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EXTEND (Eltrombopag Extended Dosing Study) (EXTEND)

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ClinicalTrials.gov Identifier: NCT00351468
Recruitment Status : Completed
First Posted : July 12, 2006
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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 (SB-497115-GR)
Enrollment 302
Recruitment Details Subjects were previously enrolled in a study of eltrombopag: TRA100773A, TRA100773B, TRA102537/RAISE, or TRA108057/REPEAT. Eligibility of consenting subjects was assessed during the screening period of up to 28 days prior to Day 1 of treatment.
Pre-assignment Details  
Arm/Group Title Eltrombopag
Hide Arm/Group Description Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
Period Title: Overall Study
Started 302
Subjects From TRA100773A 51
Subjects From TRA100773B 61
Subjects From TRA102537 Raise 146
Subjects From TRA108057 Repeat 43
Unknown - Not From Previous Trial 1 [1]
Completed 135
Not Completed 167
Reason Not Completed
Adverse Event             42
Withdrawal by Subject             39
Various -follow up w clinical team             39
Lack of Efficacy             32
Non-compliance             8
Lost to Follow-up             4
Protocol Violation             3
[1]
Mistakenly enrolled (not in any of the 3 trials) On 50 mg/d eltrombopag for 18 days and withdrawn
Arm/Group Title Eltrombopag
Hide Arm/Group Description Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
Overall Number of Baseline Participants 302
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 302 participants
48.9  (15.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants
Female
201
  66.6%
Male
101
  33.4%
Concomitant ITP Medication at Baseline  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 302 participants
Yes 101
No 201
Splenectomy Status at Baseline  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 302 participants
Yes 115
No 187
Baseline Platelet Count  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 302 participants
<30 Gi/L 211
30 - 50 Gi/L 52
> 50 Gi/L 39
1.Primary Outcome
Title Overall Summary of On-Therapy Adverse Events (Safety Population)
Hide Description All safety evaluation findings considered to be adverse events are reported in the Adverse Event section.
Time Frame Start date was the first dose of investigational product and up to the day after the last dose . Post-therapy: start date was more than 1 day after the last dose and up to 30 days after last dose of investigational product up to week 364
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
Overall Number of Participants Analyzed 302
Measure Type: Number
Unit of Measure: Participants
Any adverse event 277
Any serious adverse event 96
Adverse events related to study medication 133
Adverse events leading to withdrawal 41
Serious adverse events leading withdrawal 28
2.Secondary Outcome
Title Subjects Achieving Maximum Platelet Counts Greater Than or Equal to 30 Gi/L or 50 Gi/L in the Absence of Rescue Medication
Hide Description

Subjects who achieved maximum platelet count at least once during treatment. All platelet counts after an on-study splenectomy are not classed as responses.

Platelet counts within 7 days after a platelet transfusion are not classed as responses.

Platelet counts while taking an increased ITP medication or within 6 weeks after the end of an increased ITP medication are not classed as responses.

Time Frame Baseline up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
Overall Number of Participants Analyzed 302
Measure Type: Number
Unit of Measure: Participants
Baseline Platelet counts >= 30 Gi/L, 91
Baseline Platelet counts >= 50 Gi/L, 42
Maximum Platelet Count >= 30 Gi/L 276
Maximum Platelet Count >= 50 Gi/L 259
3.Secondary Outcome
Title Summary of Subjects Achieving Platelet Count Levels by Week, in the Absence of Rescue Medication
Hide Description

If a subject has more than 1 platelet count result within a week, the lowest value observed is used to determine response. All platelet counts after an on-study splenectomy are not classed as responses. Platelet counts within 7 days after a platelet transfusion are not classed as responses.

Platelet counts while taking an increased ITP medication or within 6 weeks after the end of an increased ITP medication are not classed as responses.

