Trial Outcomes & Findings for Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura (NCT NCT00415532)

NCT ID: NCT00415532

Last Updated: 2022-11-08

Results Overview

Occurrence of a splenectomy. Participants who discontinued study during the treatment period prior to reporting a splenectomy were considered as having had a splenectomy.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 234 participants
• Primary outcome timeframe: 52 weeks
• Results posted on: 2022-11-08

Participant Flow

First Subject Enrolled: 20-Dec-2006 Last Subject Enrolled: 01-Nov-2007

Participant milestones

Measure	Standard of Care Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.	Romiplostim Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10\^9/L for up to 52 weeks.
Treatment Period STARTED	77	157
Treatment Period Received Treatment	75	154
Treatment Period Switched to Romiplostim Group	2	0
Treatment Period COMPLETED	60	142
Treatment Period NOT COMPLETED	17	15
Safety Follow Up Period STARTED	43	30
Safety Follow Up Period COMPLETED	34	18
Safety Follow Up Period NOT COMPLETED	9	12

Reasons for withdrawal

Measure	Standard of Care Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.	Romiplostim Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10\^9/L for up to 52 weeks.
Treatment Period Adverse Event	2	3
Treatment Period Death	2	1
Treatment Period Lost to Follow-up	1	1
Treatment Period Protocol Violation	1	0
Treatment Period Withdrawal by Subject	6	6
Treatment Period Other	2	2
Treatment Period Ineligibility determined	1	1
Treatment Period Noncompliance	1	1
Treatment Period Requirement for alternative therapy	1	0
Safety Follow Up Period Adverse Event	1	3
Safety Follow Up Period Death	3	0
Safety Follow Up Period Withdrawal by Subject	2	3
Safety Follow Up Period Other	1	4
Safety Follow Up Period Ineligibility determined	1	1
Safety Follow Up Period Noncompliance	1	0
Safety Follow Up Period Requirement for alternative therapy	0	1

Baseline Characteristics

Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura

Baseline characteristics by cohort

Measure	Standard of Care n=77 Participants Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.	Romiplostim n=157 Participants Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10\^9/L for up to 52 weeks.	Total n=234 Participants Total of all reporting groups
Age, Continuous	54.7 Years STANDARD_DEVIATION 19.3 • n=5 Participants	54.8 Years STANDARD_DEVIATION 18.8 • n=7 Participants	54.7 Years STANDARD_DEVIATION 18.9 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	85 Participants n=7 Participants	131 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	72 Participants n=7 Participants	103 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	69 Participants n=5 Participants	137 Participants n=7 Participants	206 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Asian (Chinese, Bangladeshi, Indian, Pakistani)	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: The Full Analysis set includes all randomized patients.

Occurrence of a splenectomy. Participants who discontinued study during the treatment period prior to reporting a splenectomy were considered as having had a splenectomy.

Outcome measures

Measure	Standard of Care n=77 Participants Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.	Romiplostim n=157 Participants Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10\^9/L for up to 52 weeks.
Number of Participants With Splenectomy During 52-Week Treatment Period Had splenectomy	28 Participants	14 Participants
Number of Participants With Splenectomy During 52-Week Treatment Period Did not have splenectomy	49 Participants	143 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: Full analysis set. Participants who discontinued study during treatment period prior to experiencing treatment failure were considered as having had treatment failure.

Treatment failure was defined by platelet counts ≤ 20 x 10^9/L for 4 consecutive weeks at the highest recommended dose and schedule, a major bleeding event, or change in therapy due to an intolerable side effect or bleeding symptom.

Outcome measures

Measure	Standard of Care n=77 Participants Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.	Romiplostim n=157 Participants Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10\^9/L for up to 52 weeks.
Number of Participants With Treatment Failure During 52-Week Treatment Period Had treatment failure	23 Participants	18 Participants
Number of Participants With Treatment Failure During 52-Week Treatment Period Did not have treatment failure	54 Participants	139 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Full analysis set

Time to splenectomy in days calculated from date of randomization to date of splenectomy, or censored at date of end of treatment visit if no splenectomy was done during treatment period.

Outcome measures

Measure	Standard of Care n=77 Participants Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.	Romiplostim n=157 Participants Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10\^9/L for up to 52 weeks.
Time to Splenectomy	NA days Median and 95% confidence interval could not be estimated due to the low number of patients with splenectomy (15).	NA days Median and 95% confidence interval could not be estimated due to the low number of patients with splenectomy (2).

SECONDARY outcome

Timeframe: Weeks 1-8, and Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Population: Full analysis set. "N" indicates the number of participants with available data at each time point.

Platelet response was defined as platelet counts > 50 x 10^9/L, measured at each study visit (excluding those within 8 weeks of prior rescue medication use) up to the time of splenectomy or the end of initial treatment period, whichever occurred first.

Outcome measures

Measure	Standard of Care n=77 Participants Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.	Romiplostim n=157 Participants Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10\^9/L for up to 52 weeks.
Percentage of Participants With Platelet Response Week 52 [N=38, 122]	50.0 percentage of participants	90.2 percentage of participants
Percentage of Participants With Platelet Response Week 1 [N=75, 154]	6.7 percentage of participants	3.9 percentage of participants
Percentage of Participants With Platelet Response Week 2 [N=71, 153]	28.2 percentage of participants	75.8 percentage of participants
Percentage of Participants With Platelet Response Week 3 [N=70, 152]	34.3 percentage of participants	73.0 percentage of participants
Percentage of Participants With Platelet Response Week 4 [N=170, 152]	30.0 percentage of participants	73.7 percentage of participants
Percentage of Participants With Platelet Response Week 5 [N=68, 152]	32.4 percentage of participants	71.1 percentage of participants
Percentage of Participants With Platelet Response Week 6 [N=66, 151]	30.3 percentage of participants	74.2 percentage of participants
Percentage of Participants With Platelet Response Week 7 [N=66, 151]	30.3 percentage of participants	75.5 percentage of participants
Percentage of Participants With Platelet Response Week 8 [N=65, 151]	29.2 percentage of participants	68.2 percentage of participants
Percentage of Participants With Platelet Response Week 12 [N=62, 149]	25.8 percentage of participants	79.2 percentage of participants
Percentage of Participants With Platelet Response Week 16 [N=61, 147]	34.4 percentage of participants	82.3 percentage of participants
Percentage of Participants With Platelet Response Week 20 [N=58, 139]	36.2 percentage of participants	83.5 percentage of participants
Percentage of Participants With Platelet Response Week 24 [N=58, 138]	31.0 percentage of participants	92.0 percentage of participants
Percentage of Participants With Platelet Response Week 28 [N=57, 137]	40.4 percentage of participants	88.3 percentage of participants
Percentage of Participants With Platelet Response Week 32 [N=55, 135]	34.5 percentage of participants	87.4 percentage of participants
Percentage of Participants With Platelet Response Week 36 [N=54, 135]	33.3 percentage of participants	89.6 percentage of participants
Percentage of Participants With Platelet Response Week 40 [N=52, 134]	38.5 percentage of participants	88.8 percentage of participants
Percentage of Participants With Platelet Response Week 44 [N=51, 131]	51.0 percentage of participants	86.3 percentage of participants
Percentage of Participants With Platelet Response Week 48 [N=48, 130]	41.7 percentage of participants	88.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline and 52 weeks

Population: Full analysis set

Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of symptoms. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life.

Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates.

Outcome measures

Measure	Standard of Care n=77 Participants Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.	Romiplostim n=157 Participants Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10\^9/L for up to 52 weeks.
Change in ITP-PAQ Physical Health Domain of Symptoms	12.5 Units on a scale Standard Error 2.1	16.0 Units on a scale Standard Error 1.9

SECONDARY outcome

Timeframe: Baseline and 52 weeks

Population: Full analysis set.

Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of fatigue. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life. Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates.

Outcome measures

Measure	Standard of Care n=77 Participants Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.	Romiplostim n=157 Participants Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10\^9/L for up to 52 weeks.
Change in ITP-PAQ Physical Health Domain of Fatigue	9.5 Units on a scale Standard Error 3.2	11.2 Units on a scale Standard Error 3.1

SECONDARY outcome

Timeframe: Baseline and 52 weeks

Population: Full analysis set

Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of bother. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life. Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates.

Outcome measures

Measure	Standard of Care n=77 Participants Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.	Romiplostim n=157 Participants Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10\^9/L for up to 52 weeks.
Change in ITP-PAQ Physical Health Domain of Bother	13.0 Units on a scale Standard Error 2.7	16.8 Units on a scale Standard Error 2.5

SECONDARY outcome

Timeframe: Baseline and 52 weeks

Population: Full analysis set

Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of activity. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life.

Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates.

Outcome measures

Measure	Standard of Care n=77 Participants Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.	Romiplostim n=157 Participants Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10\^9/L for up to 52 weeks.
Change in ITP-PAQ Physical Health Domain of Activity	8.2 Units on a scale Standard Error 3.7	17.1 Units on a scale Standard Error 3.5

Adverse Events

Standard of Care

Serious events: 28 serious events

Other events: 60 other events

Deaths: 0 deaths

AMG 531

Serious events: 36 serious events

Other events: 136 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard of Care n=73 participants at risk Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.	AMG 531 n=156 participants at risk
Blood and lymphatic system disorders Coagulopathy	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Blood and lymphatic system disorders Haemorrhagic diathesis	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Blood and lymphatic system disorders Idiopathic thrombocytopenic purpura	4.1% 3/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Blood and lymphatic system disorders Thrombocytopenia	11.0% 8/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	3.8% 6/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Cardiac disorders Arrhythmia	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Cardiac disorders Atrial fibrillation	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Cardiac disorders Cardiac failure congestive	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Cardiac disorders Cardio-respiratory arrest	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Cardiac disorders Left ventricular failure	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Cardiac disorders Myocardial infarction	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Cardiac disorders Palpitations	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Cardiac disorders Ventricular fibrillation	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Eye disorders Ocular vascular disorder	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Gastrointestinal disorders Abdominal pain	2.7% 2/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Gastrointestinal disorders Abdominal pain upper	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Gastrointestinal disorders Dental caries	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Gastrointestinal disorders Haematemesis	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Gastrointestinal disorders Nausea	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Gastrointestinal disorders Pancreatic fistula	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Gastrointestinal disorders Pancreatitis	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Gastrointestinal disorders Vomiting	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
General disorders Asthenia	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
General disorders Face oedema	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
General disorders Oedema peripheral	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	1.9% 3/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
General disorders Pyrexia	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Hepatobiliary disorders Cholecystitis	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Hepatobiliary disorders Hepatic failure	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Hepatobiliary disorders Hepatitis toxic	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Immune system disorders Hypersensitivity	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Appendicitis	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Bacteraemia	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Bronchitis	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Cellulitis	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Gastroenteritis norovirus	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Herpes zoster	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Klebsiella infection	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Lobar pneumonia	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Lower respiratory tract infection	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Pneumonia	2.7% 2/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	2.6% 4/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Sepsis	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Subdiaphragmatic abscess	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Tooth abscess	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Urinary tract infection	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Injury, poisoning and procedural complications Contusion	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	1.3% 2/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Injury, poisoning and procedural complications Rib fracture	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Injury, poisoning and procedural complications Spinal compression fracture	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Investigations Liver function test abnormal	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Investigations Platelet count decreased	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Metabolism and nutrition disorders Malnutrition	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	1.3% 2/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	1.3% 2/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Musculoskeletal and connective tissue disorders Flank pain	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Musculoskeletal and connective tissue disorders Osteonecrosis	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	1.3% 2/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Musculoskeletal and connective tissue disorders Pain in extremity	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	1.3% 2/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Musculoskeletal and connective tissue disorders Polyarthritis	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm skin	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Nervous system disorders Depressed level of consciousness	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Nervous system disorders Dizziness	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Nervous system disorders Headache	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Nervous system disorders Hepatic encephalopathy	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Nervous system disorders Lethargy	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Nervous system disorders Spinal haematoma	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Nervous system disorders Syncope	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Psychiatric disorders Psychosomatic disease	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Renal and urinary disorders Renal colic	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Renal and urinary disorders Renal failure	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Renal and urinary disorders Renal failure acute	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Renal and urinary disorders Renal impairment	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	1.3% 2/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Respiratory, thoracic and mediastinal disorders Lung infiltration	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	1.9% 3/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Skin and subcutaneous tissue disorders Dermatitis allergic	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Skin and subcutaneous tissue disorders Rash	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	1.3% 2/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Vascular disorders Circulatory collapse	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Vascular disorders Deep vein thrombosis	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	1.3% 2/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Vascular disorders Haemorrhage	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Vascular disorders Hypertensive crisis	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.00% 0/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Vascular disorders Hypotension	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.

