Trial Outcomes & Findings for A Safety and Efficacy Study to Evaluate AMG 531 Treatment in Subject With Myelodysplastic Syndrome Receiving Revlimid (NCT NCT00418665)

Last Updated: 2011-01-24

Results Overview

Occurrence of one or more clinically significant thrombocytopenic events, defined as either Common Terminology Criteria for Adverse Events (CTCAE) v. 3 grade 3 or 4 thrombocytopenia starting from week 3 of cycle 1 or receipt of platelet transfusions starting from week 1 of cycle 1 and continuing through the end of treatment visit.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Treatment period through interim follow-up visit (up to 16 weeks)

Results posted on

2011-01-24

Participant Flow

Participants were enrolled from 14 March 2007 through 24 July 2008

Participant milestones

Participant milestones
Measure	Placebo Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks	Romiplostim (AMG 531) 500 μg Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks	Romiplostim (AMG 531) 750 μg Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
Treatment Period STARTED	12	14	13
Treatment Period Received Study Medication	11	13	13
Treatment Period COMPLETED	7	8	9
Treatment Period NOT COMPLETED	5	6	4
Treatment Extension STARTED	7	8	9
Treatment Extension COMPLETED	1	4	7
Treatment Extension NOT COMPLETED	6	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks	Romiplostim (AMG 531) 500 μg Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks	Romiplostim (AMG 531) 750 μg Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
Treatment Period Ineligibility determined	1	1	0
Treatment Period Adverse Event	2	2	0
Treatment Period Withdrawal by Subject	0	3	1
Treatment Period Requirement for alternative therapy	1	0	0
Treatment Period Physician Decision	1	0	3
Treatment Extension Adverse Event	1	0	0
Treatment Extension Withdrawal by Subject	1	0	0
Treatment Extension Requirement for alternative therapy	2	2	0
Treatment Extension Physician Decision	2	2	1
Treatment Extension Death	0	0	1

Baseline Characteristics

A Safety and Efficacy Study to Evaluate AMG 531 Treatment in Subject With Myelodysplastic Syndrome Receiving Revlimid

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=12 Participants Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks	Romiplostim 500 μg n=14 Participants Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks	Romiplostim 750 μg n=13 Participants Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks	Total n=39 Participants Total of all reporting groups
Age Continuous	73.2 Years STANDARD_DEVIATION 15.0 • n=93 Participants	72.9 Years STANDARD_DEVIATION 11.4 • n=4 Participants	66.7 Years STANDARD_DEVIATION 9.4 • n=27 Participants	70.9 Years STANDARD_DEVIATION 12.1 • n=483 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	6 Participants n=4 Participants	5 Participants n=27 Participants	15 Participants n=483 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	8 Participants n=4 Participants	8 Participants n=27 Participants	24 Participants n=483 Participants
Race/Ethnicity, Customized White or Caucasian	11 Participants n=93 Participants	13 Participants n=4 Participants	12 Participants n=27 Participants	36 Participants n=483 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants
International Prognostic Scoring System (IPSS) Score 0	4 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants	14 Participants n=483 Participants
International Prognostic Scoring System (IPSS) Score 0.5	3 Participants n=93 Participants	6 Participants n=4 Participants	4 Participants n=27 Participants	13 Participants n=483 Participants
International Prognostic Scoring System (IPSS) Score 1.0	3 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants	8 Participants n=483 Participants
International Prognostic Scoring System (IPSS) Score >1.0	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants
International Prognostic Scoring System (IPSS) Score Missing	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants

PRIMARY outcome

Timeframe: Treatment period through interim follow-up visit (up to 16 weeks)

Population: Full Analysis Set, composed of all randomized participants

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks	Romiplostim 500 μg n=14 Participants Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks	Romiplostim 750 μg n=13 Participants Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
Occurrence of a Clinically Significant Thrombocytopenic Event	8 Participants	4 Participants	8 Participants

SECONDARY outcome

Timeframe: Treatment period (up to 16 weeks)

Population: Full Analysis Set, composed of all randomized participants

Occurrence of lenalidomide dose reduction and delay due to thrombocytopenia

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks	Romiplostim 500 μg n=14 Participants Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks	Romiplostim 750 μg n=13 Participants Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia	6 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Treatment period and post-treatment follow-up (up to 21 weeks)

