Trial Outcomes & Findings for RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag (NCT NCT00370331)
NCT ID: NCT00370331
Last Updated: 2017-04-18
Results Overview
The percentage of evaluable participants who achieved a platelet response (defined as a platelet count between 50,000 and 400,000 microliter) at each nominal on-therapy day and 4 weeks post-treatment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
197 participants
Primary outcome timeframe
Baseline; each on-therapy treatment day; Weeks 10, 14, 18, 22, and 26; and Weeks 1, 2, and 4 post-treatment
Results posted on
2017-04-18
Participant Flow
Participant milestones
| Measure |
Placebo
Matching placebo tablets taken once a day
|
Eltrombopag 50 mg QD
Eltrombopag 50 mg oral tablets taken once a day (QD)
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
135
|
|
Overall Study
COMPLETED
|
55
|
112
|
|
Overall Study
NOT COMPLETED
|
7
|
23
|
Reasons for withdrawal
| Measure |
Placebo
Matching placebo tablets taken once a day
|
Eltrombopag 50 mg QD
Eltrombopag 50 mg oral tablets taken once a day (QD)
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
13
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Non-compliance
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag
Baseline characteristics by cohort
| Measure |
Placebo
n=62 Participants
Matching placebo tablets taken once a day
|
Eltrombopag 50 mg QD
n=135 Participants
Eltrombopag 50 mg oral tablets taken once a day (QD)
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 14.72 • n=99 Participants
|
46.5 years
STANDARD_DEVIATION 15.61 • n=107 Participants
|
47.9 years
STANDARD_DEVIATION 15.45 • n=206 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American/African
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska native
|
4 participants
n=99 Participants
|
8 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
10 participants
n=99 Participants
|
19 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
South-East Asian
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White/Arabic/North African
|
2 participants
n=99 Participants
|
6 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian/European
|
42 participants
n=99 Participants
|
95 participants
n=107 Participants
|
137 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Stratification variable
Use of ITP medication at randomization
|
31 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Stratification variable
Splenectomy at randomization
|
21 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Stratification variable
Platelet count less or equal 15,000 per microliter
|
30 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline; each on-therapy treatment day; Weeks 10, 14, 18, 22, and 26; and Weeks 1, 2, and 4 post-treatmentPopulation: Intent-to-Treat (ITT) Population: all randomized participants
The percentage of evaluable participants who achieved a platelet response (defined as a platelet count between 50,000 and 400,000 microliter) at each nominal on-therapy day and 4 weeks post-treatment
Outcome measures
| Measure |
Placebo
n=62 Participants
Matching placebo tablets taken once a day
|
Eltrombopag 50 mg QD
n=135 Participants
Eltrombopag 50 mg oral tablets taken once a day (QD)
|
|---|---|---|
|
Percentage of Responders
Day 15
|
8 Percentage of participants
|
46 Percentage of participants
|
|
Percentage of Responders
Day 22
|
8 Percentage of participants
|
51 Percentage of participants
|
|
Percentage of Responders
Week 14
|
18 Percentage of participants
|
46 Percentage of participants
|
|
Percentage of Responders
Week 18
|
17 Percentage of participants
|
46 Percentage of participants
|
|
Percentage of Responders
Week 22
|
19 Percentage of participants
|
49 Percentage of participants
|
|
Percentage of Responders
Week 26
|
17 Percentage of participants
|
52 Percentage of participants
|
|
Percentage of Responders
1 Week Follow-up
|
15 Percentage of participants
|
42 Percentage of participants
|
|
Percentage of Responders
2 Week Follow-up
|
18 Percentage of participants
|
22 Percentage of participants
|
|
Percentage of Responders
4 Week Follow-up
|
14 Percentage of participants
|
20 Percentage of participants
|
|
Percentage of Responders
Baseline
|
2 Percentage of participants
|
1 Percentage of participants
|
|
Percentage of Responders
Day 8
|
7 Percentage of participants
|
37 Percentage of participants
|
|
Percentage of Responders
Day 29
|
10 Percentage of participants
|
49 Percentage of participants
|
|
Percentage of Responders
Day 36
|
8 Percentage of participants
|
56 Percentage of participants
|
|
Percentage of Responders
Day 43
|
14 Percentage of participants
|
54 Percentage of participants
|
|
Percentage of Responders
Week 10
|
17 Percentage of participants
|
52 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Day 8 through Week 26 on-treatment; and 1, 2, 4 week follow-up visitsPopulation: ITT Population
Platelet counts were measured by blood draw.
Outcome measures
| Measure |
Placebo
n=62 Participants
Matching placebo tablets taken once a day
|
Eltrombopag 50 mg QD
n=135 Participants
Eltrombopag 50 mg oral tablets taken once a day (QD)
|
|---|---|---|
|
Summary of Median Platelet Counts
Baseline
|
16,000 platelets/microliter (ul)
Interval 2000.0 to
|
16,000 platelets/microliter (ul)
Interval 0.0 to
|
|
Summary of Median Platelet Counts
Day 8
|
17,500 platelets/microliter (ul)
Interval 3000.0 to
|
36,000 platelets/microliter (ul)
Interval 1000.0 to
|
|
Summary of Median Platelet Counts
Day 15
|
18,000 platelets/microliter (ul)
Interval 2000.0 to
|
54,000 platelets/microliter (ul)
Interval 2000.0 to
|
|
Summary of Median Platelet Counts
Day 22
|
18,500 platelets/microliter (ul)
Interval 1000.0 to
|
54,000 platelets/microliter (ul)
Interval 1000.0 to
|
|
Summary of Median Platelet Counts
Day 29
|
18,000 platelets/microliter (ul)
Interval 3000.0 to
|
53,000 platelets/microliter (ul)
Interval 1000.0 to
|
|
Summary of Median Platelet Counts
Week 14
|
17,500 platelets/microliter (ul)
Interval 1000.0 to
|
60,000 platelets/microliter (ul)
Interval 1000.0 to
|
|
Summary of Median Platelet Counts
Week 18
|
20,500 platelets/microliter (ul)
Interval 2000.0 to
|
61,000 platelets/microliter (ul)
Interval 3000.0 to
|
|
Summary of Median Platelet Counts
Week 22
|
23,000 platelets/microliter (ul)
Interval 1000.0 to
|
72,000 platelets/microliter (ul)
Interval 3000.0 to
|
|
Summary of Median Platelet Counts
Week 26
|
23,000 platelets/microliter (ul)
Interval 2000.0 to
|
73,500 platelets/microliter (ul)
Interval 1000.0 to
|
|
Summary of Median Platelet Counts
1 Week Follow-up
|
19,000 platelets/microliter (ul)
Interval 0.0 to
|
38,500 platelets/microliter (ul)
Interval 1000.0 to
|
|
Summary of Median Platelet Counts
2 Week Follow-up
|
18,000 platelets/microliter (ul)
Interval 1000.0 to
|
21,000 platelets/microliter (ul)
Interval 1000.0 to
|
|
Summary of Median Platelet Counts
4 Week Follow-up
|
18,000 platelets/microliter (ul)
Interval 1000.0 to
|
24,000 platelets/microliter (ul)
Interval 1000.0 to
|
|
Summary of Median Platelet Counts
Day 36
|
19,000 platelets/microliter (ul)
Interval 4000.0 to
|
60,000 platelets/microliter (ul)
Interval 1000.0 to
|
|
Summary of Median Platelet Counts
Day 43
|
20,000 platelets/microliter (ul)
Interval 3000.0 to
|
59,000 platelets/microliter (ul)
Interval 1000.0 to
|
|
Summary of Median Platelet Counts
Week 10
|
20,000 platelets/microliter (ul)
Interval 0.0 to
|
61,500 platelets/microliter (ul)
Interval 1000.0 to
|
SECONDARY outcome
Timeframe: Anytime from Day 1 to Week 26Population: All participants randomized to receive placebo or eltrombopag treatment
Percentage of participants initiating new ITP medication, an increased dose of concomitant ITP medication from baseline, platelet transfusion, or splenectomy.
Outcome measures
| Measure |
Placebo
n=62 Participants
Matching placebo tablets taken once a day
|
Eltrombopag 50 mg QD
n=135 Participants
Eltrombopag 50 mg oral tablets taken once a day (QD)
|
|---|---|---|
|
Percentage of Participants Initiating Rescue Treatment On-therapy
Participants who received rescue treatment
|
40 Percentage of participants
|
18 Percentage of participants
|
|
Percentage of Participants Initiating Rescue Treatment On-therapy
Participants who did not receive rescue treatment
|
60 Percentage of participants
|
82 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 through Week 26 on-treatmentPopulation: ITT Population
Response is defined as a platelet count between 50,000 and 400,000 platelets per microliter.
Outcome measures
| Measure |
Placebo
n=62 Participants
Matching placebo tablets taken once a day
|
Eltrombopag 50 mg QD
n=135 Participants
Eltrombopag 50 mg oral tablets taken once a day (QD)
|
|---|---|---|
|
Maximum and Total Weeks of Platelet Response
Maximum continuous Response
|
0 Weeks
Interval 0.0 to 25.0
|
8.1 Weeks
Interval 0.0 to 26.0
|
|
Maximum and Total Weeks of Platelet Response
Cumulative Response
|
0 Weeks
Interval 0.0 to 25.0
|
10.9 Weeks
Interval 0.0 to 26.0
|
SECONDARY outcome
Timeframe: From Day 1 through Week 26 on-treatmentPopulation: ITT Population
Percentage of participants who experienced a reduction in their baseline concomitant ITP medication use
Outcome measures
| Measure |
Placebo
n=60 Participants
Matching placebo tablets taken once a day
|
Eltrombopag 50 mg QD
n=134 Participants
Eltrombopag 50 mg oral tablets taken once a day (QD)
|
|---|---|---|
|
Percentage of Participants With a Reduction in Use of Baseline ITP Medication
Participants who reduced/discontinued ITP therapy
|
32 Percentage of participants
|
59 Percentage of participants
|
|
Percentage of Participants With a Reduction in Use of Baseline ITP Medication
Participants not reducing/discont. ITP therapy
|
68 Percentage of participants
|
41 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, all nominal visits on-therapy defined as Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Week 10, Week 14, Week 18, Week 22, Week 26, and 1, 2 and 4 week follow-up visitsPopulation: ITT Population
Summary of World Health Organization (WHO) bleeding scores at each nominal visit. WHO Grades 1-4 = any bleeding; WHO Grades 2-4 = clinically significant bleeding
Outcome measures
| Measure |
Placebo
n=62 Participants
Matching placebo tablets taken once a day
|
Eltrombopag 50 mg QD
n=135 Participants
Eltrombopag 50 mg oral tablets taken once a day (QD)
|
|---|---|---|
|
WHO Bleeding Scale
Week 22, WHO Grades 1-4
|
46 Percentage of participants
|
18 Percentage of participants
|
|
WHO Bleeding Scale
Week 26, WHO Grades 1-4
|
56 Percentage of participants
|
22 Percentage of participants
|
|
WHO Bleeding Scale
1 Week Follow-up, WHO Grades 1-4
|
59 Percentage of participants
|
28 Percentage of participants
|
|
WHO Bleeding Scale
2 Week Follow-up, WHO Grades 1-4
|
56 Percentage of participants
|
50 Percentage of participants
|
|
WHO Bleeding Scale
4 Week Follow-up, WHO Grades 1-4
|
59 Percentage of participants
|
46 Percentage of participants
|
|
WHO Bleeding Scale
Baseline, WHO Grades 2-4
|
28 Percentage of participants
|
22 Percentage of participants
|
|
WHO Bleeding Scale
Day 8, WHO Grades 2-4
|
20 Percentage of participants
|
16 Percentage of participants
|
|
WHO Bleeding Scale
Day 15, WHO Grades 2-4
|
22 Percentage of participants
|
8 Percentage of participants
|
|
WHO Bleeding Scale
Day 22, WHO Grades 2-4
|
21 Percentage of participants
|
11 Percentage of participants
|
|
WHO Bleeding Scale
Day 29, WHO Grades 2-4
|
19 Percentage of participants
|
10 Percentage of participants
|
|
WHO Bleeding Scale
Day 36, WHO Grades 2-4
|
19 Percentage of participants
|
7 Percentage of participants
|
|
WHO Bleeding Scale
Week 14, WHO Grades 2-4
|
17 Percentage of participants
|
5 Percentage of participants
|
|
WHO Bleeding Scale
Week 18, WHO Grades 2-4
|
18 Percentage of participants
|
2 Percentage of participants
|
|
WHO Bleeding Scale
Week 22, WHO Grades 2-4
|
10 Percentage of participants
|
8 Percentage of participants
|
|
WHO Bleeding Scale
Week 26, WHO Grades 2-4
|
15 Percentage of participants
|
7 Percentage of participants
|
|
WHO Bleeding Scale
1 Week Follow-up, WHO Grades 2-4
|
20 Percentage of participants
|
11 Percentage of participants
|
|
WHO Bleeding Scale
2 Week Follow-up, WHO Grades 2-4
|
18 Percentage of participants
|
16 Percentage of participants
|
|
WHO Bleeding Scale
4 Week Follow-up, WHO Grades 2-4
|
21 Percentage of participants
|
13 Percentage of participants
|
|
WHO Bleeding Scale
Baseline, WHO Grades 1-4
|
77 Percentage of participants
|
73 Percentage of participants
|
|
WHO Bleeding Scale
Day 8, WHO Grades 1-4
|
73 Percentage of participants
|
56 Percentage of participants
|
|
WHO Bleeding Scale
Day 15, WHO Grades 1-4
|
68 Percentage of participants
|
39 Percentage of participants
|
|
WHO Bleeding Scale
Day 22, WHO Grades 1-4
|
67 Percentage of participants
|
38 Percentage of participants
|
|
WHO Bleeding Scale
Day 29, WHO Grades 1-4
|
56 Percentage of participants
|
37 Percentage of participants
|
|
WHO Bleeding Scale
Day 36, WHO Grades 1-4
|
66 Percentage of participants
|
23 Percentage of participants
|
|
WHO Bleeding Scale
Day 43, WHO Grades 1-4
|
59 Percentage of participants
|
23 Percentage of participants
|
|
WHO Bleeding Scale
Week 10, WHO Grades 1-4
|
49 Percentage of participants
|
22 Percentage of participants
|
|
WHO Bleeding Scale
Week 14, WHO Grades 1-4
|
57 Percentage of participants
|
23 Percentage of participants
|
|
WHO Bleeding Scale
Week 18, WHO Grades 1-4
|
59 Percentage of participants
|
22 Percentage of participants
|
|
WHO Bleeding Scale
Day 43, WHO Grades 2-4
|
19 Percentage of participants
|
5 Percentage of participants
|
|
WHO Bleeding Scale
Week 10, WHO Grades 2-4
|
13 Percentage of participants
|
9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 14, and Week 26/Early WithdrawalPopulation: ITT Population
Health-related quality of life (HR-QoL) patient reported outcomes from the short form-36v2 (SF-36v2) questionnaire. Scores could range from 0 (worst possible) to 100 (best possible).
Outcome measures
| Measure |
Placebo
n=62 Participants
Matching placebo tablets taken once a day
|
Eltrombopag 50 mg QD
n=135 Participants
Eltrombopag 50 mg oral tablets taken once a day (QD)
|
|---|---|---|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 physical function, Baseline
|
75.0 Points on a scale (0-100)
Standard Deviation 21.7
|
73.1 Points on a scale (0-100)
Standard Deviation 26.8
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 physical function, Week 6
|
76.5 Points on a scale (0-100)
Standard Deviation 20.8
|
78.0 Points on a scale (0-100)
Standard Deviation 24.4
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 physical function, Week 14
|
77.6 Points on a scale (0-100)
Standard Deviation 20.0
|
78.9 Points on a scale (0-100)
Standard Deviation 22.5
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 physical funct., Week 26/Early Withdrawal
|
75.8 Points on a scale (0-100)
Standard Deviation 22.6
|
80.6 Points on a scale (0-100)
Standard Deviation 21.7
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 physical role, Baseline
|
64.5 Points on a scale (0-100)
Standard Deviation 26.7
|
64.5 Points on a scale (0-100)
Standard Deviation 30.5
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 physical role, Week 6
|
66.9 Points on a scale (0-100)
Standard Deviation 25.4
|
73.7 Points on a scale (0-100)
Standard Deviation 27.4
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 physical role, Week 14
|
67.2 Points on a scale (0-100)
Standard Deviation 25.8
|
72.9 Points on a scale (0-100)
Standard Deviation 24.9
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 physical role, Week 26/Early Withdrawal
|
67.5 Points on a scale (0-100)
Standard Deviation 27.1
|
73.7 Points on a scale (0-100)
Standard Deviation 25.4
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 bodily pain, Baseline
|
70.0 Points on a scale (0-100)
Standard Deviation 23.2
|
75.2 Points on a scale (0-100)
Standard Deviation 27.8
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 bodily pain, Week 6
|
69.9 Points on a scale (0-100)
Standard Deviation 25.9
|
78.5 Points on a scale (0-100)
Standard Deviation 25.4
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 general health, Baseline
|
53.7 Points on a scale (0-100)
Standard Deviation 21.8
|
56.0 Points on a scale (0-100)
Standard Deviation 21.3
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 general health, Week 6
|
55.9 Points on a scale (0-100)
Standard Deviation 21.4
|
59.7 Points on a scale (0-100)
Standard Deviation 21.5
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 vitality, Week 14
|
56.8 Points on a scale (0-100)
Standard Deviation 22.3
|
61.0 Points on a scale (0-100)
Standard Deviation 22.4
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 vitality, Week 26/Early Withdrawal
|
57.5 Points on a scale (0-100)
Standard Deviation 22.4
|
60.0 Points on a scale (0-100)
Standard Deviation 23.3
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 social function, Week 26/Early Withdrawal
|
75.0 Points on a scale (0-100)
Standard Deviation 25.8
|
79.0 Points on a scale (0-100)
Standard Deviation 24.2
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 emotional role, Baseline
|
73.4 Points on a scale (0-100)
Standard Deviation 25.4
|
69.1 Points on a scale (0-100)
Standard Deviation 30.9
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 emotional role, Week 6
|
73.1 Points on a scale (0-100)
Standard Deviation 24.6
|
77.5 Points on a scale (0-100)
Standard Deviation 25.9
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 emotional role, Week 14
|
73.3 Points on a scale (0-100)
Standard Deviation 22.9
|
74.1 Points on a scale (0-100)
Standard Deviation 25.2
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 emotional role, Week 26/Early Withdrawal
|
71.5 Points on a scale (0-100)
Standard Deviation 26.5
|
76.9 Points on a scale (0-100)
Standard Deviation 25.4
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 mental health, Baseline
|
70.3 Points on a scale (0-100)
Standard Deviation 18.7
|
68.0 Points on a scale (0-100)
Standard Deviation 21.0
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 mental health, Week 6
|
71.7 Points on a scale (0-100)
Standard Deviation 18.3
|
71.8 Points on a scale (0-100)
Standard Deviation 19.0
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 mental health, Week 14
|
68.6 Points on a scale (0-100)
Standard Deviation 20.4
|
70.6 Points on a scale (0-100)
Standard Deviation 19.3
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v physical component summary, Week 26/EW
|
46.2 Points on a scale (0-100)
Standard Deviation 8.1
|
48.7 Points on a scale (0-100)
Standard Deviation 8.6
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 mental component summary, Week 6
|
46.8 Points on a scale (0-100)
Standard Deviation 10.0
|
47.2 Points on a scale (0-100)
Standard Deviation 11.1
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 mental component summary, Week 14
|
45.3 Points on a scale (0-100)
Standard Deviation 11.1
|
46.2 Points on a scale (0-100)
Standard Deviation 11.3
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 mental component summary, Week 26/EW
|
45.2 Points on a scale (0-100)
Standard Deviation 12.3
|
46.5 Points on a scale (0-100)
Standard Deviation 12.4
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 bodily pain, Week 14
|
68.3 Points on a scale (0-100)
Standard Deviation 24.8
|
77.6 Points on a scale (0-100)
Standard Deviation 25.8
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 bodily pain, Week 26/Early Withdrawal
|
68.5 Points on a scale (0-100)
Standard Deviation 25.0
|
75.7 Points on a scale (0-100)
Standard Deviation 26.6
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 general health, Week 14
|
52.8 Points on a scale (0-100)
Standard Deviation 23.2
|
59.3 Points on a scale (0-100)
Standard Deviation 20.7
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 general health, Week 26/Early Withdrawal
|
53.3 Points on a scale (0-100)
Standard Deviation 24.9
|
57.3 Points on a scale (0-100)
Standard Deviation 23.1
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 vitality, Baseline
|
56.7 Points on a scale (0-100)
Standard Deviation 20.2
|
55.1 Points on a scale (0-100)
Standard Deviation 26.3
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 vitality, Week 6
|
59.0 Points on a scale (0-100)
Standard Deviation 20.0
|
62.1 Points on a scale (0-100)
Standard Deviation 22.7
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 social function, Baseline
|
76.1 Points on a scale (0-100)
Standard Deviation 21.7
|
72.7 Points on a scale (0-100)
Standard Deviation 28.3
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 social function, Week 6
|
78.0 Points on a scale (0-100)
Standard Deviation 21.4
|
77.6 Points on a scale (0-100)
Standard Deviation 26.2
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 social function, Week 14
|
73.4 Points on a scale (0-100)
Standard Deviation 25.8
|
78.4 Points on a scale (0-100)
Standard Deviation 22.6
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 mental health, Week 26/Early Withdrawal
|
68.6 Points on a scale (0-100)
Standard Deviation 22.8
|
70.2 Points on a scale (0-100)
Standard Deviation 21.6
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v physical component summary, Baseline
|
45.6 Points on a scale (0-100)
Standard Deviation 8.3
|
46.9 Points on a scale (0-100)
Standard Deviation 9.7
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v physical component summary, Week 6
|
46.2 Points on a scale (0-100)
Standard Deviation 8.3
|
48.7 Points on a scale (0-100)
Standard Deviation 9.0
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v physical component summary, Week 14
|
46.3 Points on a scale (0-100)
Standard Deviation 8.3
|
49.0 Points on a scale (0-100)
Standard Deviation 8.1
|
|
HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
SF-36v2 mental component summary, Baseline
|
46.4 Points on a scale (0-100)
Standard Deviation 10.1
|
44.3 Points on a scale (0-100)
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 14, and Week 26/Early WithdrawalPopulation: ITT Population
Health-related quality of life (HR-QoL) patient reported outcomes from the functional assessment of chronic illness therapy fatigue (FACIT-F) questionnaire. Scores could range from 0 (worst possible) to 52 (best possible).
Outcome measures
| Measure |
Placebo
n=62 Participants
Matching placebo tablets taken once a day
|
Eltrombopag 50 mg QD
n=135 Participants
Eltrombopag 50 mg oral tablets taken once a day (QD)
|
|---|---|---|
|
HR-QoL Instrument and Domain Scores From the FACIT-F Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
Baseline
|
36.3 Points on a scale (0-52)
Standard Deviation 9.0
|
36.0 Points on a scale (0-52)
Standard Deviation 12.2
|
|
HR-QoL Instrument and Domain Scores From the FACIT-F Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
Week 6
|
38.3 Points on a scale (0-52)
Standard Deviation 8.2
|
39.2 Points on a scale (0-52)
Standard Deviation 9.7
|
|
HR-QoL Instrument and Domain Scores From the FACIT-F Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
Week 14
|
36.9 Points on a scale (0-52)
Standard Deviation 10.2
|
39.5 Points on a scale (0-52)
Standard Deviation 9.9
|
|
HR-QoL Instrument and Domain Scores From the FACIT-F Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
Week 26/Early Withdrawal
|
37.0 Points on a scale (0-52)
Standard Deviation 11.3
|
39.2 Points on a scale (0-52)
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 14, and Week 26/Early WithdrawalPopulation: ITT Population
Health-related quality of life (HR-QoL) patient reported outcomes from the functional assessment of cancer therapy thrombocytopenia (FACT-Th) questionnaire (six selected items). Scores could range from 0 (worst possible) to 24 (best possible).
Outcome measures
| Measure |
Placebo
n=62 Participants
Matching placebo tablets taken once a day
|
Eltrombopag 50 mg QD
n=135 Participants
Eltrombopag 50 mg oral tablets taken once a day (QD)
|
|---|---|---|
|
HR-QoL Instrument and Domain Scores for the FACT-Th Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
Baseline
|
14.8 Points on a scale (0-24)
Standard Deviation 5.8
|
13.5 Points on a scale (0-24)
Standard Deviation 5.8
|
|
HR-QoL Instrument and Domain Scores for the FACT-Th Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
Week 6
|
15.1 Points on a scale (0-24)
Standard Deviation 5.7
|
15.9 Points on a scale (0-24)
Standard Deviation 6.0
|
|
HR-QoL Instrument and Domain Scores for the FACT-Th Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
Week 14
|
15.3 Points on a scale (0-24)
Standard Deviation 5.4
|
16.7 Points on a scale (0-24)
Standard Deviation 5.6
|
|
HR-QoL Instrument and Domain Scores for the FACT-Th Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
Week 26/Early Withdrawal
|
15.3 Points on a scale (0-24)
Standard Deviation 6.0
|
16.0 Points on a scale (0-24)
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 14, and Week 26/Early WithdrawalPopulation: ITT Population
Health-related quality of life (HR-QoL) patient reported outcomes from the motivation and energy inventory-short form (MEI-SF) questionnaire. Scores could range from 0 (worst possible) to 72 (best possible).
Outcome measures
| Measure |
Placebo
n=62 Participants
Matching placebo tablets taken once a day
|
Eltrombopag 50 mg QD
n=135 Participants
Eltrombopag 50 mg oral tablets taken once a day (QD)
|
|---|---|---|
|
HR-QoL Instrument and Domain Scores From the MEI-SF Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
Baseline
|
71.3 Points on a scale (0-72)
Standard Deviation 17.2
|
72.7 Points on a scale (0-72)
Standard Deviation 21.4
|
|
HR-QoL Instrument and Domain Scores From the MEI-SF Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
Week 6
|
73.4 Points on a scale (0-72)
Standard Deviation 16.4
|
76.2 Points on a scale (0-72)
Standard Deviation 19.5
|
|
HR-QoL Instrument and Domain Scores From the MEI-SF Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
Week 14
|
71.1 Points on a scale (0-72)
Standard Deviation 20.5
|
76.9 Points on a scale (0-72)
Standard Deviation 20.5
|
|
HR-QoL Instrument and Domain Scores From the MEI-SF Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment
Week 26/Early Withdrawal
|
72.0 Points on a scale (0-72)
Standard Deviation 21.7
|
76.7 Points on a scale (0-72)
Standard Deviation 20.2
|
Adverse Events
Placebo
Serious events: 11 serious events
Other events: 56 other events
Deaths: 0 deaths
Eltrombopag 50 mg QD
Serious events: 16 serious events
Other events: 120 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=61 participants at risk
Matching placebo tablets taken once a day
|
Eltrombopag 50 mg QD
n=135 participants at risk
Eltrombopag 50 mg oral tablets taken once a day (QD)
|
|---|---|---|
|
Eye disorders
Cataract
|
3.3%
2/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
1.5%
2/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Eye disorders
Cataract subcapsular
|
1.6%
1/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.00%
0/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Eye disorders
Retinal haemorrhage
|
1.6%
1/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.00%
0/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Nervous system disorders
Headache
|
0.00%
0/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
2.2%
3/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Nervous system disorders
Brain stem haemorrhage
|
1.6%
1/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.00%
0/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.74%
1/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Investigations
Alanine aminotransferase (ALT) increased
|
1.6%
1/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.74%
1/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Investigations
Aspartate aminotransferase (AST) increased
|
0.00%
0/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.74%
1/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Investigations
Heart rate increased
|
1.6%
1/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.00%
0/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Investigations
Renal function test abnormal
|
1.6%
1/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.00%
0/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Investigations
Transaminases increased
|
0.00%
0/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.74%
1/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.74%
1/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.6%
1/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.00%
0/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.74%
1/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Infections and infestations
Cellulitis
|
1.6%
1/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.00%
0/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Infections and infestations
Orchitis
|
1.6%
1/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.00%
0/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.74%
1/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
1.5%
2/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.74%
1/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
1.6%
1/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.00%
0/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.74%
1/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.74%
1/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.74%
1/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.6%
1/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.00%
0/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.74%
1/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.6%
1/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.00%
0/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.74%
1/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
1.6%
1/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.00%
0/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Renal and urinary disorders
Urogenital haemorrhage
|
1.6%
1/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.00%
0/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.74%
1/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.74%
1/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.6%
1/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.00%
0/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
Other adverse events
| Measure |
Placebo
n=61 participants at risk
Matching placebo tablets taken once a day
|
Eltrombopag 50 mg QD
n=135 participants at risk
Eltrombopag 50 mg oral tablets taken once a day (QD)
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
19.7%
12/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
10.4%
14/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.5%
7/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
10.4%
14/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Infections and infestations
Urinary tract infection
|
6.6%
4/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
5.9%
8/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Infections and infestations
Influenza
|
4.9%
3/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
5.2%
7/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Infections and infestations
Pharyngitis
|
1.6%
1/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
6.7%
9/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Infections and infestations
Cellulitis
|
6.6%
4/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
0.74%
1/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Nervous system disorders
Headache
|
32.8%
20/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
29.6%
40/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Nervous system disorders
Dizziness
|
9.8%
6/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
3.7%
5/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.8%
6/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
12.6%
17/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Gastrointestinal disorders
Nausea
|
6.6%
4/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
12.6%
17/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.2%
5/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
5.2%
7/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Gastrointestinal disorders
Constipation
|
9.8%
6/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
4.4%
6/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
7.4%
10/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.2%
5/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
1.5%
2/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.8%
6/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
6.7%
9/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
3/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
6.7%
9/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
3/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
6.7%
9/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
2/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
5.9%
8/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.6%
4/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
1.5%
2/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Eye disorders
Conjunctival haemorrhage
|
4.9%
3/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
2.2%
3/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
General disorders
Fatigue
|
13.1%
8/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
9.6%
13/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
General disorders
Oedema peripheral
|
9.8%
6/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
1.5%
2/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.8%
6/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
3.7%
5/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
6.6%
4/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
1.5%
2/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.8%
6/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
5.2%
7/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.2%
5/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
5.2%
7/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.9%
3/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
6.7%
9/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Investigations
Alanine aminotransferase (ALT) increased
|
4.9%
3/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
6.7%
9/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Investigations
Aspartate aminotransferase (AST) increased
|
3.3%
2/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
5.2%
7/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
|
Psychiatric disorders
Insomnia
|
8.2%
5/61
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
2.2%
3/135
62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER