Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim

• Sponsor: Amgen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01143038
• Collaborator: (none)
• Enrollment: 75
• Locations: 48
• Arm: 1
• Actual Duration (Months): 36.9
• Patients Per Site: 1.6
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to describe the number of months with a platelet response over a 12 month treatment period and to describe ITP remission rates in adults with ITP receiving romiplostim.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Thrombocytopenic Purpura	Biological: Romiplostim	Phase 2

Detailed Description

The study includes a 4-week screening period, a 12-month romiplostim treatment period, and a romiplostim dose-tapering period.

During the 12-month treatment period romiplostim doses could be increased or decreased to maintain a platelet count between ≥ 50 x 10^{9/L and ≤ 200 x 10}9/L. Participants who dose reduce such that they no longer require treatment with romiplostim during the 12-month treatment period will continue with all required study procedures up to 12 months and will be monitored for ITP remission for at least 6 months.

At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^{9/L will enter the tapering period, during which the romiplostim dose will be decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. If a participant maintains a platelet count of ≥ 50 x 10}9/L in the absence of romiplostim and all medications for ITP (concomitant or rescue), the participant will be followed for at least 6 months to confirm the incidence of ITP remission. If a participant's platelet count falls below 50 x 10^9/L and the participant has tapered off treatment with romiplostim, the participant will enter the stabilization period and reinitiate romiplostim for up to 8 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Interventional Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim
• Actual Study Start Date: Nov 30, 2010
• Actual Primary Completion Date: Sep 20, 2013
• Actual Study Completion Date: Dec 26, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Romiplostim Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases continued in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.	Biological: Romiplostim; Romiplostim will be administered weekly by subcutaneous injection; Other Names: AMG 531 Nplate

Outcome Measures

Primary Outcome Measures

1. Number of Months With Platelet Response During the 12-Month Treatment Period [12 months]

   The primary endpoint was the number of months a participant achieved a platelet response during the 12-month treatment period. A platelet response for any 1 month was defined as the median of platelet counts measured in the month ≥ 50 x 10^9/L. Platelet counts within 4 weeks following a rescue medication use or following splenectomy were considered non-response. Months without any platelet count measurement were considered as months with no platelet response.

Secondary Outcome Measures

1. Percentage of Participants With ITP Remission [Up to 24 months]

   ITP remission was defined as maintaining every platelet count ≥ 50 x 10^9/L for at least 6 months in the absence of romiplostim and any other therapies to treat ITP.

2. Percentage of Participants With Splenectomy During the 12-month Treatment Period [12 months]

   If treatment with romiplostim was deemed ineffective or intolerable by the investigator, a splenectomy may have been performed.

3. Number of Participants With Adverse Events [From first dose date of romiplostim to end of study (up to 24 months).]

   An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other significant medical hazard. Whether an adverse event was treatment-related (TRAE) or not was determined by investigator.

4. Number of Participants Who Developed Antibodies to Romiplostim [Baseline and at end of treatment (based on response to treatment, this could occur between 12 months and approximately 18 months)]

   The number of participants who developed antibody formation (defined as negative at baseline and positive at post-baseline, transient or persistent) to romiplostim, endogenous thrombopoietin (eTPO), and thrombopoietin mimetic peptide (TMP, the peptide component of romiplostim) was summarized.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject has been diagnosed with primary ITP according to the American Society of Hematology (ASH) guidelines (George et al, 1996) and previously received only 1st line therapies.

First line therapy is defined as corticosteroids, immunoglobulin G (IVIG), anti-D and vinca alkaloids (used for the treatment of ITP related thrombocytopenia only). A platelet transfusion at any time during the six month period since the original diagnosis would not exclude the subject from study participation

• Initial diagnosis of primary ITP within 6 months of enrollment

• Age ≥ 18 years at screening

• A single platelet count ≤ 30 x 10⁹/L at any time during the screening period

• Subject or subject's legally acceptable representative has provided informed consent

Exclusion Criteria:

• Known history of a bone marrow stem cell disorder

• Surgical resection of the spleen

• Subject has a history of cancer or current malignancy other than basal cell carcinoma or cervical cancer in-situ with active treatment or disease within 5 years of screening

• Known history of congenital thrombocytopenia

• Known history of hepatitis B, hepatitis C, or human immunodeficiency virus

• Positive H. pylori by urea breath test or stool antigen test at screening

• Known history of systemic lupus erythematosus, Evans syndrome, or autoimmune neutropenia

• Known history of antiphospholipid antibody syndrome or positive for lupus anticoagulant

• Known history of disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura

• Previous history of recurrent venous thromboembolism or thrombotic events or an occurrence within 5 years of enrollment.

• Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), eltrombopag, recombinant human thrombopoietin (rHuTPO) or any platelet producing agent

• Rituximab (for any indication) or mercaptopurine (6-MP) or anticipated use during the time of the proposed study

• All hematopoietic growth factors including interleukin-11 (IL-11) (oprelvekin) within 4 weeks before the screening visit

• Alkylating agents use at any time before or during the screening visit or anticipated during the time of the proposed study

• Known hypersensitivity to any recombinant E. coli-derived product (eg, Infergen, Neupogen, Somatropin, and Actimmune)

• Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)

• Subject will have any other investigational procedures performed while enrolled in this clinical study

• Subject is pregnant or breast feeding, or planning to become pregnant within 5 weeks after the end of treatment

• Female subject of child bearing potential is not willing to use, in combination with her partner, highly effective contraception during treatment and for 4 weeks after the end of treatment

• Subject has previously enrolled into a romiplostim study

• Subject will not be available for protocol required study visits, to the best of the subject's and investigator's knowledge

• Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Anaheim	California	United States	92801
2	Research Site	Orange	California	United States	92868
3	Research Site	Boynton Beach	Florida	United States	33435
4	Research Site	Bethesda	Maryland	United States	20817
5	Research Site	Hickory	North Carolina	United States	28602
6	Research Site	Philadelphia	Pennsylvania	United States	19140
7	Research Site	Charleston	South Carolina	United States	29414
8	Research Site	Richlands	Virginia	United States	24641
9	Research Site	Randwick	New South Wales	Australia	2031
10	Research Site	Woolloongabba	Queensland	Australia	4102
11	Research Site	Adelaide	South Australia	Australia	5000
12	Research Site	Brno		Czechia	625 00
13	Research Site	Ostrava-Poruba		Czechia	708 52
14	Research Site	Praha 10		Czechia	100 34
15	Research Site	Praha 2		Czechia	128 08
16	Research Site	Praha 2		Czechia	128 20
17	Research Site	Bondy Cedex		France	93143
18	Research Site	Créteil Cedex		France	94010
19	Research Site	Dijon		France	21000
20	Research Site	Pessac Cedex		France	33604
21	Research Site	Toulouse Cedex 9		France	31059
22	Research Site	Dresden		Germany	01307
23	Research Site	Duisburg		Germany	47166
24	Research Site	Düsseldorf		Germany	40479
25	Research Site	Köln		Germany	50674
26	Research Site	Bari		Italy	70124
27	Research Site	Catania		Italy	95124
28	Research Site	Monza (MB)		Italy	20900
29	Research Site	Napoli		Italy	80131
30	Research Site	Novara		Italy	28100
31	Research Site	Roma		Italy	00161
32	Research Site	San Giovanni Rotondo FG		Italy	71013
33	Research Site	Vicenza		Italy	36100
34	Research Site	Gdansk		Poland	80-952
35	Research Site	Katowice		Poland	40-032
36	Research Site	Lublin		Poland	20-080
37	Research Site	Poznan		Poland	61-505
38	Research Site	Wroclaw		Poland	50-367
39	Research Site	Málaga	Andalucía	Spain	29010
40	Research Site	Barcelona	Cataluña	Spain	08035
41	Research Site	A Coruña	Galicia	Spain	15006
42	Research Site	Alcorcon	Madrid	Spain	28922
43	Research Site	Majadahonda	Madrid	Spain	28222
44	Research Site	Coventry		United Kingdom	CV2 2DX
45	Research Site	Leeds		United Kingdom	LS9 7TF
46	Research Site	London		United Kingdom	E1 2ES
47	Research Site	London		United Kingdom	SW17 0QT
48	Research Site	Oxford		United Kingdom	OX3 9DU

Sponsors and Collaborators

• Amgen

Investigators

• Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• AmgenTrials clinical trials website

