Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)

• Sponsor: Amgen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00117143
• Collaborator: (none)
• Enrollment: 16
• Arm: 1
• Actual Duration (Months): 19.5

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and tolerability of AMG 531 (romiplostim), a novel thrombopoiesis-stimulating peptibody, and its effect on platelet counts in adults with immune thrombocytopenic purpura.

Condition or Disease	Intervention/Treatment	Phase
Thrombocytopenic Purpura	Drug: Romiplostim	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Unit Dose-finding Study Evaluating the Safety and Efficacy of Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
• Actual Study Start Date: Dec 2, 2002
• Actual Primary Completion Date: Jul 19, 2004
• Actual Study Completion Date: Jul 19, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Romiplostim Participants will receive a maximum of 2 administrations of romiplostim by subcutaneous injection, the first on day 1 of the study and the second on day 15 or 22 depending on the participant's platelet count. Romiplostim doses to be tested were 30, 100, 300, and 500 μg.	Drug: Romiplostim; Administered subcutaneously on day 1 and on day 15 or 22 if the platelet count was ≤ 50 x 10⁹/L and not rising, peak platelet count was ≤ 450 x 10⁹/L and no serious adverse events related to treatment were observed.; Other Names: AMG 531 NPLATE

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events [From first dose through 8 weeks after last dose of study drug (11 weeks)]

2. Number of Participants With Positive Anti-Romiplostim Antibodies [Days 29 and 78]

   The presence or development of antibodies to romiplostim and endogenous thrombopoietin was assessed using a neutralizing bioassay. Antibody analyses were conducted on study days 29 and at the end-of-study visit (day 78). The number of participants with positive antibody binding at any time during the study is reported.

Secondary Outcome Measures

1. Number of Participants Who Achieved a Targeted Therapeutic Platelet Response [Baseline and after first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 in all participants)]

   Targeted therapeutic platelet response was defined as a (single) platelet count that was double the baseline level and between 50 and 450 × 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.

2. Number of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L From Baseline [Baseline and after first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 in all participants)]

   Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.

3. Number of Participants With Peak Platelet Counts of ≥ 100 x 10⁹ Cells/L [After first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22), and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 for all participants)]

   Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.

4. Number of Participants With Peak Platelet Counts of ≥ 450 x 10⁹ Cells/L [After first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22), and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 for all participants)]

   Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.

5. Change From Baseline to Peak Platelet Level [Baseline and after first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 in all participants)]

   Platelet count data after the use of rescue medication were not included.

6. Time to Peak Platelet Count [From first dose of study drug to day 15 or 22, and from the second dose of study drug (day 15 or 22) to day 78]

   Time from the date of study drug administration (day 1, 15 or 22) to the day of peak platelet count after each dose. Platelet count data after the use of rescue medication were not included.

7. Duration Within the Targeted Therapeutic Range [From first dose of study drug to day 15 or 22, and from the second dose of study drug (day 15 or 22) to day 78]

   Targeted therapeutic platelet level was defined as a platelet count that was double the baseline level and between 50 and 450 × 10⁹ cells/L. Platelet count data after the use of rescue medication were not included.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Greater than or equal to 3 months history of ITP, regardless of splenectomy status, and completion of at least 1 prior treatment for ITP

• 2 of 3 pretreatment platelet counts that were less than 30 x 10^{9/L (if not currently on ITP therapy) or less than 50 x 10}9/L (if currently receiving corticosteroids for ITP therapy)

• Ability to give informed consent

Exclusion Criteria:

• Known history of arterial thrombosis, active malignancy, or bone marrow stem cell disorder

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
• FDA-approved Drug Labeling

Publications

• 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.
• Newland A, Caulier MT, Kappers-Klunne M, Schipperus MR, Lefrere F, Zwaginga JJ, Christal J, Chen CF, Nichol JL. An open-label, unit dose-finding study of AMG 531, a novel thrombopoiesis-stimulating peptibody, in patients with immune thrombocytopenic purpura. Br J Haematol. 2006 Nov;135(4):547-53.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT00117143
• Other Study ID Numbers: 20010218
• First Posted: Jul 4, 2005
• Last Update Posted: Dec 20, 2019
• Last Verified: Nov 1, 2019

• Keywords provided by Amgen: Immune Thrombocytopenic Purpura; Idiopathic Thrombocytopenic Purpura; ITP; Thrombocytopenia
• Additional relevant MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic

Study Results

Participant Flow

Recruitment Details	This was a multicenter study conducted in 6 centers in France, the Netherlands, and the United Kingdom.
Pre-assignment Detail	Participants were enrolled sequentially into one of four dose cohorts. When the platelet count of the first participant who received the 500 μg dose increased above 650 × 10⁹ cells/L following the first dose, this cohort was discontinued, and subsequent participants were assigned to the 300 μg cohort.

Arm/Group Title	Romiplostim 30 µg	Romiplostim 100 µg	Romiplostim 300 µg	Romiplostim 500 µg
Arm/Group Description	Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Period Title: Overall Study
STARTED	4	4	7	1
Received First Dose	4	4	7	1
Received Second Dose	4	4	6	0
COMPLETED	4	4	7	1
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Romiplostim 30 µg	Romiplostim 100 µg	Romiplostim 300 µg	Romiplostim 500 µg	Total
Arm/Group Description	Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Total of all reporting groups
Overall Participants	4	4	7	1	16
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.3 (14.9)	37.8 (13.4)	53.9 (20.4)	45.0	50.9 (17.9)
Sex: Female, Male (Count of Participants)
Female	3 75%	2 50%	4 57.1%	1 100%	10 62.5%
Male	1 25%	2 50%	3 42.9%	0 0%	6 37.5%
Race/Ethnicity, Customized (Count of Participants)
White	4 100%	4 100%	6 85.7%	1 100%	15 93.8%
Black	0 0%	0 0%	1 14.3%	0 0%	1 6.3%
Platelet Count (10⁹cells/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [10⁹cells/L]	13.0 (6.10)	16.5 (10.4)	16.4 (7.77)	28.8	16.3 (8.15)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events
Time Frame	From first dose through 8 weeks after last dose of study drug (11 weeks)

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of romiplostim

Arm/Group Title	Romiplostim 30 µg	Romiplostim 100 µg	Romiplostim 300 µg	Romiplostim 500 µg
Arm/Group Description	Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Measure Participants	4	4	7	1
All adverse events	4 100%	4 100%	7 100%	1 100%
Serious adverse events	0 0%	0 0%	3 42.9%	1 100%
Treatment-related adverse events	1 25%	3 75%	3 42.9%	1 100%
Serious treatment-related adverse events	0 0%	0 0%	1 14.3%	1 100%
Discontinuations due to adverse events	0 0%	0 0%	0 0%	0 0%
Deaths	0 0%	0 0%	0 0%	0 0%

2. Primary Outcome

Title	Number of Participants With Positive Anti-Romiplostim Antibodies
Description	The presence or development of antibodies to romiplostim and endogenous thrombopoietin was assessed using a neutralizing bioassay. Antibody analyses were conducted on study days 29 and at the end-of-study visit (day 78). The number of participants with positive antibody binding at any time during the study is reported.
Time Frame	Days 29 and 78

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of romiplostim

Arm/Group Title	Romiplostim 30 µg	Romiplostim 100 µg	Romiplostim 300 µg	Romiplostim 500 µg
Arm/Group Description	Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Measure Participants	4	4	7	1
Anti-romiplostim antibodies	0 0%	0 0%	0 0%	0 0%
Anti-thrombopoietin antibodies	0 0%	0 0%	0 0%	0 0%

3. Secondary Outcome

Title	Number of Participants Who Achieved a Targeted Therapeutic Platelet Response
Description	Targeted therapeutic platelet response was defined as a (single) platelet count that was double the baseline level and between 50 and 450 × 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	Baseline and after first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 in all participants)

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of romiplostim.

Arm/Group Title	Romiplostim 30 µg	Romiplostim 100 µg	Romiplostim 300 µg	Romiplostim 500 µg
Arm/Group Description	Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Measure Participants	4	4	7	1
After First Dose	1 25%	4 100%	4 57.1%	0 0%
After Second Dose	1 25%	3 75%	3 42.9%
After Both Doses	1 25%	3 75%	3 42.9%

4. Secondary Outcome

Title	Number of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L From Baseline
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	Baseline and after first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 in all participants)

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of romiplostim.

Arm/Group Title	Romiplostim 30 µg	Romiplostim 100 µg	Romiplostim 300 µg	Romiplostim 500 µg
Arm/Group Description	Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Measure Participants	4	4	7	1
After First Dose	2 50%	4 100%	5 71.4%	1 100%
After Second Dose	1 25%	3 75%	4 57.1%
After Both Doses	1 25%	3 75%	3 42.9%

5. Secondary Outcome

Title	Number of Participants With Peak Platelet Counts of ≥ 100 x 10⁹ Cells/L
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 (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22), and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 for all participants)

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of romiplostim.

Arm/Group Title	Romiplostim 30 µg	Romiplostim 100 µg	Romiplostim 300 µg	Romiplostim 500 µg
Arm/Group Description	Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Measure Participants	4	4	7	1
After First Dose	1 25%	3 75%	3 42.9%	1 100%
After Second Dose	0 0%	1 25%	2 28.6%
After Both Doses	0 0%	1 25%	1 14.3%

6. Secondary Outcome

Title	Number of Participants With Peak Platelet Counts of ≥ 450 x 10⁹ Cells/L
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 (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22), and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 for all participants)

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of romiplostim.

Arm/Group Title	Romiplostim 30 µg	Romiplostim 100 µg	Romiplostim 300 µg	Romiplostim 500 µg
Arm/Group Description	Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Measure Participants	4	4	7	1
After First Dose	0 0%	0 0%	1 14.3%	1 100%
After Second Dose	0 0%	0 0%	0 0%
After Both Doses	0 0%	0 0%	0 0%

7. Secondary Outcome

Title	Change From Baseline to Peak Platelet Level
Description	Platelet count data after the use of rescue medication were not included.
Time Frame	Baseline and after first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 in all participants)

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of romiplostim with available data.

Arm/Group Title	Romiplostim 30 µg	Romiplostim 100 µg	Romiplostim 300 µg	Romiplostim 500 µg
Arm/Group Description	Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Measure Participants	4	4	7	1
After First Dose	38.75 (50.50)	89.98 (34.44)	271.3 (558.4)	1033.20 (NA)
After Second Dose	11.50 (14.51)	46.48 (25.15)	56.38 (35.00)

8. Secondary Outcome

Title	Time to Peak Platelet Count
Description	Time from the date of study drug administration (day 1, 15 or 22) to the day of peak platelet count after each dose. Platelet count data after the use of rescue medication were not included.
Time Frame	From first dose of study drug to day 15 or 22, and from the second dose of study drug (day 15 or 22) to day 78

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of romiplostim with available data.

Arm/Group Title	Romiplostim 30 µg	Romiplostim 100 µg	Romiplostim 300 µg	Romiplostim 500 µg
Arm/Group Description	Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Measure Participants	4	4	7	1
After First Dose	10.5	9.0	12.0	17.0
After Second Dose	13.5	9.5	9.0

9. Secondary Outcome

Title	Duration Within the Targeted Therapeutic Range
Description	Targeted therapeutic platelet level was defined as a platelet count that was double the baseline level and between 50 and 450 × 10⁹ cells/L. Platelet count data after the use of rescue medication were not included.
Time Frame	From first dose of study drug to day 15 or 22, and from the second dose of study drug (day 15 or 22) to day 78

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of romiplostim with a targeted therapeutic response.

Arm/Group Title	Romiplostim 30 µg	Romiplostim 100 µg	Romiplostim 300 µg	Romiplostim 500 µg
Arm/Group Description	Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.	Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
Measure Participants	1	4	4	0
After First Dose	10.0	5.5	8.0
After Second Dose	1.0	2.0	8.0

Adverse Events

Time Frame	From first dose through 8 weeks after last dose of study drug (11 weeks).
Adverse Event Reporting Description	Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Arm/Group Title	Romiplostim 30 µg		Romiplostim 100 µg		Romiplostim 300 µg		Romiplostim 500 µg
Arm/Group Description	Participants received 30 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.		Participants received 100 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.		Participants received 300 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.		Participants received 500 µg romiplostim by subcutaneous injection on day 1 and a possible second dose on day 15 or 22 depending on the participant's platelet count.
All Cause Mortality
	Romiplostim 30 µg		Romiplostim 100 µg		Romiplostim 300 µg		Romiplostim 500 µg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Romiplostim 30 µg		Romiplostim 100 µg		Romiplostim 300 µg		Romiplostim 500 µg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)		3/7 (42.9%)		1/1 (100%)
Blood and lymphatic system disorders
Anaemia	0/4 (0%)		0/4 (0%)		1/7 (14.3%)		0/1 (0%)
Thrombocytopenia	0/4 (0%)		0/4 (0%)		1/7 (14.3%)		0/1 (0%)
Gastrointestinal disorders
Rectal haemorrhage	0/4 (0%)		0/4 (0%)		1/7 (14.3%)		0/1 (0%)
Infections and infestations
Lower respiratory tract infection	0/4 (0%)		0/4 (0%)		1/7 (14.3%)		0/1 (0%)
Investigations
Blood lactate dehydrogenase increased	0/4 (0%)		0/4 (0%)		0/7 (0%)		1/1 (100%)
Nervous system disorders
Headache	0/4 (0%)		0/4 (0%)		0/7 (0%)		1/1 (100%)
Other (Not Including Serious) Adverse Events
	Romiplostim 30 µg		Romiplostim 100 µg		Romiplostim 300 µg		Romiplostim 500 µg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/4 (100%)		4/4 (100%)		7/7 (100%)		1/1 (100%)
Blood and lymphatic system disorders
Thrombocythaemia	0/4 (0%)		0/4 (0%)		1/7 (14.3%)		0/1 (0%)
Cardiac disorders
Palpitations	0/4 (0%)		1/4 (25%)		0/7 (0%)		0/1 (0%)
Ear and labyrinth disorders
Tinnitus	0/4 (0%)		0/4 (0%)		1/7 (14.3%)		0/1 (0%)
Vertigo	1/4 (25%)		0/4 (0%)		0/7 (0%)		0/1 (0%)
Eye disorders
Conjunctival haemorrhage	0/4 (0%)		1/4 (25%)		0/7 (0%)		0/1 (0%)
Gastrointestinal disorders
Aphthous stomatitis	0/4 (0%)		1/4 (25%)		0/7 (0%)		0/1 (0%)
Diarrhoea	1/4 (25%)		0/4 (0%)		1/7 (14.3%)		0/1 (0%)
Gingival bleeding	0/4 (0%)		1/4 (25%)		0/7 (0%)		0/1 (0%)
Mouth haemorrhage	0/4 (0%)		0/4 (0%)		2/7 (28.6%)		0/1 (0%)
Nausea	0/4 (0%)		1/4 (25%)		0/7 (0%)		0/1 (0%)
Oral mucosal petechiae	0/4 (0%)		1/4 (25%)		1/7 (14.3%)		0/1 (0%)
Rectal haemorrhage	0/4 (0%)		0/4 (0%)		1/7 (14.3%)		0/1 (0%)
General disorders
Asthenia	1/4 (25%)		0/4 (0%)		0/7 (0%)		0/1 (0%)
Chest pain	0/4 (0%)		0/4 (0%)		1/7 (14.3%)		0/1 (0%)
Fatigue	0/4 (0%)		1/4 (25%)		3/7 (42.9%)		0/1 (0%)
Injection site haemorrhage	1/4 (25%)		1/4 (25%)		1/7 (14.3%)		0/1 (0%)
Injection site pain	1/4 (25%)		0/4 (0%)		0/7 (0%)		0/1 (0%)
Malaise	0/4 (0%)		0/4 (0%)		1/7 (14.3%)		0/1 (0%)
Oedema peripheral	0/4 (0%)		0/4 (0%)		3/7 (42.9%)		0/1 (0%)
Infections and infestations
Ear infection	0/4 (0%)		0/4 (0%)		1/7 (14.3%)		0/1 (0%)
Gastrointestinal infection	0/4 (0%)		1/4 (25%)		0/7 (0%)		0/1 (0%)
Influenza	1/4 (25%)		0/4 (0%)		0/7 (0%)		0/1 (0%)
Nasopharyngitis	0/4 (0%)		1/4 (25%)		2/7 (28.6%)		0/1 (0%)
Injury, poisoning and procedural complications
Contusion	0/4 (0%)		2/4 (50%)		2/7 (28.6%)		0/1 (0%)
Head injury	0/4 (0%)		1/4 (25%)		0/7 (0%)		0/1 (0%)
Limb injury	0/4 (0%)		0/4 (0%)		1/7 (14.3%)		0/1 (0%)
Muscle strain	0/4 (0%)		0/4 (0%)		1/7 (14.3%)		0/1 (0%)
Metabolism and nutrition disorders
Anorexia	1/4 (25%)		0/4 (0%)		0/7 (0%)		0/1 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/4 (0%)		2/4 (50%)		3/7 (42.9%)		0/1 (0%)
Back pain	1/4 (25%)		0/4 (0%)		0/7 (0%)		1/1 (100%)
Pain in extremity	0/4 (0%)		0/4 (0%)		2/7 (28.6%)		0/1 (0%)
Nervous system disorders
Headache	0/4 (0%)		3/4 (75%)		4/7 (57.1%)		1/1 (100%)
Lethargy	0/4 (0%)		1/4 (25%)		0/7 (0%)		0/1 (0%)
Reproductive system and breast disorders
Breast mass	0/4 (0%)		0/4 (0%)		1/7 (14.3%)		0/1 (0%)
Menorrhagia	0/4 (0%)		1/4 (25%)		0/7 (0%)		0/1 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/4 (0%)		1/4 (25%)		0/7 (0%)		0/1 (0%)
Epistaxis	1/4 (25%)		1/4 (25%)		2/7 (28.6%)		0/1 (0%)
Increased viscosity of bronchial secretion	1/4 (25%)		0/4 (0%)		0/7 (0%)		0/1 (0%)
Pharyngolaryngeal pain	0/4 (0%)		1/4 (25%)		0/7 (0%)		0/1 (0%)
Sinus congestion	0/4 (0%)		0/4 (0%)		1/7 (14.3%)		0/1 (0%)
Skin and subcutaneous tissue disorders
Ecchymosis	1/4 (25%)		1/4 (25%)		1/7 (14.3%)		0/1 (0%)
Hyperhidrosis	0/4 (0%)		1/4 (25%)		0/7 (0%)		0/1 (0%)
Purpura	0/4 (0%)		0/4 (0%)		1/7 (14.3%)		0/1 (0%)
Rash	0/4 (0%)		1/4 (25%)		0/7 (0%)		0/1 (0%)
Skin bleeding	0/4 (0%)		0/4 (0%)		1/7 (14.3%)		0/1 (0%)
Skin lesion	0/4 (0%)		0/4 (0%)		1/7 (14.3%)		0/1 (0%)
Vascular disorders
Haematoma	0/4 (0%)		0/4 (0%)		1/7 (14.3%)		1/1 (100%)
Petechiae	0/4 (0%)		2/4 (50%)		1/7 (14.3%)		1/1 (100%)

Limitations/Caveats

[Not Specified]

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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.