Time Frame Baseline up to Year 7/Week 364
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
Overall Number of Participants Analyzed 302
Measure Type: Number
Unit of Measure: Participants
Baseline Platelet counts >= 30 Gi/L, n=302 91
Baseline Platelet counts >= 50 Gi/L, n=302 42
Week 1 Platelet Count >= 30 Gi/L n=293 172
Week 1 Platelet Count >= 50 Gi/L n=293 127
Week 2 Platelet Count >= 30 Gi/L n=288 199
Week 2 Platelet Count >= 50 Gi/L n=288 165
Week 3 Platelet Count >= 30 Gi/L n=275 192
Week 3 Platelet Count >= 50 Gi/L n=275 159
Week 4 Platelet Count >= 30 Gi/L n=275 192
Week 4 Platelet Count >= 50 Gi/L n=275 149
Week 5 Platelet Count >= 30 Gi/L n=274 197
Week 5 Platelet Count >= 50 Gi/L n=274 159
Week 6 Platelet Count >= 30 Gi/L n=276 203
Week 6 Platelet Count >= 50 Gi/L n=276 169
Week 12 Platelet Count >= 30 Gi/L n=197 147
Week 12 Platelet Count >= 50 Gi/L n=197 120
Month 6/Week 26 Platelet Count >= 30 Gi/L n=130 93
Month 6/Week 26 Platelet Count >= 50 Gi/L n=130 82
Year 1/Week 52 Platelet Count >= 30 Gi/L n=83 62
Year 1/Week 52 Platelet Count >= 50 Gi/L n=83 50
Year 1.5/Week 78 Platelet Count >= 30 Gi/L n=63 47
Year 1.5/Week78 Platelet Count >= 50 Gi/L n=63 41
Year 2/Week 104 Platelet Count >= 30 Gi/L n=59 46
Year 2/Week 104 Platelet Count >= 50 Gi/L n=59 42
Year 2.5/Week 130 Platelet Count >= 30 Gi/L n=42 32
Year 2.5/Week 130 Platelet Count >= 50 Gi/L n=42 28
Year 3/Week 156 Platelet Count >= 30 Gi/L n=27 22
Year 3/Week 156 Platelet Count >= 50 Gi/L n=27 19
Year 3.5/Week 182 Platelet Count >= 30 Gi/L n=23 19
Year 3.5/Week 182 Platelet Count >= 50 Gi/L n=23 17
Year 4/Week 208 Platelet Count >= 30 Gi/L n=17 12
Year 4/Week 208 Platelet Count >= 50 Gi/L n=17 11
Year 4.5/Week 234 Platelet Count >= 30 Gi/L n=15 13
Year 4.5/Week 234 Platelet Count >= 50 Gi/L n=15 12
Year 5/Week 260 Platelet Count >= 30 Gi/L n=9 6
Year 5/Week 260 Platelet Count >= 50 Gi/L n=9 6
Year 5.5/Week 286 Platelet Count >= 30 Gi/L n=9 7
Year 5.5/Week 286 Platelet Count >= 50 Gi/L n=9 7
Year 6/Week 312 Platelet Count >= 30 Gi/L n=9 7
Year 6/Week 312 Platelet Count >= 50 Gi/L n=9 7
Year 6.5/Week 338 Platelet Count >= 30 Gi/L n=5 3
Year 6.5/Week 338 Platelet Count >= 50 Gi/L n=5 3
Year 7/Week 364 Platelet Count >= 30 Gi/L n=3 3
Year 7/Week 364 Platelet Count >= 50 Gi/L n=3 3
4.Secondary Outcome
Title Number of Subjects Who Responded to Eltrombopag in a Previous Study and Who Respond to Retreatment With a Rise in Platelet Count to Either ≥ 50,000/µL or ≥30,000/µL
Hide Description Responder in TRA100773: Platelet count 50 Gi/L and 2 x baseline (BL) at last on-treatment assessment. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline (BL), 50 Gi/L, and 30 Gi/L at any time. Responder in RAISE: Platelet count 50GI/L and 2 x baseline at Week 6 assessment. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline, 50 Gi/L, and 30 Gi/L at any time. Responder in REPEAT: Platelet count 50 GI/L and 2 x baseline (BL) at Week 6 assessment in Cycle 1. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline (BL) 50 Gi/L, and 30 Gi/L at any time.