Population: Full Analysis Set, composed of all randomized participants

CR = decrease in bone marrow blast (≤5%) and improvement in peripheral blood counts (Hgb ≥ 11 g/dL, platelets ≥ 100x10\^9/L, neutrophils ≥ 1x10\^9/L, peripheral blasts=0%). PR = improvement in peripheral blood counts plus a decrease in bone marrow blasts ≥50% but not ≤5, or decrease in International Prognostic Scoring System score.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks	Romiplostim 500 μg n=14 Participants Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks	Romiplostim 750 μg n=13 Participants Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
Achieving an Overall Response (Complete Response (CR) or Partial Response (PR)) Determined by the Investigator Based on Modified International Working Group 2006 Response Criteria Guidelines	1 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Treatment period (up to 16 weeks)

Population: Full Analysis Set, composed of all randomized participants

Occurrence of one or more platelet transfusions during the treatment period

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks	Romiplostim 500 μg n=14 Participants Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks	Romiplostim 750 μg n=13 Participants Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
Platelet Transfusion	4 Participants	4 Participants	4 Participants

Adverse Events

Placebo

Serious events: 6 serious events

Other events: 8 other events

Deaths: 0 deaths

Romiplostim 500 µg

Serious events: 5 serious events

Other events: 14 other events

Deaths: 0 deaths

Romiplostim 750 µg

Serious events: 4 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

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

Serious adverse events
Measure	Placebo n=9 participants at risk	Romiplostim 500 µg n=14 participants at risk	Romiplostim 750 µg n=14 participants at risk
Blood and lymphatic system disorders Anaemia	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	14.3% 2/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Blood and lymphatic system disorders Leukopenia	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Blood and lymphatic system disorders Neutropenia	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	21.4% 3/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Cardiac disorders Angina pectoris	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Cardiac disorders Bradycardia	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Gastrointestinal disorders Diarrhoea	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Gastrointestinal disorders Nausea	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Gastrointestinal disorders Vomiting	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
General disorders Pyrexia	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Infections and infestations Bacteraemia	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Infections and infestations Cellulitis	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Infections and infestations Staphylococcal sepsis	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	14.3% 2/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Musculoskeletal and connective tissue disorders Bone pain	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Musculoskeletal and connective tissue disorders Muscular weakness	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Nervous system disorders Cerebrovascular accident	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Renal and urinary disorders Renal failure acute	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Vascular disorders Thrombophlebitis	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.

Other adverse events
Measure	Placebo n=9 participants at risk	Romiplostim 500 µg n=14 participants at risk	Romiplostim 750 µg n=14 participants at risk
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Gastrointestinal disorders Gingival bleeding	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Gastrointestinal disorders Haematochezia	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Gastrointestinal disorders Lip ulceration	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Gastrointestinal disorders Nausea	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	21.4% 3/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	35.7% 5/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Gastrointestinal disorders Oral pain	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Blood and lymphatic system disorders Anaemia	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Blood and lymphatic system disorders Febrile neutropenia	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Blood and lymphatic system disorders Haematotoxicity	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Blood and lymphatic system disorders Leukopenia	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Blood and lymphatic system disorders Neutropenia	33.3% 3/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	28.6% 4/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Blood and lymphatic system disorders Pancytopenia	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Blood and lymphatic system disorders Thrombocytopenia	33.3% 3/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	28.6% 4/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	14.3% 2/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	14.3% 2/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Cardiac disorders Atrial fibrillation	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Ear and labyrinth disorders Ear congestion	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Ear and labyrinth disorders Ear pain	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Ear and labyrinth disorders Tinnitus	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Gastrointestinal disorders Abdominal discomfort	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Gastrointestinal disorders Abdominal pain upper	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Gastrointestinal disorders Constipation	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	35.7% 5/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Gastrointestinal disorders Diarrhoea	44.4% 4/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	28.6% 4/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	35.7% 5/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Gastrointestinal disorders Dry mouth	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	14.3% 2/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Gastrointestinal disorders Dyspepsia	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Gastrointestinal disorders Faeces hard	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
General disorders Asthenia	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
General disorders Catheter site haemorrhage	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
General disorders Catheter site pain	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
General disorders Chills	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
General disorders Fatigue	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	28.6% 4/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	57.1% 8/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
General disorders Feeling cold	11.1% 1/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
General disorders Gait disturbance	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
General disorders Non-cardiac chest pain	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
General disorders Oedema	0.00% 0/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	7.1% 1/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	0.00% 0/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.
General disorders Oedema peripheral	33.3% 3/9 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	35.7% 5/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.	21.4% 3/14 • Up to 21 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.