Other adverse events

Measure	Standard of Care n=73 participants at risk Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.	AMG 531 n=156 participants at risk
Blood and lymphatic system disorders Anaemia	5.5% 4/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	3.8% 6/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Ear and labyrinth disorders Vertigo	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	5.8% 9/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Gastrointestinal disorders Abdominal pain	2.7% 2/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	5.1% 8/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Gastrointestinal disorders Abdominal pain upper	8.2% 6/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	2.6% 4/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Gastrointestinal disorders Constipation	8.2% 6/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	10.3% 16/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Gastrointestinal disorders Diarrhoea	5.5% 4/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	13.5% 21/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Gastrointestinal disorders Dyspepsia	5.5% 4/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	1.3% 2/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Gastrointestinal disorders Gingival bleeding	6.8% 5/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	5.8% 9/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Gastrointestinal disorders Nausea	8.2% 6/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	15.4% 24/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Gastrointestinal disorders Vomiting	2.7% 2/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	7.1% 11/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
General disorders Chest pain	5.5% 4/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	3.8% 6/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
General disorders Fatigue	21.9% 16/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	27.6% 43/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
General disorders Influenza like illness	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	5.1% 8/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
General disorders Oedema peripheral	4.1% 3/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	9.6% 15/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
General disorders Pain	2.7% 2/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	7.1% 11/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
General disorders Pyrexia	11.0% 8/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	9.6% 15/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Immune system disorders Hypersensitivity	5.5% 4/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	1.9% 3/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Bronchitis	2.7% 2/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	5.8% 9/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Gastroenteritis	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	6.4% 10/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Influenza	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	8.3% 13/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Nasopharyngitis	19.2% 14/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	23.1% 36/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Sinusitis	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	8.3% 13/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Upper respiratory tract infection	8.2% 6/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	11.5% 18/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Infections and infestations Urinary tract infection	9.6% 7/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	11.5% 18/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Injury, poisoning and procedural complications Contusion	17.8% 13/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	14.1% 22/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Injury, poisoning and procedural complications Procedural pain	6.8% 5/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	1.3% 2/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Metabolism and nutrition disorders Hypokalaemia	8.2% 6/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	1.3% 2/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Musculoskeletal and connective tissue disorders Arthralgia	5.5% 4/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	14.7% 23/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Musculoskeletal and connective tissue disorders Back pain	5.5% 4/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	10.3% 16/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Musculoskeletal and connective tissue disorders Muscle spasms	5.5% 4/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	7.1% 11/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.1% 3/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	9.0% 14/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Musculoskeletal and connective tissue disorders Myalgia	1.4% 1/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	10.9% 17/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Musculoskeletal and connective tissue disorders Neck pain	5.5% 4/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	0.64% 1/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Musculoskeletal and connective tissue disorders Pain in extremity	8.2% 6/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	12.8% 20/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Nervous system disorders Dizziness	8.2% 6/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	13.5% 21/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Nervous system disorders Headache	19.2% 14/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	34.6% 54/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Nervous system disorders Paraesthesia	0.00% 0/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	5.8% 9/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Psychiatric disorders Insomnia	12.3% 9/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	9.0% 14/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Respiratory, thoracic and mediastinal disorders Cough	5.5% 4/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	16.0% 25/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.5% 4/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	9.6% 15/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Respiratory, thoracic and mediastinal disorders Epistaxis	23.3% 17/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	18.6% 29/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.5% 4/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	12.2% 19/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Skin and subcutaneous tissue disorders Ecchymosis	5.5% 4/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	6.4% 10/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Skin and subcutaneous tissue disorders Petechiae	17.8% 13/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	16.0% 25/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Skin and subcutaneous tissue disorders Pruritus	6.8% 5/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	10.3% 16/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Skin and subcutaneous tissue disorders Rash	6.8% 5/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	8.3% 13/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Vascular disorders Haematoma	12.3% 9/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	7.7% 12/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.
Vascular disorders Hypertension	5.5% 4/73 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.	2.6% 4/156 • 52 week treatment period The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. 2 patients in Standard of Care (SOC) and 3 patients in the romiplostim arm did not receive the randomized treatment. 2 patients who were randomized to SOC and switched to romiplostim arm were counted in the Romiplostim arm.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER