Trial Outcomes & Findings for A Longitudinal 2-year Bone Marrow Study of Eltrombopag in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP) (NCT NCT01098487)
NCT ID: NCT01098487
Last Updated: 2015-03-12
Results Overview
The evaluation of fibrosis was performed using BM biopsies in which the amount of fibrosis was assessed by the EC Grading Scale. This method distinguishes four degrees of fibrosis (myelofibrosis \[MF\]-0 to MF-3). MF Grade (G) 0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF Grade 1 is loose network of reticulin with many intersections, especially in perivascular areas; MF Grade 2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF Grade 3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
167 participants
Primary outcome timeframe
Baseline
Results posted on
2015-03-12
Participant Flow
A total of 167 participants were enrolled and received at least one dose of study medication. The 5 enrolled participants from center 082877 were excluded from the analysis due to the following: serious good clinical practice (GCP) findings related to informed consent, source documents and investigator study oversight.
Participant milestones
| Measure |
Eltrombopag
Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response.
|
|---|---|
|
Overall Study
STARTED
|
162
|
|
Overall Study
COMPLETED
|
118
|
|
Overall Study
NOT COMPLETED
|
44
|
Reasons for withdrawal
| Measure |
Eltrombopag
Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response.
|
|---|---|
|
Overall Study
Adverse Event
|
22
|
|
Overall Study
Lack of Efficacy
|
11
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
A Longitudinal 2-year Bone Marrow Study of Eltrombopag in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Baseline characteristics by cohort
| Measure |
Eltrombopag
n=162 Participants
Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response.
|
|---|---|
|
Age, Continuous
|
43.1 Years
STANDARD_DEVIATION 16.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
81 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: All Treated Subjects (ATS) Population: all participants who received at least one dose of study medication excluding the 5 participants from Center 082877. Participants with bone marrow biopsy data available in the relevant time period were included.
The evaluation of fibrosis was performed using BM biopsies in which the amount of fibrosis was assessed by the EC Grading Scale. This method distinguishes four degrees of fibrosis (myelofibrosis \[MF\]-0 to MF-3). MF Grade (G) 0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF Grade 1 is loose network of reticulin with many intersections, especially in perivascular areas; MF Grade 2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF Grade 3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.
Outcome measures
| Measure |
Eltrombopag
n=159 Participants
Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response.
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|---|---|
|
Number of Participants With Bone Marrow (BM) Fibers of MF Grade 0, 1, 2 and 3 on the European Consensus (EC) Scale at Baseline
MF-0
|
150 Participants
|
|
Number of Participants With Bone Marrow (BM) Fibers of MF Grade 0, 1, 2 and 3 on the European Consensus (EC) Scale at Baseline
MF-1
|
9 Participants
|
|
Number of Participants With Bone Marrow (BM) Fibers of MF Grade 0, 1, 2 and 3 on the European Consensus (EC) Scale at Baseline
MF-2
|
0 Participants
|
|
Number of Participants With Bone Marrow (BM) Fibers of MF Grade 0, 1, 2 and 3 on the European Consensus (EC) Scale at Baseline
MF-3
|
0 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.
The number of participants with a positive or negative collagen level was analyzed. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.
Outcome measures
| Measure |
Eltrombopag
n=159 Participants
Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response.
|
|---|---|
|
Number of Participants With a Positive or Negative Collagen Level at Baseline
Negative
|
159 Participants
|
|
Number of Participants With a Positive or Negative Collagen Level at Baseline
Positive
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 yearPopulation: ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.
The change from baseline to on-treatment assessments of European Consensus (EC) scale was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. MF-0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF-1 is loose network of reticulin with many intersections, especially in perivascular areas; MF-2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.
Outcome measures
| Measure |
Eltrombopag
n=127 Participants
Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response.
|
|---|---|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
Missing to MF-0
|
2 Participants
|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
Missing to MF-3
|
0 Participants
|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
MF-0 to MF-0
|
82 Participants
|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
MF-0 to MF-1
|
33 Participants
|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
MF-0 to MF-2
|
2 Participants
|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
MF-0 to MF-3
|
2 Participants
|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
MF-1 to MF-0
|
3 Participants
|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
MF-1 to MF-1
|
2 Participants
|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
MF-1 to MF-2
|
1 Participants
|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
MF-1 to MF-3
|
0 Participants
|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
MF-2 to MF-0
|
0 Participants
|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
MF-2 to MF-1
|
0 Participants
|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
MF-2 to MF-2
|
0 Participants
|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
MF-2 to MF-3
|
0 Participants
|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
MF-3 to MF-0
|
0 Participants
|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
MF-3 to MF-1
|
0 Participants
|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
MF-3 to MF-2
|
0 Participants
|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
MF-3 to MF-3
|
0 Participants
|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
Missing to MF-1
|
0 Participants
|
|
Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
Missing to MF-2
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2 yearsPopulation: ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.
The change from baseline to on-treatment assessments of European Consensus (EC) scale was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. MF-0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF-1 is loose network of reticulin with many intersections, especially in perivascular areas; MF-2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.
Outcome measures
| Measure |
Eltrombopag
n=93 Participants
Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response.
|
|---|---|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
MF-0 to MF-0
|
79 Participants
|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
MF-0 to MF-1
|
9 Participants
|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
MF-0 to MF-2
|
0 Participants
|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
MF-0 to MF-3
|
0 Participants
|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
MF-1 to MF-3
|
0 Participants
|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
MF-2 to MF-0
|
0 Participants
|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
MF-2 to MF-1
|
0 Participants
|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
MF-2 to MF-2
|
0 Participants
|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
MF-2 to MF-3
|
0 Participants
|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
MF-3 to MF-0
|
0 Participants
|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
MF-3 to MF-1
|
0 Participants
|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
MF-3 to MF-2
|
0 Participants
|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
MF-3 to MF-3
|
0 Participants
|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
Missing to MF-0
|
2 Participants
|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
Missing to MF-1
|
0 Participants
|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
Missing to MF-2
|
0 Participants
|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
Missing to MF-3
|
0 Participants
|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
MF-1 to MF-0
|
2 Participants
|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
MF-1 to MF-1
|
1 Participants
|
|
Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
MF-1 to MF-2
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.
The change from Baseline to on-treatment assessments of collagen level was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period.
Outcome measures
| Measure |
Eltrombopag
n=127 Participants
Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response.
|
|---|---|
|
Number of Participants With a Positive or Negative Collagen Level at 1 Year
Negative to Negative
|
120 Participants
|
|
Number of Participants With a Positive or Negative Collagen Level at 1 Year
Negative to Positive
|
5 Participants
|
|
Number of Participants With a Positive or Negative Collagen Level at 1 Year
Positive to Negative
|
0 Participants
|
|
Number of Participants With a Positive or Negative Collagen Level at 1 Year
Positive to Positive
|
0 Participants
|
|
Number of Participants With a Positive or Negative Collagen Level at 1 Year
Missing to Negative
|
2 Participants
|
|
Number of Participants With a Positive or Negative Collagen Level at 1 Year
Missing to Positive
|
0 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.
The change from Baseline to on-treatment assessments of collagen level was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period.
Outcome measures
| Measure |
Eltrombopag
n=93 Participants
Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response.
|
|---|---|
|
Number of Participants With a Positive or Negative Collagen Level at 2 Year
Positive to Positive
|
0 Participants
|
|
Number of Participants With a Positive or Negative Collagen Level at 2 Year
Negative to Negative
|
90 Participants
|
|
Number of Participants With a Positive or Negative Collagen Level at 2 Year
Negative to Positive
|
1 Participants
|
|
Number of Participants With a Positive or Negative Collagen Level at 2 Year
Positive to Negative
|
0 Participants
|
|
Number of Participants With a Positive or Negative Collagen Level at 2 Year
Missing to Negative
|
2 Participants
|
|
Number of Participants With a Positive or Negative Collagen Level at 2 Year
Missing to Positive
|
0 Participants
|
SECONDARY outcome
Timeframe: From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)Population: ATS Population
Clinical chemistry parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), sodium (hyponatremia), inorganic phosphorus and creatinine. Baseline values were obtained at Day 1. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during.
Outcome measures
| Measure |
Eltrombopag
n=162 Participants
Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response.
|
|---|---|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Albumin, G0, n=162
|
151 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Albumin, G1, n=162
|
5 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Albumin, G2, n=162
|
6 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Albumin, G3, n=162
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
ALP, G0, n=162
|
125 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
ALP, G1, n=162
|
35 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
ALP, G2, n=162
|
2 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
ALP, G3, n=162
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
ALP, G4, n=162
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
ALT, G0, n=162
|
109 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
ALT, G1, n=162
|
37 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
ALT, G2, n=162
|
8 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
ALT, G3, n=162
|
7 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
ALT, G4, n=162
|
1 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
AST, G0, n=162
|
99 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
AST, G1, n=162
|
48 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
AST, G3, n=162
|
5 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
AST, G4, n=162
|
2 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Total bilirubin, G0, n=162
|
103 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Total bilirubin, G1, n=162
|
40 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Total bilirubin, G4, n=162
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Calcium (hypercalcemia), G0, n=162
|
159 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Calcium (hypercalcemia), G1, n=162
|
2 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Calcium (hypercalcemia), G2, n=162
|
1 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Calcium (hypercalcemia), G3, n=162
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Calcium (hypercalcemia), G4, n=162
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Calcium (hypocalcemia), G1, n=162
|
57 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Calcium (hypocalcemia), G2, n=162
|
12 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Potassium (hyperkalemia), G0, n=162
|
138 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Potassium (hyperkalemia), G1, n=162
|
14 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Potassium (hyperkalemia), G3, n=162
|
5 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Potassium (hyperkalemia), G4, n=162
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Potassium (hypokalemia), G0, n=162
|
123 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Potassium (hypokalemia), G1, n=162
|
35 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Potassium (hypokalemia), G2, n=162
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Potassium (hypokalemia), G3, n=162
|
4 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Potassium (hypokalemia), G4, n=162
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Sodium (hypernatremia), G1, n=162
|
20 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Sodium (hypernatremia), G2, n=162
|
2 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Sodium (hypernatremia), G3, n=162
|
2 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Sodium (hypernatremia), G4, n=162
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Sodium (hyponatremia), G0, n=162
|
137 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Sodium (hyponatremia), G1, n=162
|
21 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Sodium (hyponatremia), G3, n=162
|
3 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Sodium (hyponatremia), G4, n=162
|
1 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Inorganic phosphorus, G0, n=162
|
100 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Inorganic phosphorus, G1, n=162
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Inorganic phosphorus, G2, n=162
|
52 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Inorganic phosphorus, G3, n=162
|
10 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Creatinine, G0, n=162
|
149 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Creatinine, G1, n=162
|
8 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Creatinine, G2, n=162
|
3 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Calcium (hypocalcemia), G0, n=162
|
92 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Calcium (hypocalcemia), G3, n=162
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Calcium (hypocalcemia), G4, n=162
|
1 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Potassium (hyperkalemia), G2, n=162
|
5 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Albumin, G4, n=162
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Sodium (hypernatremia), G0, n=162
|
138 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
AST, G2, n=162
|
8 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Total bilirubin, G2, n=162
|
17 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Total bilirubin, G3, n=162
|
2 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Sodium (hyponatremia), G2, n=162
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Inorganic phosphorus, G4, n=162
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Creatinine, G3, n=162
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Creatinine, G4, n=162
|
2 Participants
|
SECONDARY outcome
Timeframe: From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)Population: ATS Population
Hematology parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: hemoglobin (increased), hemoglobin (anemia), lymphocyte count (increased), lymphocyte count (decreased), total absolute neutrophil count (ANC), platelet count and white blood cell (WBC) count. Baseline values were obtained at Day 1. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during.
Outcome measures
| Measure |
Eltrombopag
n=162 Participants
Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response.
|
|---|---|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Hemoglobin (increased), G1, n=162
|
17 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Hemoglobin (increased), G2, n=162
|
1 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Hemoglobin (increased), G3, n=162
|
1 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Hemoglobin (increased), G4, n=162
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Hemoglobin (anemia), G0, n=162
|
55 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
WBC, G1, n=162
|
21 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Hemoglobin (increased), G0, n=162
|
143 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Hemoglobin (anemia), G1, n=162
|
63 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Hemoglobin (anemia), G2, n=162
|
31 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Hemoglobin (anemia), G3, n=162
|
13 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Hemoglobin (anemia), G4, n=162
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Lymphocyte count (increased), G0, n=161
|
122 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Lymphocyte count (increased), G1, n=161
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Lymphocyte count (increased), G2, n=161
|
39 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Lymphocyte count (increased), G3, n=161
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Lymphocyte count (increased), G4, n=161
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Lymphocyte count (decreased), G0, n=161
|
86 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Lymphocyte count (decreased), G1, n=161
|
36 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Lymphocyte count (decreased), G2, n=161
|
26 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Lymphocyte count (decreased), G3, n=161
|
13 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Lymphocyte count (decreased), G4, n=161
|
0 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Total ANC, G0, n=161
|
140 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Total ANC, G1, n=161
|
12 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Total ANC, G2, n=161
|
3 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Total ANC, G3, n=161
|
3 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Total ANC, G4, n=161
|
3 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Platelet count, G0, n=162
|
2 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Platelet count, G1, n=162
|
8 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Platelet count, G2, n=162
|
3 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Platelet count, G3, n=162
|
26 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Platelet count, G4, n=162
|
123 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
WBC, G0, n=162
|
135 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
WBC, G2, n=162
|
3 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
WBC, G3, n=162
|
3 Participants
|
|
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
WBC, G4, n=162
|
0 Participants
|
SECONDARY outcome
Timeframe: From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)Population: ATS Population
On-therapy + 1 day is defined as AEs started between the first dose of eltrombopag and up to the day after the last dose of eltrombopag; \>1 to 30 days post therapy is defined as AEs that started more than 1 day and up to 30 days after the last dose of eltrombopag; \>30 days post therapy is defined as AEs started that started more than 30 days after the last dose of eltrombopag. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.