Time Frame Baseline up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
Overall Number of Participants Analyzed 302
Measure Type: Number
Unit of Measure: Participants
TRA100773 Responders >= 50 Gi/L in EXTEND, n=51 49
TRA100773 >=50 Gi/L and 2 x BL in EXTEND, n=51 47
TRA100773 Responders >= 30 Gi/L in EXTEND, n=51 49
RAISE Responders >= 50 Gi/L in EXTEND, n=59 54
RAISE >= 50 Gi/L and 2 x BL in EXTEND, n=59 53
RAISE Responders >= 30 Gi/L in EXTEND, n=51 55
REPEAT Responders >= 50 Gi/L in EXTEND, n=36 33
REPEAT>= 50 Gi/L and 2 x BL in EXTEND, n=36 33
REPEAT Responders >= 30 Gi/L in EXTEND, n=36 35
5.Secondary Outcome
Title Number of Participants With Reduction and/or Sparing of Concomitant ITP Therapies, While Maintaining a Platelet Count ≥ 50,000/mL.
Hide Description Sustain reduct: Sustained reduction 1 Denominator is number of subjects taking an ITP medication at baseline. 2 Denominator is number of subjects with a sustained reduction. Note: Sustained reduction defined as reduction from baseline in dose and/or frequency which is maintained for at least 4 weeks. Excludes sustained reductions started more than 1 day after last dose.
Time Frame Baseline up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
Overall Number of Participants Analyzed 302
Measure Type: Number
Unit of Measure: Participants
ITP medication at baseline 101
Sustain reduct or stop at least 1 med [1] n=101 71
Permanently stopping at least 1 ITP med [1] n=101 53
Sustained reduction[1] n=101 70
Maximum sustained reduction ≥ 24 weeks[2] n=70 66
6.Secondary Outcome
Title Number of Subjects Who Required Rescue Therapy During Treatment With Eltrombopag.
Hide Description Rescue treatment is defined as a composite of: new ITP medication, increased dose of a concomitant ITP medication, platelet transfusion, and splenectomy. Subjects may have received more than 1 type of rescue therapy
Time Frame Baseline up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
Overall Number of Participants Analyzed 302
Measure Type: Number
Unit of Measure: Participants
New ITP medication, n=103 82
Increase in dose of ITP med from baseline, n=103 27
Platelet transfusion, n=103 21
Splenectomy, n=103 3
7.Secondary Outcome
Title Maximum ITP Bleeding Score at Any Time During the Study During All Stages.
Hide Description The ITP bleeding score is a tool which has been designed specifically to assess the bruising and bleeding in patients with ITP across body sites, ranging from mild to severe. The WHO Grades were dichotomized into the following categories: - Grade 0, No bleeding -Grade 1 to 4, Any bleeding -Grade 0 to 1: No clinically significant bleeding -Grade 2 to 4 Clinically significant bleeding
Time Frame Baseline up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
Overall Number of Participants Analyzed 302
Measure Type: Number
Unit of Measure: Participants
Epistaxis n=300 Grade 0 204
Epistaxis n=300 Grade 1 65
Epistaxis n=300 Grade 2 31
Gastrointestinal n=300 Grade 0 264
Gastrointestinal n=300 Grade 1 26
Gastrointestinal n=300 Grade 2 10
Genitourinary n=300 Grade 0 262
Genitourinary n=300 Grade 1 29
Genitourinary n=300 Grade 2 9
Gynecologic n=108 Grade 0 68
Gynecologic n=108 Grade 1 15
Gynecologic n=108 Grade 2 25
Intracerebral hemorrhage n=300 Grade 0 297
Intracerebral hemorrhage n=300 Grade 1 3
Intracerebral hemorrhage n=300 Grade 2 0
Ocular n=300 Grade 0 258
Ocular n=300 Grade 1 37
Ocular n=300 Grade 2 5
