Trial Outcomes & Findings for Romiplostim Treatment of Thrombocytopenia in Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) (NCT NCT00614523)
NCT ID: NCT00614523
Last Updated: 2022-11-07
Results Overview
A clinically significant bleeding event is defined as any bleeding event of grade ≥ 2 per the modified World Health Organization (WHO) bleeding scale: • Grade 0 = no bleeding • Grade 1 = petechia or mucosal or retinal bleeding not requiring intervention • Grade 2 = melena, hematemesis, hematuria, hemoptysis • Grade 3 = bleeding required red cell transfusion • Grade 4 = retinal bleeding with visual impairment • Grade 5 = non-fatal cerebral bleeding • Grade 6 = fatal cerebral bleeding • Grade 7 = fatal non-cerebral bleeding. Bleeding events that continue for more than 7 days were counted as separate events every eighth day. Multiple events that arose from one organ system on one day were collapsed into one single event. Bleeding events with a start date between the first dose date and the last dose date of the test treatment period+7 days are included.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
250 participants
Primary outcome timeframe
Test Treatment Period (Weeks 1-26)
Results posted on
2022-11-07
Participant Flow
First Subject Enrolled: 21 July 2008, Last Subject Enrolled: 16 December 2010.
Participant milestones
| Measure |
Placebo
Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
|
Romiplostim
Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
167
|
|
Overall Study
COMPLETED
|
20
|
36
|
|
Overall Study
NOT COMPLETED
|
63
|
131
|
Reasons for withdrawal
| Measure |
Placebo
Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
|
Romiplostim
Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
20
|
|
Overall Study
Death
|
5
|
8
|
|
Overall Study
Lack of Efficacy
|
9
|
11
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
12
|
22
|
|
Overall Study
Other
|
6
|
11
|
|
Overall Study
Ineligibility Determined
|
1
|
2
|
|
Overall Study
Disease Progression
|
0
|
8
|
|
Overall Study
Administrative Decision
|
23
|
46
|
Baseline Characteristics
Romiplostim Treatment of Thrombocytopenia in Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Baseline characteristics by cohort
| Measure |
Placebo
n=83 Participants
Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
|
Romiplostim
n=167 Participants
Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 12 • n=7 Participants
|
67.9 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
79 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
235 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Myelodysplastic Syndromes World Health Organization Classification
RA
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Myelodysplastic Syndromes World Health Organization Classification
RARS
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Myelodysplastic Syndromes World Health Organization Classification
RAEB-1
|
9 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Myelodysplastic Syndromes World Health Organization Classification
RAEB-2
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Myelodysplastic Syndromes World Health Organization Classification
RCMD
|
55 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Myelodysplastic Syndromes World Health Organization Classification
RCMD-RS
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Myelodysplastic Syndromes World Health Organization Classification
MDS-U
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Myelodysplastic Syndromes World Health Organization Classification
MDS associated with isolated del 5Q
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Prior MDS Therapy
No
|
70 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Prior MDS Therapy
Yes
|
13 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Baseline Platelet Counts
|
21.5 10^9/L
STANDARD_DEVIATION 13 • n=5 Participants
|
22.3 10^9/L
STANDARD_DEVIATION 11.5 • n=7 Participants
|
22.0 10^9/L
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
International Prognostic Scoring System (IPSS) Total Score
0
|
23 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
International Prognostic Scoring System (IPSS) Total Score
0.5
|
38 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
International Prognostic Scoring System (IPSS) Total Score
1
|
20 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
International Prognostic Scoring System (IPSS) Total Score
1.5
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
International Prognostic Scoring System (IPSS) Total Score
Missing
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Test Treatment Period (Weeks 1-26)Population: Full analysis set includes all randomized patients.
A clinically significant bleeding event is defined as any bleeding event of grade ≥ 2 per the modified World Health Organization (WHO) bleeding scale: • Grade 0 = no bleeding • Grade 1 = petechia or mucosal or retinal bleeding not requiring intervention • Grade 2 = melena, hematemesis, hematuria, hemoptysis • Grade 3 = bleeding required red cell transfusion • Grade 4 = retinal bleeding with visual impairment • Grade 5 = non-fatal cerebral bleeding • Grade 6 = fatal cerebral bleeding • Grade 7 = fatal non-cerebral bleeding. Bleeding events that continue for more than 7 days were counted as separate events every eighth day. Multiple events that arose from one organ system on one day were collapsed into one single event. Bleeding events with a start date between the first dose date and the last dose date of the test treatment period+7 days are included.
Outcome measures
| Measure |
Placebo
n=83 Participants
Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
|
Romiplostim
n=167 Participants
Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
|
|---|---|---|
|
Number of Clinically Significant Bleeding Events
|
116 events
|
178 events
|
SECONDARY outcome
Timeframe: Test Treatment Period (Weeks 1-26)Population: Full analysis set includes all randomized patients.
A discrete platelet transfusion is any number of platelet transfusion administered within a 3-day period. Transfusions administered more than 3 days apart are counted as separate events. Transfusion given in the absence of any bleeding, when platelet count is \>10x10\^9/L, is not counted as a platelet transfusion event. Events with start date between the first dose date and the last dose date of the test treatment period +7 days are included. Exposure adjusted event rate per 100 patient-years = (events / patient-years \* 100). Patient Year = total patient years of exposure to investigational product during 26 weeks test treatment period.
Outcome measures
| Measure |
Placebo
n=83 Participants
Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
|
Romiplostim
n=167 Participants
Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
|
|---|---|---|
|
Annualized Rate of Platelet Transfusion Events
|
1013.5 events per 100 patient-years
Interval 905.2 to 1131.3
|
748.9 events per 100 patient-years
Interval 681.3 to 821.4
|
SECONDARY outcome
Timeframe: Test Treatment Period (Weeks 1-26)Population: Full analysis set includes all randomized patients.
The time from first dose of study drug to the last dose of 26-week test treatment period. A bleeding event is defined as any bleeding event reported during the test treatment period. Bleeding events that continue for more than 7 days are counted as separate events every eighth day. Multiple events that arose from one organ system on one day are collapsed into one single event. Exposure adjusted event rate per 100 patient-years = events / patient-year \* 100).
Outcome measures
| Measure |
Placebo
n=83 Participants
Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
|
Romiplostim
n=167 Participants
Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
|
|---|---|---|
|
Annualized Rate of Overall Bleeding Events
|
3786.4 events per 100 patient-years
Interval 3574.1 to 4008.0
|
3459.9 events per 100 patient-years
Interval 3312.8 to 3611.9
|
SECONDARY outcome
Timeframe: Test Treatment Period (Weeks 1-26)Population: Full analysis set includes all randomized subjects
The time from first dose of study drug to the last dose of 26-week test treatment period. A unit of platelets is defined as a single pack of pooled platelet-rich plasma comprised of 6 to 8 individual platelet concentrate packs (200 to 400 mL), a single pack of pooled buffy-coat concentrate, or 1 apheresis (single donor) concentrate. Exposure adjusted event rate per 100 patient-years = events / patient-years \* 100.
Outcome measures
| Measure |
Placebo
n=83 Participants
Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
|
Romiplostim
n=167 Participants
Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
|
|---|---|---|
|
Annualized Rate of Total Platelet Transfusion Units
|
3120.2 units per 100 patient-years
Interval 2927.8 to 3322.0
|
2221.8 units per 100 patient-years
Interval 2104.2 to 2344.2
|
SECONDARY outcome
Timeframe: Test Treatment Period (Weeks 1-26)Population: Full analysis set includes all randomized patients.
Platelet Hematologic Improvemen defined by the international working group (IWG) as: an absolute increase in platelet count of ≥ 30 x 10\^9/L for a patient starting with a platelet count of ≥ 20 x 10\^9/L or an increase in platelet count from \< 20 x 10\^9/L to ≥ 20 x 10\^9/L and by at least 100% in a patient that started with a platelet count \< 20 x 10\^9/L. To account for any possible contribution from platelet transfusions, platelet counts within 3 days following administration of platelet transfusion is not counted towards the platelet hematologic improvement endpoint. If no platelet measurements are available on the weekly scheduled dose day, then that week is not counted towards the platelet hematologic improvement endpoint.
Outcome measures
| Measure |
Placebo
n=83 Participants
Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
|
Romiplostim
n=167 Participants
Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
|
|---|---|---|
|
Number of Participants With Platelet Hematologic Improvement (HI-P)
|
3 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: Test Treatment Period (Weeks 1-26)Population: Full analysis set includes all randomized patients.
Duration for participants who did not report HI-P during the period is 0. A platelet hematologic improvement (HI-P) is defined by an MDS International Working criteria as patients with a baseline platelet count of ≥ 20 x 10\^9/L achieving an absolute increase of ≥ 30 x 10\^9/L or increasing the platelet count to above 20 x 10\^9/L and by at least 100% in patients with a baseline of \< 20 x 10\^9/L for at least 8 consecutive weeks. To account for any possible contribution from platelet transfusions, platelet counts within 3 days following administration of platelet transfusion is not counted towards the platelet hematologic improvement endpoint. If no platelet measurements are available on the weekly scheduled dose day, then that week is not counted towards the platelet hematologic improvement endpoint. The durations of HI-P are cumulative if more than one incidence occurred. Exposure adjusted event rate per 100 patient-weeks = total number of weeks / patient-weeks \* 100.
Outcome measures
| Measure |
Placebo
n=83 Participants
Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
|
Romiplostim
n=167 Participants
Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
|
|---|---|---|
|
Exposure-adjusted Total Duration of Platelet Hematologic Improvement (HI-P) in the Absence of Platelet Transfusions
|
2.57 weeks per 100 patient-weeks
Interval 1.85 to 3.47
|
35.02 weeks per 100 patient-weeks
Interval 32.98 to 37.16
|
SECONDARY outcome
Timeframe: From randomization to 58 weeks, the end of study visit or the closest available follow-up information up to 58 weeks from the long term follow-up for those who discontinued the study early, with a data cut-off date of 20 July 2012.Population: Full analysis set includes all randomized patients.
Outcome measures
| Measure |
Placebo
n=83 Participants
Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
|
Romiplostim
n=167 Participants
Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
|
|---|---|---|
|
Number of Participants Who Died
|
17 participants
|
30 participants
|
SECONDARY outcome
Timeframe: From randomization to 58 weeks, the end of study visit or the closest available follow-up information up to 58 weeks from the long term follow-up for those who discontinued the study early, with a data cut-off date of 20 July 2012.Population: Full analysis set includes all randomized patients.
Overall survival was calculated using Kaplan-Meier methods. For patients who discontinued early, additional information from the long term follow-up are added (closest available follow-up information up to 58 weeks).
Outcome measures
| Measure |
Placebo
n=83 Participants
Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
|
Romiplostim
n=167 Participants
Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
|
|---|---|---|
|
Time to Death
|
NA months
Median and confidence intervals were not estimable due to the low number of deaths.
|
NA months
Median and confidence intervals were not estimable due to the low number of deaths.
|
SECONDARY outcome
Timeframe: Month 12, with a data cut-off date of 20 July 2012.Population: Full analysis set includes all randomized patients.
Overall survival was calculated using Kaplan-Meier methods.
Outcome measures
| Measure |
Placebo
n=83 Participants
Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
|
Romiplostim
n=167 Participants
Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
|
|---|---|---|
|
Kaplan-Meier Estimate of Survival at Month 12
|
78 percentage of participants
Interval 67.0 to 86.0
|
83 percentage of participants
Interval 76.0 to 88.0
|
SECONDARY outcome
Timeframe: Test Treatment Period (Weeks 1-26)Population: The Patient Reported Outcomes (PRO) analysis set consists of patients in the full analysis set who also completed the baseline and at least one post-baseline assessment for any PRO measure.
The number of bleeding events was obtained from the thrombocytopenia symptoms (Th-symptoms) survey. Patients reported spontaneous bleeding to have occurred 0, 1 or 2, 3 or 4, 5 or 6, or 7 or more times in the past week. The lower threshold of bleeding counts is used for conservative purposes (i.e., the "3" is used for the response option of "3 or 4 times"). Exposure adjusted event rate per 100 patient-years = number of events / patient-year \* 100.
Outcome measures
| Measure |
Placebo
n=82 Participants
Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
|
Romiplostim
n=162 Participants
Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
|
|---|---|---|
|
Annualized Rate of Patient-reported Bleeding Events
|
1995 events per 100 patient-years
Interval 1840.5 to 2158.9
|
1264 events per 100 patient-years
Interval 1175.1 to 1357.7
|
Adverse Events
Placebo
Serious events: 22 serious events
Other events: 74 other events
Deaths: 0 deaths
Romiplostim
Serious events: 67 serious events
Other events: 146 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=82 participants at risk
Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
|
Romiplostim
n=168 participants at risk
Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
2/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
4.2%
7/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Blood and lymphatic system disorders
Extramedullary haemopoiesis
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
2/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
1.2%
2/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
1.2%
2/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
3.6%
6/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Cardiac disorders
Angina pectoris
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
3.0%
5/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Cardiac disorders
Cardiogenic shock
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Cardiac disorders
Coronary artery stenosis
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
1.2%
2/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
2/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
1.8%
3/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Gastrointestinal disorders
Gingival bleeding
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Gastrointestinal disorders
Haematemesis
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
General disorders
Asthenia
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
1.2%
2/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
General disorders
Fatigue
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
General disorders
General physical health deterioration
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
General disorders
Hernia
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
General disorders
Malaise
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
General disorders
Multi-organ failure
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
General disorders
Pyrexia
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
4.2%
7/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Anal abscess
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
1.2%
2/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Bronchopneumonia
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
1.2%
2/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
1.2%
2/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Escherichia sepsis
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
External ear cellulitis
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Gingival infection
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
1.2%
2/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
4.8%
8/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Pneumonia viral
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Respiratory tract infection
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Sepsis
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
1.8%
3/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Viral pericarditis
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
2.4%
4/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
1.2%
2/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Investigations
Blast cell count increased
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Investigations
Hepatic enzyme increased
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Investigations
Myeloblast count increased
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
1.2%
2/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Investigations
Oxygen saturation decreased
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
1.2%
2/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Osteosclerosis
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Nervous system disorders
Cerebral haemorrhage
|
2.4%
2/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
1.2%
2/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Nervous system disorders
Encephalitis
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Nervous system disorders
Headache
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Nervous system disorders
Syncope
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
1.2%
2/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Nervous system disorders
Wallenberg syndrome
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Renal and urinary disorders
Haematuria
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
2/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
2.4%
4/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Vascular disorders
Haemorrhage
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Vascular disorders
Hypotension
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Vascular disorders
Shock haemorrhagic
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.60%
1/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
Other adverse events
| Measure |
Placebo
n=82 participants at risk
Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
|
Romiplostim
n=168 participants at risk
Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.5%
7/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
9.5%
16/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Eye disorders
Conjunctival haemorrhage
|
6.1%
5/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
5.4%
9/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
5/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
6.0%
10/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Gastrointestinal disorders
Constipation
|
7.3%
6/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
5.4%
9/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.2%
10/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
13.7%
23/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Gastrointestinal disorders
Gingival bleeding
|
17.1%
14/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
19.6%
33/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
9.8%
8/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
12.5%
21/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Gastrointestinal disorders
Nausea
|
8.5%
7/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
16.1%
27/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
5/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
4.8%
8/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
General disorders
Asthenia
|
7.3%
6/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
13.1%
22/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
General disorders
Fatigue
|
8.5%
7/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
14.3%
24/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
General disorders
Injection site haematoma
|
13.4%
11/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
7.1%
12/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
General disorders
Oedema peripheral
|
8.5%
7/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
15.5%
26/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
General disorders
Pyrexia
|
14.6%
12/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
10.1%
17/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
General disorders
Vessel puncture site haematoma
|
7.3%
6/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
3.6%
6/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Nasopharyngitis
|
9.8%
8/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
8.3%
14/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Oral herpes
|
6.1%
5/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
4.2%
7/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
6/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
3.6%
6/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Contusion
|
12.2%
10/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
24.4%
41/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.4%
2/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
10.1%
17/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
3/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
11.9%
20/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
6/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
8.9%
15/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.2%
1/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
5.4%
9/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.7%
3/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
8.9%
15/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.1%
5/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
2.4%
4/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.1%
5/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
10.1%
17/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Nervous system disorders
Dizziness
|
7.3%
6/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
9.5%
16/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Nervous system disorders
Headache
|
12.2%
10/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
17.3%
29/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Nervous system disorders
Syncope
|
6.1%
5/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Psychiatric disorders
Insomnia
|
2.4%
2/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
7.7%
13/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.2%
10/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
14.9%
25/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.9%
4/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
7.7%
13/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
39.0%
32/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
39.3%
66/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.9%
4/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
5.4%
9/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
13.4%
11/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
14.9%
25/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
9.8%
8/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
11.9%
20/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
24.4%
20/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
25.0%
42/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.3%
6/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
6.0%
10/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.2%
10/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
7.1%
12/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Vascular disorders
Capillary fragility
|
6.1%
5/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
0.00%
0/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Vascular disorders
Haematoma
|
40.2%
33/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
34.5%
58/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
|
Vascular disorders
Haemorrhage
|
18.3%
15/82 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
14.3%
24/168 • 58 weeks
The safety analysis set consisted of 250 patients including 168 in the romiplostim group and 82 in the placebo group. One patient enrolled in the placebo group received 1 dose of romiplostim at week 4 of the extended treatment period. Results for this patient were analyzed as part of the romiplostim group in the Safety Analysis Set.
|
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 resul
- Publication restrictions are in place
Restriction type: OTHER