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Trial record 90 of 141 for:    MPL

A Longitudinal 2-year Bone Marrow Study of Eltrombopag in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

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ClinicalTrials.gov Identifier: NCT01098487
Recruitment Status : Completed
First Posted : April 2, 2010
Results First Posted : March 12, 2015
Last Update Posted : March 12, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Purpura, Thrombocytopaenic, Idiopathic
Intervention Drug: Eltrombopag olamine
Enrollment 167
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Eltrombopag
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 162
Completed 118
Not Completed 44
Reason Not Completed
Adverse Event             22
Lack of Efficacy             11
Withdrawal by Subject             7
Lost to Follow-up             3
Physician Decision             1
Arm/Group Title Eltrombopag
Hide Arm/Group Description 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 Number of Baseline Participants 162
Hide Baseline Analysis Population Description
All Treated Subjects (ATS) Population: all participants who received at least one dose of study medication excluding the 5 participants from Center 082877.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 162 participants
43.1  (16.31)
[1]
Measure Description: All Treated Subjects (ATS) Population: all participants who received at least one dose of study medication excluding the 5 participants from Center 082877.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants
Female
104
  64.2%
Male
58
  35.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 162 participants
Asian - Central/South Asian Heritage 47
Asian - East Asian Heritage 32
Asian - South East Asian Heritage 1
White - White/Caucasian/European Heritage 81
Missing 1
1.Primary Outcome
Title Number of Participants With Bone Marrow (BM) Fibers of MF Grade 0, 1, 2 and 3 on the European Consensus (EC) Scale at Baseline
Hide Description 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.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
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 Number of Participants Analyzed 159
Measure Type: Number
Unit of Measure: Participants
MF-0 150
MF-1 9
MF-2 0
MF-3 0
2.Primary Outcome
Title Number of Participants With a Positive or Negative Collagen Level at Baseline
Hide Description 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.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
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 Number of Participants Analyzed 159
Measure Type: Number
Unit of Measure: Participants
Negative 159
Positive 0
3.Primary Outcome
Title Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year
Hide Description 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.
Time Frame Baseline and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
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 Number of Participants Analyzed 127
Measure Type: Number
Unit of Measure: Participants
MF-0 to MF-0 82
MF-0 to MF-1 33
MF-0 to MF-2 2
MF-0 to MF-3 2
MF-1 to MF-0 3
MF-1 to MF-1 2
MF-1 to MF-2 1
MF-1 to MF-3 0
MF-2 to MF-0 0
MF-2 to MF-1 0
MF-2 to MF-2 0
MF-2 to MF-3 0
MF-3 to MF-0 0
MF-3 to MF-1 0
MF-3 to MF-2 0
MF-3 to MF-3 0
Missing to MF-0 2
Missing to MF-1 0
Missing to MF-2 0
Missing to MF-3 0
4.Primary Outcome
Title Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years
Hide Description 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.
Time Frame Baseline and 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
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 Number of Participants Analyzed 93
Measure Type: Number
Unit of Measure: Participants
MF-0 to MF-0 79
MF-0 to MF-1 9
MF-0 to MF-2 0
MF-0 to MF-3 0
MF-1 to MF-0 2
MF-1 to MF-1 1
MF-1 to MF-2 0
MF-1 to MF-3 0
MF-2 to MF-0 0
MF-2 to MF-1 0
MF-2 to MF-2 0
MF-2 to MF-3 0
MF-3 to MF-0 0
MF-3 to MF-1 0
MF-3 to MF-2 0
MF-3 to MF-3 0
Missing to MF-0 2
Missing to MF-1 0
Missing to MF-2 0
Missing to MF-3 0
5.Primary Outcome
Title Number of Participants With a Positive or Negative Collagen Level at 1 Year
Hide Description 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.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
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 Number of Participants Analyzed 127
Measure Type: Number
Unit of Measure: Participants
Negative to Negative 120
Negative to Positive 5
Positive to Negative 0
Positive to Positive 0
Missing to Negative 2
Missing to Positive 0
6.Primary Outcome
Title Number of Participants With a Positive or Negative Collagen Level at 2 Year
Hide Description 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.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
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 Number of Participants Analyzed 93
Measure Type: Number
Unit of Measure: Participants
Negative to Negative 90
Negative to Positive 1
Positive to Negative 0
Positive to Positive 0
Missing to Negative 2
Missing to Positive 0
7.Secondary Outcome
Title Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ATS Population
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
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 Number of Participants Analyzed 162
Measure Type: Number
Unit of Measure: Participants
Albumin, G0, n=162 151
Albumin, G1, n=162 5
Albumin, G2, n=162 6
Albumin, G3, n=162 0
Albumin, G4, n=162 0
ALP, G0, n=162 125
ALP, G1, n=162 35
ALP, G2, n=162 2
ALP, G3, n=162 0
ALP, G4, n=162 0
ALT, G0, n=162 109
ALT, G1, n=162 37
ALT, G2, n=162 8
ALT, G3, n=162 7
ALT, G4, n=162 1
AST, G0, n=162 99
AST, G1, n=162 48
AST, G2, n=162 8
AST, G3, n=162 5
AST, G4, n=162 2
Total bilirubin, G0, n=162 103
Total bilirubin, G1, n=162 40
Total bilirubin, G2, n=162 17
Total bilirubin, G3, n=162 2
Total bilirubin, G4, n=162 0
Calcium (hypercalcemia), G0, n=162 159
Calcium (hypercalcemia), G1, n=162 2
Calcium (hypercalcemia), G2, n=162 1
Calcium (hypercalcemia), G3, n=162 0
Calcium (hypercalcemia), G4, n=162 0
Calcium (hypocalcemia), G0, n=162 92
Calcium (hypocalcemia), G1, n=162 57
Calcium (hypocalcemia), G2, n=162 12
Calcium (hypocalcemia), G3, n=162 0
Calcium (hypocalcemia), G4, n=162 1
Potassium (hyperkalemia), G0, n=162 138
Potassium (hyperkalemia), G1, n=162 14
Potassium (hyperkalemia), G2, n=162 5
Potassium (hyperkalemia), G3, n=162 5
Potassium (hyperkalemia), G4, n=162 0
Potassium (hypokalemia), G0, n=162 123
Potassium (hypokalemia), G1, n=162 35
Potassium (hypokalemia), G2, n=162 0
Potassium (hypokalemia), G3, n=162 4
Potassium (hypokalemia), G4, n=162 0
Sodium (hypernatremia), G0, n=162 138
Sodium (hypernatremia), G1, n=162 20
Sodium (hypernatremia), G2, n=162 2
Sodium (hypernatremia), G3, n=162 2
Sodium (hypernatremia), G4, n=162 0
Sodium (hyponatremia), G0, n=162 137
Sodium (hyponatremia), G1, n=162 21
Sodium (hyponatremia), G2, n=162 0
Sodium (hyponatremia), G3, n=162 3
Sodium (hyponatremia), G4, n=162 1
Inorganic phosphorus, G0, n=162 100
Inorganic phosphorus, G1, n=162 0
Inorganic phosphorus, G2, n=162 52
Inorganic phosphorus, G3, n=162 10
Inorganic phosphorus, G4, n=162 0
Creatinine, G0, n=162 149
Creatinine, G1, n=162 8
Creatinine, G2, n=162 3
Creatinine, G3, n=162 0
Creatinine, G4, n=162 2
8.Secondary Outcome
Title Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ATS Population
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
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 Number of Participants Analyzed 162
Measure Type: Number
Unit of Measure: Participants
Hemoglobin (increased), G0, n=162 143
Hemoglobin (increased), G1, n=162 17
Hemoglobin (increased), G2, n=162 1
Hemoglobin (increased), G3, n=162 1
Hemoglobin (increased), G4, n=162 0
Hemoglobin (anemia), G0, n=162 55
Hemoglobin (anemia), G1, n=162 63
Hemoglobin (anemia), G2, n=162 31
Hemoglobin (anemia), G3, n=162 13
Hemoglobin (anemia), G4, n=162 0
Lymphocyte count (increased), G0, n=161 122
Lymphocyte count (increased), G1, n=161 0
Lymphocyte count (increased), G2, n=161 39
Lymphocyte count (increased), G3, n=161 0
Lymphocyte count (increased), G4, n=161 0
Lymphocyte count (decreased), G0, n=161 86
Lymphocyte count (decreased), G1, n=161 36
Lymphocyte count (decreased), G2, n=161 26
Lymphocyte count (decreased), G3, n=161 13
Lymphocyte count (decreased), G4, n=161 0
Total ANC, G0, n=161 140
Total ANC, G1, n=161 12
Total ANC, G2, n=161 3
Total ANC, G3, n=161 3
Total ANC, G4, n=161 3
Platelet count, G0, n=162 2
Platelet count, G1, n=162 8
Platelet count, G2, n=162 3
Platelet count, G3, n=162 26
Platelet count, G4, n=162 123
WBC, G0, n=162 135
WBC, G1, n=162 21
WBC, G2, n=162 3
WBC, G3, n=162 3
WBC, G4, n=162 0
9.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ATS Population
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
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 Number of Participants Analyzed 162
Measure Type: Number
Unit of Measure: Participants
Any AE, on-therapy + 1 day 141
Any SAE, on-therapy + 1 day 41
Any AE, >1 to 30 days post therapy 12
Any SAE, >1 to 30 days post therapy 5
Any AE, >30 days post therapy 9
Any SAE, >30 days post therapy 1
Time Frame 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).
Adverse Event Reporting Description 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.
 
Arm/Group Title Eltrombopag
Hide Arm/Group Description 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.
All-Cause Mortality
Eltrombopag
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Eltrombopag
Affected / at Risk (%)
Total   42/162 (25.93%) 
Blood and lymphatic system disorders   
Anaemia  2/162 (1.23%) 
Immune thrombocytopenic purpura  1/162 (0.62%) 
Thrombocytopenia  2/162 (1.23%) 
Ear and labyrinth disorders   
Vertigo  2/162 (1.23%) 
Endocrine disorders   
Adrenal insufficiency  1/162 (0.62%) 
Gastrointestinal disorders   
Abdominal pain upper  1/162 (0.62%) 
Diarrhoea  1/162 (0.62%) 
Gastritis  1/162 (0.62%) 
Gastrointestinal haemorrhage  3/162 (1.85%) 
Gingival bleeding  2/162 (1.23%) 
Mallory-Weiss syndrome  1/162 (0.62%) 
Nausea  2/162 (1.23%) 
Vomiting  2/162 (1.23%) 
General disorders   
Chest pain  1/162 (0.62%) 
Fatigue  2/162 (1.23%) 
Gait disturbance  1/162 (0.62%) 
Local swelling  1/162 (0.62%) 
Pyrexia  1/162 (0.62%) 
Hepatobiliary disorders   
Cholecystitis  1/162 (0.62%) 
Cholelithiasis  1/162 (0.62%) 
Infections and infestations   
Cholecystitis infective  1/162 (0.62%) 
Dengue fever  1/162 (0.62%) 
Fungal infection  1/162 (0.62%) 
Gallbladder empyema  1/162 (0.62%) 
Lower respiratory tract infection  1/162 (0.62%) 
Pharyngitis  1/162 (0.62%) 
Pneumonia  1/162 (0.62%) 
Rash pustular  1/162 (0.62%) 
Sialoadenitis  1/162 (0.62%) 
Tooth abscess  2/162 (1.23%) 
Upper respiratory tract infection  1/162 (0.62%) 
Injury, poisoning and procedural complications   
Joint dislocation  1/162 (0.62%) 
Procedural pain  1/162 (0.62%) 
Road traffic accident  2/162 (1.23%) 
Investigations   
Alanine aminotransferase increased  2/162 (1.23%) 
Aspartate aminotransferase increased  1/162 (0.62%) 
Blood bilirubin increased  2/162 (1.23%) 
Hepatic enzyme increased  2/162 (1.23%) 
Liver function test abnormal  1/162 (0.62%) 
Musculoskeletal and connective tissue disorders   
Back pain  1/162 (0.62%) 
Haemarthrosis  1/162 (0.62%) 
Musculoskeletal chest pain  1/162 (0.62%) 
Osteoarthritis  1/162 (0.62%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Salivary gland cancer  1/162 (0.62%) 
T-cell lymphoma  1/162 (0.62%) 
Nervous system disorders   
Cerebral haemorrhage  2/162 (1.23%) 
Cerebral venous thrombosis  1/162 (0.62%) 
Headache  1/162 (0.62%) 
Lethargy  2/162 (1.23%) 
Transient ischaemic attack  1/162 (0.62%) 
Transverse sinus thrombosis  1/162 (0.62%) 
Psychiatric disorders   
Depression  1/162 (0.62%) 
Psychosomatic disease  1/162 (0.62%) 
Reproductive system and breast disorders   
Menorrhagia  3/162 (1.85%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome  1/162 (0.62%) 
Chronic obstructive pulmonary disease  1/162 (0.62%) 
Epistaxis  1/162 (0.62%) 
Lung disorder  1/162 (0.62%) 
Pulmonary embolism  1/162 (0.62%) 
Vascular disorders   
Deep vein thrombosis  1/162 (0.62%) 
Haematoma  1/162 (0.62%) 
Haemorrhage  1/162 (0.62%) 
Thrombophlebitis  1/162 (0.62%) 
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Eltrombopag
Affected / at Risk (%)
Total   114/162 (70.37%) 
Blood and lymphatic system disorders   
Anaemia  11/162 (6.79%) 
Iron deficiency anaemia  9/162 (5.56%) 
Ear and labyrinth disorders   
Vertigo  12/162 (7.41%) 
Gastrointestinal disorders   
Abdominal pain  9/162 (5.56%) 
Abdominal pain upper  14/162 (8.64%) 
Diarrhoea  21/162 (12.96%) 
Dyspepsia  16/162 (9.88%) 
Gingival bleeding  16/162 (9.88%) 
Nausea  21/162 (12.96%) 
Vomiting  15/162 (9.26%) 
General disorders   
Asthenia  9/162 (5.56%) 
Fatigue  15/162 (9.26%) 
Influenza like illness  15/162 (9.26%) 
Pain  9/162 (5.56%) 
Pyrexia  18/162 (11.11%) 
Infections and infestations   
Nasopharyngitis  17/162 (10.49%) 
Upper respiratory tract infection  20/162 (12.35%) 
Viral infection  13/162 (8.02%) 
Injury, poisoning and procedural complications   
Contusion  11/162 (6.79%) 
Investigations   
Alanine aminotransferase increased  13/162 (8.02%) 
Aspartate aminotransferase increased  12/162 (7.41%) 
Metabolism and nutrition disorders   
Decreased appetite  9/162 (5.56%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  22/162 (13.58%) 
Back pain  17/162 (10.49%) 
Pain in extremity  14/162 (8.64%) 
Nervous system disorders   
Dizziness  10/162 (6.17%) 
Headache  30/162 (18.52%) 
Reproductive system and breast disorders   
Menorrhagia  10/162 (6.17%) 
Respiratory, thoracic and mediastinal disorders   
Cough  24/162 (14.81%) 
Epistaxis  15/162 (9.26%) 
Oropharyngeal pain  16/162 (9.88%) 
Skin and subcutaneous tissue disorders   
Petechiae  17/162 (10.49%) 
Pruritus  12/162 (7.41%) 
Purpura  10/162 (6.17%) 
Rash  9/162 (5.56%) 
Vascular disorders   
Haematoma  13/162 (8.02%) 
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01098487     History of Changes
Other Study ID Numbers: 112940
First Submitted: March 25, 2010
First Posted: April 2, 2010
Results First Submitted: January 5, 2015
Results First Posted: March 12, 2015
Last Update Posted: March 12, 2015