Oral n=300 Grade 0 191
Oral n=300 Grade 1 81
Oral n=300 Grade 2 28
Pulmonary n=300 Grade 0 287
Pulmonary n=300 Grade 1 13
Pulmonary n=300 Grade 2 0
Skin, ecchymosis n=300 Grade 0 74
Skin, ecchymosis n=300 Grade 1 159
Skin, ecchymosis n=300 Grade 2 67
Skin, petechiae n=300 Grade 0 142
Skin, petechiae n=300 Grade 1 126
Skin, petechiae n=300 Grade 2 32
8.Secondary Outcome
Title Best Post-Baseline Change in SF-36v2 Questionnaire Score From Any Time Point Compared With Baseline
Hide Description The SF-36v2 assessment tool was used to obtain information about subjects’ general health status and health-related quality of life. Until a formal assessment of minimal clinically important differences (MCID) is performed, changes from baseline of more than 0.5 standard deviations are suggested as clinically meaningful. Scores were transformed to a 0-100 point scale, with higher scores representing more positive answers. Scores were normalized to have a mean of 50 and SD of 10 to allow for comparison with outcomes from other chronic diseases. Recall period is the past week prior to administration. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group
Time Frame Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
Overall Number of Participants Analyzed 290
Mean (95% Confidence Interval)
Unit of Measure: Points on a scale
SF-36v2 Physical function (n=273
12.0
(9.6 to 14.5)
SF-36v2 Physical role (n=273)
14.2
(11.5 to 16.9)
SF-36v2 Bodily pain (n=273)
14.5
(11.6 to 17.4)
SF-36v2 General health (n=273)
11.1
(9.0 to 13.1)
SF-36v2 Vitality (n=290)
13.9
(11.6 to 16.3)
SF-36v2 Social function (n=290)
12.6
(10.2 to 15.1)
SF-36v2 Emotional role (n=290)
11.4
(8.7 to 14.0)
SF-36v2 Mental health (n=290)
11.3
(9.4 to 13.3)
SF-36v2 Physical component summary (n=273)
5.3
(4.5 to 6.2)
SF-36v2 Mental component summary (n=290)
5.8
(4.6 to 6.9)
9.Secondary Outcome
Title Best Post-Baseline Change in the Short Form of the Motivation and Energy Scale (MEI-SF) From Any Time Point Compared With Baseline
Hide Description The MEI-SF (18 questions) was used to measure the reductions in mental energy, physical energy, and social motivation, either as symptoms of chronic ITP or as a side effect of pharmacotherapy. Minimal clinically important differences are estimated as 0.5 standard deviations or 7.5 points. All items use either a 7-level (0 to 6) or 5-level (0 to 4) response scale; items with a 5-level response scale were rescaled to 7-levels, and items were reverse-scored as necessary such that higher scores represent higher HRQoL Total score ranges from 0 to 108 points. Recall period is past week prior to administration. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group
Time Frame Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
Overall Number of Participants Analyzed 292
Mean (95% Confidence Interval)
Unit of Measure: Points on a scale
11.3
(9.1 to 13.5)
10.Secondary Outcome
Title Best Post-Baseline Change in the FACIT-Fatigue 13 Item Subscale Score From Any Time Point Compared to Baseline
Hide Description

The FACIT-Fatigue consists of 13 questions in which patients rate the frequency (0-4) of symptoms of fatigue, in terms of tiredness, weakness, and fatigue Items were reverse-scored as necessary such that higher scores represent higher HRQoL Total score ranges from 0 to 52.Using anchor-based estimates, the minimally important difference in this subscale is 3.0 points.

Recall period is past week prior to administration. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group

Time Frame Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
Overall Number of Participants Analyzed 291
Mean (95% Confidence Interval)
Unit of Measure: Points on a scale
6.9
(5.7 to 8.1)
11.Secondary Outcome
Title Best Post-Baseline Change in the FACT-TH6 at Any Time Point Compared to Baseline
Hide Description The FACT-TH6 consists of 6 questions in which patients rate (0-4) their general degree of worry related to bleeding and bruising, and resulting activity impairment and frustration. Although the six items do not constitute a formal domain or subscale of the FACT‑Th assessment tool, these items had been identified by focus groups of patients with chronic ITP as important indicators of their HRQoL. Items were reverse-scored as necessary such that higher scores represent higher HRQoL. Total scores ranged from 0 to 24. Recall period is not specified. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group
Time Frame Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
Overall Number of Participants Analyzed 288
Mean (95% Confidence Interval)
Unit of Measure: Points on a scale
4.0
(3.4 to 4.6)
Time Frame Treatment + 1 Day: start date was between the first dose of investigational product and up to the day after the last dose . Post-therapy: start date was more than 1 day after the last dose and up to 30 days after last dose of investigational product
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eltrombopag, Treatment + 1 Day Eltrombopag, >1 to 30 Days Post-Therapy
Hide Arm/Group Description Eltrombopag, Treatment + 1 day Eltrombopag, >1 to 30 Days Post-Therapy
All-Cause Mortality
Eltrombopag, Treatment + 1 Day Eltrombopag, >1 to 30 Days Post-Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Eltrombopag, Treatment + 1 Day Eltrombopag, >1 to 30 Days Post-Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   96/302 (31.79%)   10/302 (3.31%) 
Blood and lymphatic system disorders     
Anaemia  1  5/302 (1.66%)  1/302 (0.33%) 
Bone marrow oedema  1  1/302 (0.33%)  0/302 (0.00%) 
Haemolytic anaemia  1  1/302 (0.33%)  0/302 (0.00%) 
Immune thrombocytopenic purpura  1  1/302 (0.33%)  1/302 (0.33%) 
Neutropenia  1  1/302 (0.33%)  0/302 (0.00%) 
Splenic cyst  1  1/302 (0.33%)  0/302 (0.00%) 
Thrombocytopenia  1  2/302 (0.66%)  1/302 (0.33%) 
Cardiac disorders     
Acute myocardial infarction  1  2/302 (0.66%)  0/302 (0.00%) 
Angina pectoris  1  1/302 (0.33%)  0/302 (0.00%) 
Arrhythmia  1  1/302 (0.33%)  0/302 (0.00%) 
Atrial fibrillation  1  1/302 (0.33%)  0/302 (0.00%) 
Cardiac failure congestive  1  1/302 (0.33%)  0/302 (0.00%) 
Coronary artery occlusion  1  0/302 (0.00%)  1/302 (0.33%) 
Mitral valve incompetence  1  1/302 (0.33%)  0/302 (0.00%) 
Myocardial infarction  1  2/302 (0.66%)  0/302 (0.00%) 
Supraventricular tachycardia  1  0/302 (0.00%)  1/302 (0.33%) 
Tachyarrhythmia  1  1/302 (0.33%)  0/302 (0.00%) 
Eye disorders     
Cataract  1  16/302 (5.30%)  0/302 (0.00%) 
Cataract subcapsular  1  1/302 (0.33%)  0/302 (0.00%) 
Choroidal neovascularisation  1  1/302 (0.33%)  0/302 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/302 (0.00%)  1/302 (0.33%) 
Diarrhoea  1  1/302 (0.33%)  0/302 (0.00%) 
Gastritis  1  1/302 (0.33%)  0/302 (0.00%) 
Gastroduodenitis haemorrhagic  1  1/302 (0.33%)  0/302 (0.00%) 
Gastrointestinal haemorrhage  1  2/302 (0.66%)  0/302 (0.00%) 
Gingival bleeding  1  1/302 (0.33%)  0/302 (0.00%) 
Haematemesis  1  1/302 (0.33%)  0/302 (0.00%) 
Haemorrhoidal haemorrhage  1  2/302 (0.66%)  0/302 (0.00%) 
Haemorrhoids  1  1/302 (0.33%)  0/302 (0.00%) 
Incarcerated umbilical hernia  1  1/302 (0.33%)  0/302 (0.00%) 
Large intestine polyp  1  1/302 (0.33%)  0/302 (0.00%) 
Melaena  1  1/302 (0.33%)  0/302 (0.00%) 
Mouth haemorrhage  1  1/302 (0.33%)  0/302 (0.00%) 
Pancreatitis  1  1/302 (0.33%)  0/302 (0.00%) 
Rectal haemorrhage  1  1/302 (0.33%)  0/302 (0.00%) 
Umbilical hernia  1  1/302 (0.33%)  0/302 (0.00%) 
Vomiting  1  1/302 (0.33%)  0/302 (0.00%) 
General disorders     
Chest pain  1  1/302 (0.33%)  0/302 (0.00%) 
Death  1  1/302 (0.33%)  0/302 (0.00%) 
Gait disturbance  1  1/302 (0.33%)  0/302 (0.00%) 
Generalised oedema  1  1/302 (0.33%)  0/302 (0.00%) 
Local swelling  1  1/302 (0.33%)  0/302 (0.00%) 
Medical device pain  1  1/302 (0.33%)  0/302 (0.00%) 
Multi-organ failure  1  1/302 (0.33%)  0/302 (0.00%) 
Non-cardiac chest pain  1  1/302 (0.33%)  0/302 (0.00%) 
Pyrexia  1  1/302 (0.33%)  0/302 (0.00%) 
Hepatobiliary disorders     
Cholangitis acute  1  1/302 (0.33%)  0/302 (0.00%) 
Cholecystitis acute  1  2/302 (0.66%)  0/302 (0.00%) 
Gallbladder pain  1  1/302 (0.33%)  0/302 (0.00%) 
Hyperbilirubinaemia  1  1/302 (0.33%)  0/302 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1  1/302 (0.33%)  0/302 (0.00%) 
Infections and infestations     
Cellulitis  1  2/302 (0.66%)  0/302 (0.00%) 
Chronic sinusitis  1  1/302 (0.33%)  0/302 (0.00%) 
Cystitis  1  1/302 (0.33%)  0/302 (0.00%) 
Diverticulitis  1  1/302 (0.33%)  0/302 (0.00%) 
Gastroenteritis  1  1/302 (0.33%)  0/302 (0.00%) 
Gastroenteritis viral  1  1/302 (0.33%)  0/302 (0.00%) 
Infection  1  2/302 (0.66%)  0/302 (0.00%) 
Infective exacerbation of chronic obstructive airways disease  1  1/302 (0.33%)  0/302 (0.00%) 
Influenza  1  1/302 (0.33%)  0/302 (0.00%) 
Kidney infection  1  1/302 (0.33%)  0/302 (0.00%) 
Lower respiratory tract infection  1  1/302 (0.33%)  0/302 (0.00%) 
Paronychia  1  1/302 (0.33%)  0/302 (0.00%) 
Pneumonia  1  8/302 (2.65%)  1/302 (0.33%) 
Sepsis  1  1/302 (0.33%)  0/302 (0.00%) 
Septic shock  1  1/302 (0.33%)  0/302 (0.00%) 
Subcutaneous abscess  1  1/302 (0.33%)  0/302 (0.00%) 
Tooth abscess  1  1/302 (0.33%)  0/302 (0.00%) 
Upper respiratory tract infection  1  1/302 (0.33%)  0/302 (0.00%) 
Urinary tract infection  1  3/302 (0.99%)  0/302 (0.00%) 
Wound infection  1  1/302 (0.33%)  0/302 (0.00%) 
Injury, poisoning and procedural complications     
Brain contusion  1  1/302 (0.33%)  0/302 (0.00%) 
Cataract traumatic  1  1/302 (0.33%)  0/302 (0.00%) 
Eye injury  1  1/302 (0.33%)  0/302 (0.00%) 
Femoral neck fracture  1  1/302 (0.33%)  0/302 (0.00%) 
Forearm fracture  1  1/302 (0.33%)  0/302 (0.00%) 
Hip fracture  1  1/302 (0.33%)  0/302 (0.00%) 
Radius fracture  1  1/302 (0.33%)  0/302 (0.00%) 
Road traffic accident  1  1/302 (0.33%)  0/302 (0.00%) 
Spinal cord injury  1  1/302 (0.33%)  0/302 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  5/302 (1.66%)  0/302 (0.00%) 
Aspartate aminotransferase increased  1  4/302 (1.32%)  0/302 (0.00%) 
Blood bilirubin increased  1  4/302 (1.32%)  0/302 (0.00%) 
Hepatic enzyme increased  1  1/302 (0.33%)  0/302 (0.00%) 
Platelet count decreased  1  3/302 (0.99%)  0/302 (0.00%) 
Transaminases increased  1  1/302 (0.33%)  0/302 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/302 (0.33%)  0/302 (0.00%) 
Diabetic ketoacidosis  1  1/302 (0.33%)  0/302 (0.00%) 
Hyperglycaemia  1  1/302 (0.33%)  0/302 (0.00%) 
Hyperosmolar state  1  1/302 (0.33%)  0/302 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/302 (0.66%)  0/302 (0.00%) 
Arthritis  1  1/302 (0.33%)  0/302 (0.00%) 
Back pain  1  2/302 (0.66%)  0/302 (0.00%) 
Muscle haemorrhage  1  1/302 (0.33%)  0/302 (0.00%) 
Osteoarthritis  1  1/302 (0.33%)  0/302 (0.00%) 
Rotator cuff syndrome  1  1/302 (0.33%)  0/302 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma  1  1/302 (0.33%)  0/302 (0.00%) 
B-cell unclassifiable lymphoma low grade  1  1/302 (0.33%)  0/302 (0.00%) 
Basal cell carcinoma  1  2/302 (0.66%)  0/302 (0.00%) 
Breast cancer  1  1/302 (0.33%)  0/302 (0.00%) 
Hodgkin's disease  1  1/302 (0.33%)  0/302 (0.00%) 
Lymphoma  1  1/302 (0.33%)  0/302 (0.00%) 
Ovarian cancer  1  1/302 (0.33%)  0/302 (0.00%) 
Papillary thyroid cancer  1  1/302 (0.33%)  0/302 (0.00%) 
Transitional cell carcinoma  1  1/302 (0.33%)  0/302 (0.00%) 
Nervous system disorders     
Cerebral haemorrhage  1  1/302 (0.33%)  0/302 (0.00%) 
Cerebral infarction  1  2/302 (0.66%)  0/302 (0.00%) 
Cerebral ischaemia  1  1/302 (0.33%)  0/302 (0.00%) 
Dizziness  1  1/302 (0.33%)  1/302 (0.33%) 
Embolic cerebral infarction  1  1/302 (0.33%)  0/302 (0.00%) 
Headache  1  1/302 (0.33%)  0/302 (0.00%) 
Memory impairment  1  1/302 (0.33%)  0/302 (0.00%) 
Optic neuritis  1  1/302 (0.33%)  0/302 (0.00%) 
Paraesthesia  1  0/302 (0.00%)  1/302 (0.33%) 
Presyncope  1  1/302 (0.33%)  0/302 (0.00%) 
Subarachnoid haemorrhage  1  2/302 (0.66%)  0/302 (0.00%) 
Syncope  1  1/302 (0.33%)  0/302 (0.00%) 
Toxic neuropathy  1  1/302 (0.33%)  0/302 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Ectopic pregnancy  1  1/302 (0.33%)  0/302 (0.00%) 
Psychiatric disorders     
Confusional state  1  0/302 (0.00%)  1/302 (0.33%) 
Mental status changes  1  0/302 (0.00%)  1/302 (0.33%) 
Renal and urinary disorders     
Acute kidney injury  1  1/302 (0.33%)  0/302 (0.00%) 
Calculus urinary  1  1/302 (0.33%)  0/302 (0.00%) 
Lupus nephritis  1  1/302 (0.33%)  0/302 (0.00%) 
Renal failure  1  1/302 (0.33%)  0/302 (0.00%) 
Renal mass  1  1/302 (0.33%)  0/302 (0.00%) 
Reproductive system and breast disorders     
Ovarian cyst ruptured  1  0/302 (0.00%)  1/302 (0.33%) 
Uterine polyp  1  1/302 (0.33%)  0/302 (0.00%) 
Vaginal haemorrhage  1  1/302 (0.33%)  0/302 (0.00%) 
Vaginal prolapse  1  1/302 (0.33%)  0/302 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/302 (0.33%)  0/302 (0.00%) 
Chronic obstructive pulmonary disease  1  1/302 (0.33%)  0/302 (0.00%) 
Dyspnoea  1  1/302 (0.33%)  0/302 (0.00%) 
Epistaxis  1  4/302 (1.32%)  0/302 (0.00%) 
Haemoptysis  1  2/302 (0.66%)  0/302 (0.00%) 
Pulmonary embolism  1  2/302 (0.66%)  1/302 (0.33%) 
Pulmonary infarction  1  1/302 (0.33%)  0/302 (0.00%) 
Respiratory failure  1  1/302 (0.33%)  0/302 (0.00%) 
Skin and subcutaneous tissue disorders     
Erythema nodosum  1  1/302 (0.33%)  0/302 (0.00%) 
Swelling face  1  1/302 (0.33%)  0/302 (0.00%) 
Vascular disorders     
Arteriovenous fistula  1  1/302 (0.33%)  0/302 (0.00%) 
Deep vein thrombosis  1  4/302 (1.32%)  0/302 (0.00%) 
Haematoma  1  1/302 (0.33%)  0/302 (0.00%) 
Hypertension  1  2/302 (0.66%)  0/302 (0.00%) 
Hypotension  1  1/302 (0.33%)  0/302 (0.00%) 
Thrombophlebitis superficial  1  1/302 (0.33%)  0/302 (0.00%) 
Thrombosis  1  1/302 (0.33%)  0/302 (0.00%) 
Indicates events were collected by systematic assessment
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, Treatment + 1 Day Eltrombopag, >1 to 30 Days Post-Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   253/302 (83.77%)   28/302 (9.27%) 
Blood and lymphatic system disorders     
Anaemia  1  26/302 (8.61%)  1/302 (0.33%) 
Gastrointestinal disorders     
Abdominal pain  1  18/302 (5.96%)  0/302 (0.00%) 
Abdominal pain upper  1  18/302 (5.96%)  1/302 (0.33%) 
Constipation  1  26/302 (8.61%)  2/302 (0.66%) 
Diarrhoea  1  46/302 (15.23%)  3/302 (0.99%) 
Nausea  1  34/302 (11.26%)  1/302 (0.33%) 
Vomiting  1  19/302 (6.29%)  2/302 (0.66%) 
General disorders     
Fatigue  1  50/302 (16.56%)  4/302 (1.32%) 
Influenza like illness  1  25/302 (8.28%)  1/302 (0.33%) 
Pyrexia  1  27/302 (8.94%)  2/302 (0.66%) 
Infections and infestations     
Bronchitis  1  25/302 (8.28%)  0/302 (0.00%) 
Cystitis  1  16/302 (5.30%)  0/302 (0.00%) 
Influenza  1  29/302 (9.60%)  0/302 (0.00%) 
Nasopharyngitis  1  74/302 (24.50%)  2/302 (0.66%) 
Pharyngitis  1  21/302 (6.95%)  0/302 (0.00%) 
Sinusitis  1  20/302 (6.62%)  1/302 (0.33%) 
Upper respiratory tract infection  1  69/302 (22.85%)  5/302 (1.66%) 
Urinary tract infection  1  32/302 (10.60%)  2/302 (0.66%) 
Viral infection  1  23/302 (7.62%)  0/302 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  23/302 (7.62%)  0/302 (0.00%) 
Aspartate aminotransferase increased  1  21/302 (6.95%)  0/302 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  45/302 (14.90%)  0/302 (0.00%) 
Back pain  1  39/302 (12.91%)  0/302 (0.00%) 
Pain in extremity  1  28/302 (9.27%)  0/302 (0.00%) 
Nervous system disorders     
Dizziness  1  26/302 (8.61%)  0/302 (0.00%) 
Headache  1  86/302 (28.48%)  3/302 (0.99%) 
Psychiatric disorders     
Insomnia  1  27/302 (8.94%)  2/302 (0.66%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  32/302 (10.60%)  0/302 (0.00%) 
Epistaxis  1  23/302 (7.62%)  2/302 (0.66%) 
Oropharyngeal pain  1  27/302 (8.94%)  1/302 (0.33%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  17/302 (5.63%)  1/302 (0.33%) 
Rash  1  25/302 (8.28%)  0/302 (0.00%) 
Vascular disorders     
Hypertension  1  22/302 (7.28%)  1/302 (0.33%) 
Indicates events were collected by systematic assessment
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.
Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis
Phone: 862-778-8300
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00351468     History of Changes
Other Study ID Numbers: TRA105325
First Submitted: July 10, 2006
First Posted: July 12, 2006
Results First Submitted: July 6, 2016
Results First Posted: April 17, 2017
Last Update Posted: April 17, 2017