stomatitis | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Constipation | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Diarrhoea | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/8 (0%) | 2/8 (25%) | 1/1 (100%) | ||||||||||
| Faeces discoloured | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Flatulence | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Gastrooesophageal reflux disease | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Gingival bleeding | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) | 1/4 (25%) | 0/8 (0%) | 4/8 (50%) | 0/1 (0%) | ||||||||||
| Haematochezia | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 2/8 (25%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Loose stools | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Mouth haemorrhage | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Mouth ulceration | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Nausea | 1/4 (25%) | 0/4 (0%) | 2/4 (50%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/8 (0%) | 2/8 (25%) | 0/1 (0%) | ||||||||||
| Oesophageal spasm | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Oral mucosal blistering | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 1/8 (12.5%) | 3/8 (37.5%) | 1/1 (100%) | ||||||||||
| Oral mucosal petechiae | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Rectal haemorrhage | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Stomach discomfort | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Stomatitis | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 2/4 (50%) | 1/8 (12.5%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Tongue haemorrhage | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Toothache | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Vomiting | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| General disorders | ||||||||||||||||||||
| Asthenia | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Chills | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Fatigue | 1/4 (25%) | 2/4 (50%) | 2/4 (50%) | 1/4 (25%) | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Fibrosis | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Injection site haemorrhage | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 1/4 (25%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Injection site pain | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Oedema peripheral | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Pain | 0/4 (0%) | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Pyrexia | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Venipuncture site bruise | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 2/8 (25%) | 0/1 (0%) | ||||||||||
| Infections and infestations | ||||||||||||||||||||
| Acute sinusitis | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Fungal infection | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 1/1 (100%) | ||||||||||
| Herpes simplex | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 2/8 (25%) | 0/1 (0%) | ||||||||||
| Laryngitis | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Nasopharyngitis | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Sinusitis | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Tooth abscess | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Upper respiratory tract infection | 2/4 (50%) | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) | 2/4 (50%) | 0/4 (0%) | 1/4 (25%) | 0/8 (0%) | 3/8 (37.5%) | 0/1 (0%) | ||||||||||
| Urinary tract infection | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Viral upper respiratory tract infection | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||
| Contusion | 0/4 (0%) | 3/4 (75%) | 0/4 (0%) | 3/4 (75%) | 3/4 (75%) | 3/4 (75%) | 2/4 (50%) | 6/8 (75%) | 3/8 (37.5%) | 0/1 (0%) | ||||||||||
| Excoriation | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 1/8 (12.5%) | 2/8 (25%) | 0/1 (0%) | ||||||||||
| Eye injury | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Joint dislocation | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Skin laceration | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Thermal burn | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Wound | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Investigations | ||||||||||||||||||||
| Blood pressure increased | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||||
| Decreased appetite | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||
| Arthralgia | 0/4 (0%) | 1/4 (25%) | 2/4 (50%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 1/4 (25%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Back pain | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) | 2/4 (50%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Flank pain | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Joint stiffness | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Joint swelling | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Muscle cramp | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 2/8 (25%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Muscle spasms | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Musculoskeletal stiffness | 0/4 (0%) | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Myalgia | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Neck pain | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Osteopenia | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Pain in extremity | 0/4 (0%) | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Scoliosis | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Nervous system disorders | ||||||||||||||||||||
| Cognitive disorder | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Dizziness | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) | 2/4 (50%) | 1/4 (25%) | 0/8 (0%) | 2/8 (25%) | 0/1 (0%) | ||||||||||
| Headache | 1/4 (25%) | 2/4 (50%) | 3/4 (75%) | 4/4 (100%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 2/8 (25%) | 3/8 (37.5%) | 0/1 (0%) | ||||||||||
| Hypoaesthesia | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Lethargy | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Migraine | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Paraesthesia | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Sinus headache | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Tremor | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Psychiatric disorders | ||||||||||||||||||||
| Anxiety | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Confusional state | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Depressed mood | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Depression | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Insomnia | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/8 (12.5%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Sleep disorder | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Renal and urinary disorders | ||||||||||||||||||||
| Haematuria | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Reproductive system and breast disorders | ||||||||||||||||||||
| Ejaculation disorder | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Menstruation irregular | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Premenstrual syndrome | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Vaginal haemorrhage | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Dysmenorrhoea | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Menorrhagia | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||
| Cough | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Dyspnoea | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Epistaxis | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) | 2/4 (50%) | 3/8 (37.5%) | 4/8 (50%) | 0/1 (0%) | ||||||||||
| Haemoptysis | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Pharyngolaryngeal pain | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||
| Ecchymosis | 0/4 (0%) | 0/4 (0%) | 3/4 (75%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 2/4 (50%) | 3/8 (37.5%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Erythema | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/8 (12.5%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Hyperkeratosis | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Lipohypertrophy | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Nail bed bleeding | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Pruritus | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Purpura | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 1/8 (12.5%) | 2/8 (25%) | 0/1 (0%) | ||||||||||
| Rash | 0/4 (0%) | 2/4 (50%) | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Rash erythematous | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/8 (12.5%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Rash papular | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Rash scaly | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Skin ulcer | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Vascular disorders | ||||||||||||||||||||
| Flushing | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 2/8 (25%) | 0/1 (0%) | ||||||||||
| Haematoma | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Haemorrhage | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Petechiae | 0/4 (0%) | 2/4 (50%) | 1/4 (25%) | 2/4 (50%) | 2/4 (50%) | 1/4 (25%) | 1/4 (25%) | 3/8 (37.5%) | 1/8 (12.5%) | 0/1 (0%) | ||||||||||
| Varicose vein | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
| Vascular insufficiency | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/8 (0%) | 0/8 (0%) | 0/1 (0%) | ||||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Amgen Inc. |
| Phone | 866-572-6436 |
| medinfo@amgen.com |
Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT00111475
Other Study ID Numbers:
- 20000137
First Posted:
May 23, 2005
Last Update Posted:
Jan 10, 2020
Last Verified:
Dec 1, 2019