Publications

• Cines DB, Wasser J, Rodeghiero F, Chong BH, Steurer M, Provan D, Lyons R, Garcia-Chavez J, Carpenter N, Wang X, Eisen M. Safety and efficacy of romiplostim in splenectomized and nonsplenectomized patients with primary immune thrombocytopenia. Haematologica. 2017 Aug;102(8):1342-1351. doi: 10.3324/haematol.2016.161968. Epub 2017 Apr 14.
• Kuter DJ, Newland A, Chong BH, Rodeghiero F, Romero MT, Pabinger I, Chen Y, Wang K, Mehta B, Eisen M. Romiplostim in adult patients with newly diagnosed or persistent immune thrombocytopenia (ITP) for up to 1 year and in those with chronic ITP for more than 1 year: a subgroup analysis of integrated data from completed romiplostim studies. Br J Haematol. 2019 May;185(3):503-513. doi: 10.1111/bjh.15803. Epub 2019 Feb 21.
• Newland A, Godeau B, Priego V, Viallard JF, López Fernández MF, Orejudos A, Eisen M. Remission and platelet responses with romiplostim in primary immune thrombocytopenia: final results from a phase 2 study. Br J Haematol. 2016 Jan;172(2):262-73. doi: 10.1111/bjh.13827. Epub 2015 Nov 5.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT01143038
• Other Study ID Numbers: 20080435; 2010-019987-35
• First Posted: Jun 14, 2010
• Last Update Posted: May 22, 2019
• Last Verified: May 1, 2019

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

Study Results

Participant Flow

Recruitment Details	Ninety-eight adults with immune thrombocytopenia purpura (ITP) were screened for the study; 23 were considered screen failures. Seventy-five participants were enrolled at 32 study centers in Australia, the European Union, and North America from 30 November 2010 to 21 September 2012.
Pre-assignment Detail	The study included a 12-month romiplostim treatment period, and a romiplostim dose-tapering period. Participants who maintained a platelet count of ≥ 50 x 10^9/L in the absence of romiplostim and all medications for ITP (concomitant or rescue) were followed for at least 6 months to confirm the incidence of ITP remission.

Arm/Group Title	Romiplostim
Arm/Group Description	Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
Period Title: Overall Study
STARTED	75
COMPLETED	59
NOT COMPLETED	16

Baseline Characteristics

Arm/Group Title	Romiplostim
Arm/Group Description	Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
Overall Participants	75
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.5 (18.7)
Sex: Female, Male (Count of Participants)
Female	44 58.7%
Male	31 41.3%
Race (participants) [Number]
American Indian or Alaska Native	0 0%
Asian	1 1.3%
Black (or African American)	1 1.3%
Native Hawaiian or Other Pacific Islander	0 0%
White	72 96%
Other	0 0%
Unknown	1 1.3%
Ethnicity (participants) [Number]
Hispanic/Latino	6 8%
Not Hispanic/Latino	69 92%
Time since ITP diagnosis (months) [Median (Full Range) ]
Median (Full Range) [months]	2.2
Platelet Count at Screening (x 10^9/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [x 10^9/L]	19.78 (15.80)

Outcome Measures

1. Primary Outcome

Title	Number of Months With Platelet Response During the 12-Month Treatment Period
Description	The primary endpoint was the number of months a participant achieved a platelet response during the 12-month treatment period. A platelet response for any 1 month was defined as the median of platelet counts measured in the month ≥ 50 x 10^9/L. Platelet counts within 4 weeks following a rescue medication use or following splenectomy were considered non-response. Months without any platelet count measurement were considered as months with no platelet response.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Safety Analysis Set includes all participants who received at least 1 dose of romiplostim.

Arm/Group Title	Romiplostim
Arm/Group Description	Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
Measure Participants	75
Mean (Standard Error) [months]	9.2 (0.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Romiplostim
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	9.2
	Confidence Interval	(2-Sided) 95%; 8.3 to 10.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Based on the t-distribution

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Romiplostim
	Comments	Bootstrap analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Bootstrap mean
	Estimated Value	9.1
	Confidence Interval	(2-Sided) 95%; 8.3 to 10.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.4
	Estimation Comments	Estimates are based on bootstrap method with 1000 samples with replacement.

2. Secondary Outcome

Title	Percentage of Participants With ITP Remission
Description	ITP remission was defined as maintaining every platelet count ≥ 50 x 10^9/L for at least 6 months in the absence of romiplostim and any other therapies to treat ITP.
Time Frame	Up to 24 months

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Romiplostim
Arm/Group Description	Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
Measure Participants	75
Number (95% Confidence Interval) [percentage of participants]	32.0 42.7%

3. Secondary Outcome

Title	Percentage of Participants With Splenectomy During the 12-month Treatment Period
Description	If treatment with romiplostim was deemed ineffective or intolerable by the investigator, a splenectomy may have been performed.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Romiplostim
Arm/Group Description	Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
Measure Participants	75
Number (95% Confidence Interval) [percentage of participants]	1.3 1.7%

4. Secondary Outcome

Title	Number of Participants With Adverse Events
Description	An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other significant medical hazard. Whether an adverse event was treatment-related (TRAE) or not was determined by investigator.
Time Frame	From first dose date of romiplostim to end of study (up to 24 months).

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Romiplostim
Arm/Group Description	Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
Measure Participants	75
All adverse events	63 84%
Serious adverse events	17 22.7%
Leading to discontinuation of romiplostim	4 5.3%
Leading to discontinuation from study	3 4%
Fatal adverse events	0 0%
Treatment-related adverse event	21 28%
Treatment-related serious adverse events	3 4%
TRAE leading to discontinuation of romiplostim	2 2.7%
TRAE leading to discontinuation from study	2 2.7%
Treatment-related fatal adverse events	0 0%

5. Secondary Outcome

Title	Number of Participants Who Developed Antibodies to Romiplostim
Description	The number of participants who developed antibody formation (defined as negative at baseline and positive at post-baseline, transient or persistent) to romiplostim, endogenous thrombopoietin (eTPO), and thrombopoietin mimetic peptide (TMP, the peptide component of romiplostim) was summarized.
Time Frame	Baseline and at end of treatment (based on response to treatment, this could occur between 12 months and approximately 18 months)

Outcome Measure Data

Analysis Population Description

Safety analysis set participants with available results

Arm/Group Title	Romiplostim
Arm/Group Description	Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
Measure Participants	69
Antibodies to romiplostim	2 2.7%
Antibodies to TPO	1 1.3%
Antibodies to TMP	2 2.7%
Neutralizing antibodies to romiplostim	1 1.3%
Neutralizing antibodies to TPO	0 0%
Neutralizing antibodies to TMP	0 0%

Adverse Events

Time Frame	From first dose date of romiplostim to end of study (up to 24 months).
Adverse Event Reporting Description	Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Arm/Group Title	Romiplostim
Arm/Group Description	Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
All Cause Mortality
	Romiplostim
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Romiplostim
	Affected / at Risk (%)	# Events
Total	17/75 (22.7%)
Blood and lymphatic system disorders
Idiopathic Thrombocytopenic Purpura	1/75 (1.3%)
Thrombocytopenia	1/75 (1.3%)
Cardiac disorders
Atrial Fibrillation	1/75 (1.3%)
Endocrine disorders
Hypothyroidism	1/75 (1.3%)
Gastrointestinal disorders
Abdominal Pain	1/75 (1.3%)
Faecaloma	1/75 (1.3%)
Gastritis	1/75 (1.3%)
Infections and infestations
Erysipelas	1/75 (1.3%)
Injury, poisoning and procedural complications
Tendon Rupture	1/75 (1.3%)
Investigations
Transaminases Increased	1/75 (1.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma	1/75 (1.3%)
Papillary Thyroid Cancer	1/75 (1.3%)
Nervous system disorders
Reversible Ischaemic Neurological Deficit	1/75 (1.3%)
Psychiatric disorders
Delirium Tremens	1/75 (1.3%)
Renal and urinary disorders
Renal Failure Acute	1/75 (1.3%)
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain	1/75 (1.3%)
Skin and subcutaneous tissue disorders
Dapsone Syndrome	1/75 (1.3%)
Vascular disorders
Peripheral Vascular Disorder	1/75 (1.3%)
Other (Not Including Serious) Adverse Events
	Romiplostim
	Affected / at Risk (%)	# Events
Total	50/75 (66.7%)
Ear and labyrinth disorders
Vertigo	4/75 (5.3%)
Eye disorders
Conjunctivitis	4/75 (5.3%)
Gastrointestinal disorders
Diarrhoea	4/75 (5.3%)
General disorders
Asthenia	5/75 (6.7%)
Fatigue	6/75 (8%)
Infections and infestations
Influenza	7/75 (9.3%)
Nasopharyngitis	10/75 (13.3%)
Rhinitis	4/75 (5.3%)
Upper Respiratory Tract Infection	6/75 (8%)
Musculoskeletal and connective tissue disorders
Arthralgia	11/75 (14.7%)
Myalgia	4/75 (5.3%)
Nervous system disorders
Dizziness	4/75 (5.3%)
Headache	13/75 (17.3%)
Respiratory, thoracic and mediastinal disorders
Cough	7/75 (9.3%)
Epistaxis	6/75 (8%)
Skin and subcutaneous tissue disorders
Petechiae	7/75 (9.3%)
Pruritus	4/75 (5.3%)
Rash	4/75 (5.3%)
Vascular disorders
Haematoma	8/75 (10.7%)
Hypertension	6/75 (8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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