Outcome measures
| Measure |
Eltrombopag
n=162 Participants
Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response.
|
|---|---|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy
Any AE, on-therapy + 1 day
|
141 Participants
|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy
Any SAE, on-therapy + 1 day
|
41 Participants
|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy
Any AE, >1 to 30 days post therapy
|
12 Participants
|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy
Any SAE, >1 to 30 days post therapy
|
5 Participants
|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy
Any AE, >30 days post therapy
|
9 Participants
|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy
Any SAE, >30 days post therapy
|
1 Participants
|
Adverse Events
Eltrombopag
Serious events: 42 serious events
Other events: 114 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eltrombopag
n=162 participants at risk
Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
2/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
2/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
1.2%
2/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.9%
3/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gingival bleeding
|
1.2%
2/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
2/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
2/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
General disorders
Chest pain
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
General disorders
Fatigue
|
1.2%
2/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
General disorders
Gait disturbance
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
General disorders
Local swelling
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Infections and infestations
Cholecystitis infective
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Infections and infestations
Dengue fever
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Infections and infestations
Fungal infection
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Infections and infestations
Gallbladder empyema
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Infections and infestations
Rash pustular
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Infections and infestations
Sialoadenitis
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Infections and infestations
Tooth abscess
|
1.2%
2/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.2%
2/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
2/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Investigations
Blood bilirubin increased
|
1.2%
2/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Investigations
Hepatic enzyme increased
|
1.2%
2/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Investigations
Liver function test abnormal
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.2%
2/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Nervous system disorders
Cerebral venous thrombosis
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Nervous system disorders
Lethargy
|
1.2%
2/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Nervous system disorders
Transverse sinus thrombosis
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Psychiatric disorders
Depression
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Psychiatric disorders
Psychosomatic disease
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.9%
3/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Vascular disorders
Haematoma
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Vascular disorders
Haemorrhage
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Vascular disorders
Thrombophlebitis
|
0.62%
1/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
Other adverse events
| Measure |
Eltrombopag
n=162 participants at risk
Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant's individual platelet count response.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.8%
11/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
5.6%
9/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
7.4%
12/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
9/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.6%
14/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.0%
21/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.9%
16/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gingival bleeding
|
9.9%
16/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
13.0%
21/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
9.3%
15/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
General disorders
Asthenia
|
5.6%
9/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
General disorders
Fatigue
|
9.3%
15/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
General disorders
Influenza like illness
|
9.3%
15/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
General disorders
Pain
|
5.6%
9/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
11.1%
18/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
10.5%
17/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.3%
20/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Infections and infestations
Viral infection
|
8.0%
13/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.8%
11/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
8.0%
13/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
7.4%
12/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
9/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.6%
22/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
17/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.6%
14/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
6.2%
10/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
18.5%
30/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Menorrhagia
|
6.2%
10/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.8%
24/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.3%
15/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.9%
16/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
10.5%
17/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
12/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
6.2%
10/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
9/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
|
Vascular disorders
Haematoma
|
8.0%
13/162 • On-treatment SAEs and non-serious AEs are defined as events occuring from the start of the treatment (Day 1) up to Week 104 and including the follow-up period of up to 6 months (only 4 weeks for most participants) (up to approximately 2.5 years).
SAEs and non-serious AEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER