Trial Outcomes & Findings for Eltrombopag Phase III Study In Chinese Chronic ITP Patients (NCT NCT01762761)
NCT ID: NCT01762761
Last Updated: 2019-12-03
Results Overview
The number of participants (responders) with platelet count \>=50x10\^9/L after 6 weeks of Stage 1 were compared between treatments using a logistic regression model adjusted for use of primary immune thrombocytopenia (ITP) medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count \<=15×10\^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Primary Analysis Data Set: a participant who withdrawals from Stage 1 or is emergently unblinded was classified as a negative response from the time of withdrawal or unblinding date and for all subsequent visits. In the event of a participant dying, information for all subsequent assessments would be considered missing. All intermittent missing data (apart from withdrawals) will be treated as missing.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
155 participants
Primary outcome timeframe
From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1
Results posted on
2019-12-03
Participant Flow
This study includes three stages: 8-week double-blind stage (Stage 1), 24-week open-label stage (Stage 2) and prolonged open-label stage (Stage 3) with voluntary participation until eltrombopag became commercially available in China. Final Results for this study are presented in this report.
Participants diagnosed with primary immune thrombocytopenia (ITP) for at least 12 months prior to randomization, platelet count of \<30×10\^9/Liter (L) within 48 hours (hrs) prior to Day 1; no response or relapsed after splenectomy or if not splenectomised and either not responded to prior therapies or relapsed to prior therapy were enrolled.
Participant milestones
| Measure |
Placebo
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
Participants initially received eltrombopag 25 milligrams (mg) QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
104
|
|
Overall Study
COMPLETED
|
12
|
39
|
|
Overall Study
NOT COMPLETED
|
39
|
65
|
Reasons for withdrawal
| Measure |
Placebo
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
Participants initially received eltrombopag 25 milligrams (mg) QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
15
|
17
|
|
Overall Study
Lack of Efficacy
|
9
|
25
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Study closed/terminated
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
|
Overall Study
Physician Decision
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
7
|
8
|
Baseline Characteristics
Eltrombopag Phase III Study In Chinese Chronic ITP Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=51 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.3 Years
STANDARD_DEVIATION 12.83 • n=5 Participants
|
44.7 Years
STANDARD_DEVIATION 15.91 • n=7 Participants
|
43.6 Years
STANDARD_DEVIATION 15.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
51 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1Population: Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication and with at least one platelet count post-Baseline in Stage 1.
The number of participants (responders) with platelet count \>=50x10\^9/L after 6 weeks of Stage 1 were compared between treatments using a logistic regression model adjusted for use of primary immune thrombocytopenia (ITP) medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count \<=15×10\^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Primary Analysis Data Set: a participant who withdrawals from Stage 1 or is emergently unblinded was classified as a negative response from the time of withdrawal or unblinding date and for all subsequent visits. In the event of a participant dying, information for all subsequent assessments would be considered missing. All intermittent missing data (apart from withdrawals) will be treated as missing.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Number of Participants (Responders) Achieving a Platelet Count >=50×10^9/L After the First 6 Weeks of Stage 1
|
3 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1Population: ITT Population: all randomized participants who received at least one dose of study medication and with at least one platelet count post-Baseline in Stage 1.
The number of participants (responders) with platelet count \>=50×10\^9/L at least once during the first 6 weeks of Stage 1 were compared between treatments using a logistic regression model adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count \<=15×10\^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Number of Participants Achieving a Platelet Count >=50×10^9/L at Least Once During the First 6 Weeks of Stage 1
|
9 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: From the start of study treatment (Day 1) up to the end of Stage 3Population: ITT Population: was comprised of all rand. participats who received at least 1 dose of study medication \& with at least 1 platelet count post-baseline (BL) in stages 1, 2 \& 3. 1 part. did not have a BL platelet count as platelet count not collected on Day 1 or within 48 hours prior to the 1st dose of investig. product; this part. was not evaluable
The number of participants achieving a platelet count \>=30×10\^9/L and at least 2 times the Baseline platelet count at least once during the first 6 weeks of Stage 1 were analyzed. The Baseline platelet count is defined as the platelet count taken on Day 1 of the study or within 48 hours prior to the first dose of investigational product. Logistic regression analysis was adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count \<=15×10\^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=103 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Number of Participants Achieving a Platelet Count >=30×10^9/L and at Least 2 Times the Baseline Platelet Count at Least Once During the 6 Weeks of Stage 1, the Whole Stage 2 and the Whole Stage 3
Stage 1 (during the first 6 weeks)
|
18 Participants
|
84 Participants
|
|
Number of Participants Achieving a Platelet Count >=30×10^9/L and at Least 2 Times the Baseline Platelet Count at Least Once During the 6 Weeks of Stage 1, the Whole Stage 2 and the Whole Stage 3
Stage 2 (during 24 weeks)
|
45 Participants
|
81 Participants
|
|
Number of Participants Achieving a Platelet Count >=30×10^9/L and at Least 2 Times the Baseline Platelet Count at Least Once During the 6 Weeks of Stage 1, the Whole Stage 2 and the Whole Stage 3
Stage 3
|
36 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: From the start of study treatment (Day 1) up to the end of Stage 3Population: ITT Population: was comprised of all rand. participats who received at least 1 dose of study medication \& with at least 1 platelet count post-baseline (BL) in stages 1, 2 \& 3.
The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss. The WHO Bleeding Scale were dichotomized to indicate no bleeding vs bleeding, i.e. 0=grade 0 and 1=grades 1, 2, 3 or 4. Generalized linear mixed model was applied with a Logit canonical link function for repeated binary data, allowing for Baseline dichotomized WHO bleeding grade, use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count \<=15×10\^9/L (yes/no) and treatment as fixed effects, and the participant was treated as a random effect. Bleeding incidences were recorded at Screening, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6 for Stage 1, Baseline, Weeks 4, 8, 16, 20, 24 for Stage 2; Baseline, Weeks 25, 29, 73, 97, 121, 145, 169, 193, 217, 241, 265, 284 for Stage 3. Bleeding incidences at these time points are presented.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 1: Baseline
|
36 Participants
|
68 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 1: Week 1
|
30 Participants
|
43 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 1: Week 2
|
27 Participants
|
32 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 1: Week 3
|
26 Participants
|
29 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 1: Week 4
|
24 Participants
|
23 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 1: Week 5
|
19 Participants
|
24 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 1: Week 6
|
17 Participants
|
17 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 2: Baseline
|
22 Participants
|
64 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 2: Week 4
|
8 Participants
|
7 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 2: Week 8
|
6 Participants
|
12 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 2: Week 16
|
5 Participants
|
8 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 2: Week 20
|
3 Participants
|
1 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 2: Week 24
|
3 Participants
|
6 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Baseline
|
16 Participants
|
49 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 25
|
14 Participants
|
19 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 29
|
1 Participants
|
1 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 73
|
1 Participants
|
3 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 97
|
1 Participants
|
1 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 121
|
1 Participants
|
0 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 145
|
0 Participants
|
1 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 169
|
1 Participants
|
0 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 193
|
0 Participants
|
0 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 217
|
2 Participants
|
2 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 241
|
—
|
0 Participants
|
|
Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 265
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: From the start of study treatment (Day 1) up to the end of Stage 3Population: ITT Population: was comprised of all rand. participats who received at least 1 dose of study medication \& with at least 1 platelet count post-baseline (BL) in stages 1, 2 \& 3.
The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss. The WHO Bleeding Scale grades were dichotomized into the following categories: no clinically significant bleeding = Grade 0 to 1; clinically significant bleeding = Grade 2 to 4. Generalized linear mixed model with a Logit canonical link function for repeated binary data, allowing for Baseline dichotomized WHO bleeding grade, use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count \<=15×10\^9/L (yes/no) and treatment as fixed effects, and the participant was treated as a random effect.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 1: Baseline
|
5 Participants
|
14 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 1:Week 1
|
5 Participants
|
12 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 1: Week 2
|
4 Participants
|
13 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 1: Week 3
|
6 Participants
|
11 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 1: Week 4
|
5 Participants
|
7 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 1: Week 5
|
2 Participants
|
8 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 1: Week 6
|
4 Participants
|
6 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 2: Baseline
|
3 Participants
|
13 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 2: Week 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 2: Week 8
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 2: Week 16
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 2: Week 20
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 2: Week 24
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Baseline
|
1 Participants
|
9 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 25
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 29
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 73
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 97
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 121
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 145
|
—
|
0 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 169
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 193
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 217
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 241
|
—
|
0 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 265
|
—
|
0 Participants
|
|
Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale
Stage 3: Week 286
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1Population: ITT Population: was comprised of all randomized participants who received at least 1 dose of study medication \& with at least 1 platelet count post-baseline in Stage 1. Only those participants with a response were analyzed.
Time to response is defined as time from the startin of treatment to the first time of achieving a platelet count \>=50x10\^9/L during the first 6 weeks of Stage 1. Time to response is summarized using Kaplan-Meier estimates and compared between treatment groups using a stratified log-rank test, stratifying for the use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count \<=15x10\^9/L (yes/no). The pike estimator of the treatment hazard ratio is based on the stratified log-rank test. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Time to Response
|
NA Weeks
The analysis was limited to only par. with a response (3 responders out of the 50 par. in the placebo group). Due to low event incidence observed in placebo group, the median time and the CI could not be calculated from the Kaplan-Meier estimates.
|
3.14 Weeks
Interval 3.0 to 4.14
|
SECONDARY outcome
Timeframe: From the start of study treatment (Day 1) up to the end of Stage 3Population: ITT Population: was comprised of all rand. participats who received at least 1 dose of study medication \& with at least 1 platelet count post-baseline (BL) in stages 1, 2 \& 3.
Rescue treatment is defined as either a new ITP medication, an increase in dose of concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy. Logistic regression analysis was adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count \<=15x10\^9/L (yes/no) and treatment.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Number of Participants Who Required Protocol-defined Rescue Treatment During the First 6 Weeks of Stage 1, Whole Stages 2 & 3
Stage 1 (first 6 weeks)
|
17 Participants
|
9 Participants
|
|
Number of Participants Who Required Protocol-defined Rescue Treatment During the First 6 Weeks of Stage 1, Whole Stages 2 & 3
Stage 2
|
16 Participants
|
14 Participants
|
|
Number of Participants Who Required Protocol-defined Rescue Treatment During the First 6 Weeks of Stage 1, Whole Stages 2 & 3
Stage 3
|
13 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: From the start of study treatment (Day 1) up to the end of Stage 3Population: ITT Population: was comprised of all rand. participants who received at least 1 dose of study medication \& with at least 1 platelet count post-baseline (BL) in stages 1, 2 \& 3.
The number of participants with a platelet count \>=50×10\^9/L during at least 75% of their platelet count assessments was analyzed up to the end of Week 6 of Stage 1. Logistic regression analysis was adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count \<=15x10\^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Number of Participants With a Platelet Count >=50×10^9/L During at Least 75% of Their Platelet Count Assessments
Stage 1 (first 6 weeks)
|
1 Participants
|
23 Participants
|
|
Number of Participants With a Platelet Count >=50×10^9/L During at Least 75% of Their Platelet Count Assessments
Stage 2
|
10 Participants
|
38 Participants
|
|
Number of Participants With a Platelet Count >=50×10^9/L During at Least 75% of Their Platelet Count Assessments
Stage 3
|
13 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: From the start of study treatment (Day 1) up to the end of Stage 3Population: ITT Population: was comprised of all rand. participants who received at least 1 dose of study medication \& with at least 1 platelet count post-baseline (BL) in stages 1, 2 \& 3.
Total duration of time a participant had platelet count \>=50 x 10\^9/L was analyzed using the van Elteren stratified rank test with stratification factors including the use of ITP medication at Baseline (yes/no), splenectomy (yes/no) and Baseline platelet count \<=15x10\^9/L (yes/no). Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Total Duration of Time a Participant Had a Platelet Count >=50×10^9/L
Stage 1 (first 6 weeks)
|
0.00 Weeks
Interval 0.0 to 5.1
|
1.79 Weeks
Interval 0.14 to 5.1
|
|
Total Duration of Time a Participant Had a Platelet Count >=50×10^9/L
Stage 2
|
4.07 Weeks
Interval 0.0 to 23.3
|
7.29 Weeks
Interval 0.0 to 24.6
|
|
Total Duration of Time a Participant Had a Platelet Count >=50×10^9/L
Stage 3
|
27.00 Weeks
Interval 0.0 to 227.4
|
43.71 Weeks
Interval 0.0 to 224.0
|
SECONDARY outcome
Timeframe: From the start of study treatment (Day 1) up to the end of Stage 3Population: ITT Population: was comprised of all rand. participants who received at least 1 dose of study medication \& with at least 1 platelet count post-baseline (BL) in stages 1, 2 \& 3.
Maximum period of time a participant had a platelet count continously \>=50 x 10\^9/L was analyzed using the van Elteren stratified rank test with stratification factors including the use of ITP medication at Baseline (yes/no), splenectomy (yes/no) and Baseline platelet count \<=15x10\^9/L (yes/no). Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Maximum Period of Time a Participant Had a Platelet Count Continuously >= 50 ×10^9/L
Stage 1 (first 6 weeks)
|
0.00 Weeks
Interval 0.0 to 0.0
|
1.57 Weeks
Interval 0.14 to 3.07
|
|
Maximum Period of Time a Participant Had a Platelet Count Continuously >= 50 ×10^9/L
Stage 2
|
2.71 Weeks
Interval 0.0 to 23.3
|
5.00 Weeks
Interval 0.0 to 24.6
|
|
Maximum Period of Time a Participant Had a Platelet Count Continuously >= 50 ×10^9/L
Stage 3
|
16.43 Weeks
Interval 0.0 to 227.1
|
28.14 Weeks
Interval 0.0 to 227.1
|
SECONDARY outcome
Timeframe: From the start of Stage 2 to the end of Stage 3Population: ITT Population: was comprised of all rand. participants who received at least 1 dose of study medication \& with at least 1 platelet count post-baseline (BL) in stages 2 \& 3.
The number of participants taking concomitant ITP medications on Day 1 of Stage 1 who had a decrease in the dose or frequency of ITP medication or stopped ITP medication at any point during Stage 2 or Stage 3 will be presented. The Baseline concomitant ITP medication for Stage 2 and Stage 3 is defined as ITP medications taken prior to the first dose of investigational product of Stage 1. This study is still ongoing and this endpoint can only be analyzed when the stage 2 and stage 3 complete.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=100 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Number of Participants That Reduced or Discontinued Baseline Concomitant ITP Medications During Stage 2 and Stage 3
Stage 2
|
19 Participants
|
20 Participants
|
|
Number of Participants That Reduced or Discontinued Baseline Concomitant ITP Medications During Stage 2 and Stage 3
Stage 3
|
5 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: From the start of study treatment (Day 1) up to the end of Week 8 of Stage 1Population: Safety Population: all randomized participants who received at least one dose of the study treatment.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, is a congenital anomaly/birth defect or is associated with protocol specified liver injury and impaired liver function or is any protocol specific AEs.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Stage 1: Any AE
|
34 Participants
|
66 Participants
|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Stage 1: Any SAE
|
5 Participants
|
5 Participants
|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Stage 2: Any AE
|
43 Participants
|
64 Participants
|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Stage 2: Any SAE
|
6 Participants
|
11 Participants
|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Stage 3: any AE
|
38 Participants
|
70 Participants
|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Stage 3: Any SAE
|
11 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Clinical chemistry parameters aspartate amino transferase (AST), alanine amino transferase (ALT), gamma glutamyl transferase (GGT), total bilirubin, albumin, alkaline phosphatase, calcium, potassium, creatinine, glucose and sodium were evaluated at Baseline, at all on therapy visits, and at Week 1, Week 2, Week 3, and Week 4 visits during the follow-up period and were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (NCI CTCAE V4.0): Grade 0, none; Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant; Grade 4, life-threatening consequences; Grade 5, death related to AE. Day 1 assessment was considered as Baseline; if Day 1 was not available then Screening assessment is taken as Baseline. For creatinine, Baseline is defined as the average of Screening and Day 1 values if available and prior to first dose. Maximum post-Baseline toxicity grade included any scheduled or unscheduled post-Baseline assessment
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Albumin, Grade 1
|
2 Participants
|
10 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Albumin, Grade 2
|
1 Participants
|
2 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Albumin, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Albumin, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Albumin, Grade 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Alkaline Phosphatase, Grade 1
|
1 Participants
|
8 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Alkaline Phosphatase, Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Alkaline Phosphatase, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Alkaline Phosphatase, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Alkaline Phosphatase, Grade 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Calcium, Grade 1
|
4 Participants
|
16 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Calcium, Grade 2
|
5 Participants
|
13 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Calcium, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Calcium, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Calcium, Grade 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Potassium, Grade 1
|
25 Participants
|
25 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Potassium, Grade 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Potassium, Grade 3
|
1 Participants
|
7 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Potassium, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Potassium, Grade 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Creatinine, Grade 1
|
0 Participants
|
2 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Creatinine, Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Creatinine, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Creatinine, Grade 4
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Creatinine, Grade 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Glucose, Grade 1
|
14 Participants
|
34 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Glucose, Grade 2
|
4 Participants
|
13 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Glucose, Grade 3
|
2 Participants
|
2 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Glucose, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Glucose, Grade 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Sodium, Grade 1
|
10 Participants
|
19 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Sodium, Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Sodium, Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Sodium, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Sodium, Grade 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
AST, Grade 1
|
8 Participants
|
10 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
AST, Grade 2
|
0 Participants
|
2 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
AST, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
AST, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
AST, Grade 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
ALT, Grade 1
|
11 Participants
|
14 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
ALT, Grade 2
|
2 Participants
|
1 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
ALT, Grade 3
|
1 Participants
|
1 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
ALT, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
ALT, Grade 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
GGT,Grade 1
|
10 Participants
|
10 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
GGT,Grade 2
|
2 Participants
|
2 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
GGT,Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
GGT,Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
GGT,Grade 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Total Bilirubin, Grade 1
|
2 Participants
|
17 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Total Bilirubin, Grade 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Total Bilirubin, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Total Bilirubin, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Total Bilirubin, Grade 5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
Clinical hematology parameters hemoglobin, lymphocytes, platelet count, total neutrophils, white blood cell count evaluations were performed at Baseline, at all on-therapy visits, and at Week 1, Week 2, Week 3, and Week 4 visits during the follow-up period and were summarized according to the NCI CTCAE V4.0: Grade 0, none; Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant; Grade 4, life-threatening consequences; Grade 5, death related to AE. Day 1 assessment was considered as Baseline; if Day 1 was not available then Screening assessment is taken as Baseline. Maximum post-Baseline toxicity grade included any scheduled or unscheduled post-Baseline assessment.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Hemoglobin, Grade 1
|
21 Participants
|
35 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Hemoglobin, Grade 2
|
1 Participants
|
11 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Hemoglobin, Grade 3
|
3 Participants
|
4 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Hemoglobin, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Hemoglobin, Grade 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Lymphocytes, Grade 1
|
0 Participants
|
2 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Lymphocytes, Grade 2
|
12 Participants
|
16 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Lymphocytes, Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Lymphocytes, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Lymphocytes, Grade 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Platelet count, Grade 1
|
1 Participants
|
1 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Platelet count, Grade 2
|
0 Participants
|
11 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Platelet count, Grade 3
|
5 Participants
|
26 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Platelet count, Grade 4
|
44 Participants
|
66 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Platelet count, Grade 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Total Neutrophils, Grade 1
|
5 Participants
|
7 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Total Neutrophils, Grade 2
|
3 Participants
|
3 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Total Neutrophils, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Total Neutrophils, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
Total Neutrophils, Grade 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
White Blood Cell Count, Grade 1
|
4 Participants
|
9 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
White Blood Cell Count, Grade 2
|
1 Participants
|
2 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
White Blood Cell Count, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
White Blood Cell Count, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters
White Blood Cell Count, Grade 5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6Population: Safety Population
Systolic blood pressure was measured in the sitting position at Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure
Week 1
|
-0.3 Millimeters of mercury (mm Hg)
Standard Deviation 8.86
|
-0.7 Millimeters of mercury (mm Hg)
Standard Deviation 12.65
|
|
Change From Baseline in Systolic Blood Pressure
Week 2
|
-2.0 Millimeters of mercury (mm Hg)
Standard Deviation 9.83
|
-0.2 Millimeters of mercury (mm Hg)
Standard Deviation 14.08
|
|
Change From Baseline in Systolic Blood Pressure
Week 3
|
0.3 Millimeters of mercury (mm Hg)
Standard Deviation 12.61
|
-1.5 Millimeters of mercury (mm Hg)
Standard Deviation 14.05
|
|
Change From Baseline in Systolic Blood Pressure
Week 4
|
-0.2 Millimeters of mercury (mm Hg)
Standard Deviation 13.24
|
-2.7 Millimeters of mercury (mm Hg)
Standard Deviation 14.37
|
|
Change From Baseline in Systolic Blood Pressure
Week 5
|
-3.0 Millimeters of mercury (mm Hg)
Standard Deviation 12.02
|
-2.8 Millimeters of mercury (mm Hg)
Standard Deviation 12.57
|
|
Change From Baseline in Systolic Blood Pressure
Week 6
|
-1.5 Millimeters of mercury (mm Hg)
Standard Deviation 13.25
|
-2.3 Millimeters of mercury (mm Hg)
Standard Deviation 13.62
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6Population: Safety Population
Diastolic blood pressure was measured in sitting position at Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure
Week 1
|
-0.3 mm Hg
Standard Deviation 6.66
|
-0.5 mm Hg
Standard Deviation 8.90
|
|
Change From Baseline in Diastolic Blood Pressure
Week 2
|
-1.1 mm Hg
Standard Deviation 8.01
|
-0.1 mm Hg
Standard Deviation 10.91
|
|
Change From Baseline in Diastolic Blood Pressure
Week 3
|
-1.0 mm Hg
Standard Deviation 7.16
|
-1.5 mm Hg
Standard Deviation 10.40
|
|
Change From Baseline in Diastolic Blood Pressure
Week 4
|
-0.9 mm Hg
Standard Deviation 8.51
|
-1.4 mm Hg
Standard Deviation 9.57
|
|
Change From Baseline in Diastolic Blood Pressure
Week 5
|
-3.0 mm Hg
Standard Deviation 8.39
|
-1.8 mm Hg
Standard Deviation 9.78
|
|
Change From Baseline in Diastolic Blood Pressure
Week 6
|
-2.2 mm Hg
Standard Deviation 9.44
|
-1.0 mm Hg
Standard Deviation 9.71
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6Population: Safety Population
Pulse rate was measured at Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Change From Baseline in Pulse Rate
Week 5
|
0.0 Beats per minute
Standard Deviation 9.06
|
0.0 Beats per minute
Standard Deviation 7.32
|
|
Change From Baseline in Pulse Rate
Week 6
|
-2.1 Beats per minute
Standard Deviation 8.55
|
0.1 Beats per minute
Standard Deviation 8.06
|
|
Change From Baseline in Pulse Rate
Week 1
|
-0.5 Beats per minute
Standard Deviation 6.88
|
0.2 Beats per minute
Standard Deviation 8.54
|
|
Change From Baseline in Pulse Rate
Week 2
|
-2.2 Beats per minute
Standard Deviation 9.23
|
0.2 Beats per minute
Standard Deviation 9.54
|
|
Change From Baseline in Pulse Rate
Week 3
|
1.6 Beats per minute
Standard Deviation 10.31
|
0.2 Beats per minute
Standard Deviation 8.79
|
|
Change From Baseline in Pulse Rate
Week 4
|
-0.1 Beats per minute
Standard Deviation 7.32
|
0.8 Beats per minute
Standard Deviation 8.52
|
SECONDARY outcome
Timeframe: BaselinePopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
Resting 12-lead ECG was obtained at Baseline. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. ECG was also obtained when there was clinical symptom that potentially related to cardiac dysfunction based on investigator's judgement.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Finding at Baseline
Normal
|
36 Particpants
|
57 Particpants
|
|
Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Finding at Baseline
Abnormal, not clinically significant
|
14 Particpants
|
43 Particpants
|
|
Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Finding at Baseline
Abnormal, clinically significant
|
0 Particpants
|
4 Particpants
|
SECONDARY outcome
Timeframe: From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1Population: Safety Population
Visual acuity is a measure of the spatial resolution of the visual processing system. Acuity is a measure of visual performance and is unrelated to the eyeglass prescription required to correct vision. Normal visual acuity is commonly referred to as 20/20 vision. Evaluation was done for oculus sinister (OS) for the left eye, oculus dexter (OD) for the right eye. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Number of Participants With a Change From Baseline in Visual Acuity
OD
|
24 Participants
|
33 Participants
|
|
Number of Participants With a Change From Baseline in Visual Acuity
OS
|
22 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: ScreeningPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed.
Bone marrow biopsy was performed at Screening and then obtained when clinically indicated. Whenever a peripheral blood smear confirmed the presence of immature or dysplastic cells, a bone marrow examination was performed. Myelofibrosis (MF) was graded from Grade MF-0 to MF-3 where MF-0=scattered linear reticulin with no intersections (cross-overs) corresponding to normal bone marrow; MF-1=loose network of reticulin with many intersections; especially in perivascular areas; MF-2=diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3=diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=102 Participants
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Number of Participants With the Indicated Grading of Myelofibrosis Using Bone Marrow Biopsy at Screening
MF Score 0
|
38 Participants
|
83 Participants
|
|
Number of Participants With the Indicated Grading of Myelofibrosis Using Bone Marrow Biopsy at Screening
MF Score 1
|
13 Participants
|
19 Participants
|
|
Number of Participants With the Indicated Grading of Myelofibrosis Using Bone Marrow Biopsy at Screening
MF Score 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Grading of Myelofibrosis Using Bone Marrow Biopsy at Screening
MF Score 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2Population: PK Population: all participants with evaluable dosing, actual sampling time, and eltrombopag concentration data.
Vc/F is apparent volume of distribution of plasma (VDP) in central compartment and Vp/F is apparent VDP in peripheral compartment. PK assessments were made with one group of serial sampling \[Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose\] and one group of sparse assessment \[Samples collected at pre-dose, between 2 to 4 hr and 5 to 8 hr post-dose\]. Pre-dose samples were collected within 2 hr prior to dosing, all other samples were collected within 10 minutes(min) for samples collected between 1 and 6 hrs and within 30 mins for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameters are presented.
Outcome measures
| Measure |
Placebo
n=148 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Pharmacokinetic (PK) Assessments for Eltrombopag for Apparent Volume of Distribution of Central Compartment (Vc/F), Apparent Volume of Distribution of Peripheral Compartment (Vp/F)
Vc/F
|
8.80 Liters
Interval 7.84 to 9.76
|
—
|
|
Pharmacokinetic (PK) Assessments for Eltrombopag for Apparent Volume of Distribution of Central Compartment (Vc/F), Apparent Volume of Distribution of Peripheral Compartment (Vp/F)
Vp/F
|
33.6 Liters
Interval 17.0 to 50.2
|
—
|
SECONDARY outcome
Timeframe: From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2Population: PK Population
CL/F is defined as the apparent oral clearance from plasma and Q/F is defined as apparent intercompartmental clearance. PK assessments were made with one group of serial sampling \[Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose\] and one group of sparse assessment \[Samples collected at pre-dose, between 2 to 4 hr and 5 to 8 hr post-dose\]. Pre-dose samples were collected within 2 hr prior to dosing, all other samples were collected within 10 min for samples collected between 1 and 6 hr and within 30 min for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameters are presented.
Outcome measures
| Measure |
Placebo
n=148 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Pharmacokinetic Assessments for Eltrombopag for Apparent Clearance (CL/F), Apparent Inter-compartmental Clearance (Q/F)
CL/F
|
0.370 Liters per hour(L/hr)
Interval 0.336 to 0.404
|
—
|
|
Pharmacokinetic Assessments for Eltrombopag for Apparent Clearance (CL/F), Apparent Inter-compartmental Clearance (Q/F)
Q/F
|
0.561 Liters per hour(L/hr)
Interval 0.444 to 0.678
|
—
|
SECONDARY outcome
Timeframe: From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2Population: PK Population
Ka is defined as the absorption rate constant. PK assessments were made with one group of serial sampling \[Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose\] and one group of sparse assessment \[Samples collected at pre-dose, between 2 to 4 hr and 5 to 8 hr post-dose\]. Pre-dose samples were collected within 2 hrs prior to dosing, all other samples were collected within 10 min for samples collected between 1 and 6 hrs and within 30 mins for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameter is presented.
Outcome measures
| Measure |
Placebo
n=148 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Pharmacokinetic Assessments for Eltrombopag for Absorption Rate Constant (Ka)
|
1.58 Per hour (1/hr)
Interval 1.05 to 2.11
|
—
|
SECONDARY outcome
Timeframe: From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2Population: PK Population
Absorption lag time (ALAG) is defined as the time taken for a drug to appear in the systemic circulation following administration. PK assessments were made with one group of serial sampling \[Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose\] and one group of sparse assessment \[Samples collected at pre-dose, between 2 to 4 hrs and 5 to 8 hrs post-dose\]. Pre-dose samples were collected within 2 hrs prior to dosing, all other samples were collected within 10 min for samples collected between 1 and 6 hr and within 30 min for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameter is presented.
Outcome measures
| Measure |
Placebo
n=148 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Pharmacokinetic Assessments for Eltrombopag for Absorption Lag Time (ALAG)
|
0.855 Hour
Interval 0.816 to 0.894
|
—
|
SECONDARY outcome
Timeframe: From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2Population: PK Population
AUC\[0-tau\] is defined as area under the concentration-time curve over a dosing interval (24 hr) of Eltrombopag atsteady-state after 50 mg once daily dose of eltrombopag. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Post-hoc estimates of steady-state eltrombopag was determined based on the final PK model. Individual PK parameters were derived from the final PK model by an empirical Bayes estimation. Summary of steady-state AUC(0-tau) of eltrombopag is presented here.
Outcome measures
| Measure |
Placebo
n=148 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Post-hoc Estimates of Plasma Eltrombopag Area Under the Concentration-time Curve Over a Dosing Interval (AUC[0-tau]) After 50 mg Once Daily Dose of Eltrombopag
|
88.8 Microgram* hour per milliliter(μg.hr/mL)
Interval 78.0 to 101.0
|
—
|
SECONDARY outcome
Timeframe: From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2Population: PK Population
Cmax is defined as maximum observed concentration after 50 mg once daily dose of eltrombopag. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Post-hoc estimates of steady-state eltrombopag Cmax was determined based on the final PK model. Individual PK parameters were derived from the final PK model by an empirical Bayes estimation. Summary of steady-state Cmax of eltrombopag .is presented here.
Outcome measures
| Measure |
Placebo
n=148 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Post-hoc Estimates of Maximum Observed Concentration (Cmax) for Eltrombopag After 50 mg Once Daily Dose of Eltrombopag
|
6916 Nanogram/ Milliliter (ng/mL)
Interval 6205.0 to 7708.0
|
—
|
SECONDARY outcome
Timeframe: From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2Population: PK/PD Population: all participants with evaluable dosing, actual sampling time, and platelet count data.
Responders are participants whose SLOP estimates are larger than zero. The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment.
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Percentage of Participants Estimated as Responders to Eltrombopag by the Pharmacokinetic/ Pharmacodynamic Model
|
89 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2Population: PK/PD Population
The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment.
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Pharmacodynamic Parameter-Linear Proportionality Constant of Drug Effect (SLOP): the Proportional Increase of Platelet Production Rate With Each 1-μg/mL Increase in Eltrombopag Plasma Concentration
|
0.860 Milliliter/microgram
Interval 0.639 to 1.08
|
—
|
SECONDARY outcome
Timeframe: From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2Population: PK/PD Population
The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment. The estimate of KIN was fixed to 1.43x10\^9/L.hr.
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Pharmacodynamic Parameter- Production Rate of Platelet Precursors (KIN)
|
1.43 1 x 10^9/L.hr
|
—
|
SECONDARY outcome
Timeframe: From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2Population: PK/PD Population
The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment. The estimate of KOUT was fixed to 0.0253 /hr.
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Pharmacodynamic Parameter-Maturation Rate of Platelet Precursors (KOUT)
|
0.0253 1/ hr
|
—
|
Adverse Events
Placebo
Serious events: 17 serious events
Other events: 48 other events
Deaths: 3 deaths
Eltrombopag
Serious events: 33 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=51 participants at risk
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 participants at risk
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
HAEMORRHAGIC ANAEMIA
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
3.9%
2/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.9%
3/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIC PURPURA
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
3.9%
2/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Endocrine disorders
THYROIDITIS SUBACUTE
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
CATARACT
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.8%
4/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
CATARACT SUBCAPSULAR
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
LENTICULAR OPACITIES
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
RETINOPATHY
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
GASTRIC POLYPS
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
INTUSSUSCEPTION
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
DEATH
|
3.9%
2/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
GASTROENTERITIS
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
HERPES ZOSTER
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.9%
2/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
RECTAL ABSCESS
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
FRACTURED COCCYX
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
SOFT TISSUE INJURY
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
BILIRUBIN CONJUGATED INCREASED
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
HEPATIC ENZYME INCREASED
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
PLATELET COUNT DECREASED
|
7.8%
4/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
SJOGREN'S SYNDROME
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC LUPUS ERYTHEMATOSUS
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON ADENOMA
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SEMINOMA
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
BRAIN STEM HAEMORRHAGE
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.8%
4/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
CEREBROVASCULAR INSUFFICIENCY
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
NEURALGIA
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.9%
2/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
CALCULUS URINARY
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Reproductive system and breast disorders
GYNAECOMASTIA
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Reproductive system and breast disorders
OVARIAN CYST RUPTURED
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Surgical and medical procedures
ABORTION INDUCED
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
NECROSIS ISCHAEMIC
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
Other adverse events
| Measure |
Placebo
n=51 participants at risk
Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
Eltrombopag
n=104 participants at risk
Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10\^9/L and 250×10\^9/L for a period of 8 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
17.6%
9/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.3%
17/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
3.9%
2/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.7%
8/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
VISION BLURRED
|
5.9%
3/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
7/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
7/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
DIARRHOEA
|
15.7%
8/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.6%
11/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
7.8%
4/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
TOOTHACHE
|
2.0%
1/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
7/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
CHEST DISCOMFORT
|
5.9%
3/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.9%
2/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
FATIGUE
|
7.8%
4/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.8%
5/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
OEDEMA PERIPHERAL
|
7.8%
4/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.9%
3/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
PYREXIA
|
7.8%
4/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.9%
2/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
GINGIVITIS
|
3.9%
2/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
7/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
NASOPHARYNGITIS
|
41.2%
21/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
26.9%
28/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
PHARYNGITIS
|
9.8%
5/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.6%
10/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
25.5%
13/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
37.5%
39/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
URINARY TRACT INFECTION
|
25.5%
13/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.3%
19/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
37.3%
19/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
26/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
35.3%
18/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
21.2%
22/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
BILIRUBIN CONJUGATED INCREASED
|
7.8%
4/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.6%
11/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
17.6%
9/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.3%
19/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
BLOOD BILIRUBIN UNCONJUGATED INCREASED
|
19.6%
10/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
9.6%
10/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
BLOOD CREATININE INCREASED
|
7.8%
4/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.9%
2/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
3.9%
2/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.7%
9/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
BLOOD UREA INCREASED
|
3.9%
2/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.8%
6/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
15.7%
8/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.5%
12/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
5.9%
3/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.96%
1/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
5.9%
3/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
7/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
RETICULOCYTE COUNT INCREASED
|
5.9%
3/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.9%
2/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
5.9%
3/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.9%
3/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
11.8%
6/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.8%
5/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
5.9%
3/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.8%
4/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
7.8%
4/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.8%
4/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
27.5%
14/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
19.2%
20/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.8%
4/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.8%
6/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.9%
2/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.8%
6/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
3.9%
2/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
7/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
DIZZINESS
|
5.9%
3/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
7/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
HEADACHE
|
5.9%
3/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.7%
8/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
PROTEINURIA
|
5.9%
3/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.8%
4/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
3.9%
2/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
7/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
7.8%
4/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.8%
4/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
RASH
|
13.7%
7/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
7/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
HYPERTENSION
|
5.9%
3/51 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.8%
4/104 • Adverse Event (AE) timeframe: Adverse events were collected from study start (form first dose of study treatment) until end of study treatment plus 30 days post-treatment, up to a maximum duration of approx. 70 months.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER