Trial Outcomes & Findings for Repeated Exposure to Eltrombopag in Adults With Idiopathic Thrombocytopenic Purpura (REPEAT) (NCT NCT00424177)
NCT ID: NCT00424177
Last Updated: 2013-07-30
Results Overview
Complete blood count, platelet count by blood draw
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Day 42 of each cycle
Results posted on
2013-07-30
Participant Flow
Participant milestones
| Measure |
Treatment Period
Three cycles of treatment. A cycle is defined as an on-therapy period of up to 6 weeks and an off-therapy period of up to 4 weeks.
|
|---|---|
|
Cycle 1: Eltrombopag 50 mg Starting Dose
STARTED
|
66
|
|
Cycle 1: Eltrombopag 50 mg Starting Dose
COMPLETED
|
55
|
|
Cycle 1: Eltrombopag 50 mg Starting Dose
NOT COMPLETED
|
11
|
|
Cycle 2: Eltrombopag 50 or 75 mg
STARTED
|
55
|
|
Cycle 2: Eltrombopag 50 or 75 mg
COMPLETED
|
51
|
|
Cycle 2: Eltrombopag 50 or 75 mg
NOT COMPLETED
|
4
|
|
Cycle 3: Eltrombopag 50 or 75 mg
STARTED
|
51
|
|
Cycle 3: Eltrombopag 50 or 75 mg
COMPLETED
|
48
|
|
Cycle 3: Eltrombopag 50 or 75 mg
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Treatment Period
Three cycles of treatment. A cycle is defined as an on-therapy period of up to 6 weeks and an off-therapy period of up to 4 weeks.
|
|---|---|
|
Cycle 1: Eltrombopag 50 mg Starting Dose
Lack of Efficacy
|
8
|
|
Cycle 1: Eltrombopag 50 mg Starting Dose
Adverse Event
|
1
|
|
Cycle 1: Eltrombopag 50 mg Starting Dose
Prolonged Response
|
1
|
|
Cycle 1: Eltrombopag 50 mg Starting Dose
Relocation
|
1
|
|
Cycle 2: Eltrombopag 50 or 75 mg
Lack of Efficacy
|
2
|
|
Cycle 2: Eltrombopag 50 or 75 mg
Prolonged Response
|
1
|
|
Cycle 2: Eltrombopag 50 or 75 mg
Withdrawal by Subject
|
1
|
|
Cycle 3: Eltrombopag 50 or 75 mg
Lack of Efficacy
|
1
|
|
Cycle 3: Eltrombopag 50 or 75 mg
Withdrawal by Subject
|
1
|
|
Cycle 3: Eltrombopag 50 or 75 mg
Physician Decision
|
1
|
Baseline Characteristics
Repeated Exposure to Eltrombopag in Adults With Idiopathic Thrombocytopenic Purpura (REPEAT)
Baseline characteristics by cohort
| Measure |
Overall Study Population
n=66 Participants
Male and female participants greater than or equal to 18 years of age with previously treated chronic ITP, as defined according to the American Society of Hematology/British Committee for Standards in Hematology guidelines, who had platelet counts between greater than or equal to 20 gi/L and less than or equal to 50 Gi/L, on the Day 1 visit (or within 24 hours prior to dosing on Day 1).
|
|---|---|
|
Age Continuous
|
49.6 years
STANDARD_DEVIATION 14.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European
|
47 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
|
Baseline Platelet Count
Less than 20 giga per liter (Gi/L)
|
4 participants
n=5 Participants
|
|
Baseline Platelet Count
20 Gi/L to 30 Gi/L
|
29 participants
n=5 Participants
|
|
Baseline Platelet Count
Greater than 30 Gi/L to 50 Gi/L
|
31 participants
n=5 Participants
|
|
Baseline Platelet Count
Greater than 50 Gi/L
|
2 participants
n=5 Participants
|
|
Baseline Splenectomy Status
Yes
|
20 participants
n=5 Participants
|
|
Baseline Splenectomy Status
No
|
46 participants
n=5 Participants
|
|
Use of Idiopathic Thrombocytopenic Purpura Medication at Baseline
Yes
|
22 participants
n=5 Participants
|
|
Use of Idiopathic Thrombocytopenic Purpura Medication at Baseline
No
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 42 of each cyclePopulation: Primary Analysis Population: All participants who entered the study, received at least 1 dose of eltrombopag, and responded in Cycle 1
Complete blood count, platelet count by blood draw
Outcome measures
| Measure |
Cycle 1
n=52 Participants
Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
|
Cycle 2
n=51 Participants
Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
|
Cycle 3
n=49 Participants
Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
|
|---|---|---|---|
|
Number of Participants Who Responded (Platelet Count >=50 Gi/L and >=2x Baseline) to Eltrombopag Treatment in Cycle 2 or Cycle 3 Given Participants Responded in Cycle 1
Responders
|
52 participants
|
41 participants
|
38 participants
|
|
Number of Participants Who Responded (Platelet Count >=50 Gi/L and >=2x Baseline) to Eltrombopag Treatment in Cycle 2 or Cycle 3 Given Participants Responded in Cycle 1
Non-responders
|
0 participants
|
10 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Up to 42 days of dosingPopulation: Cycle 1 responders
CBC, platelet counts
Outcome measures
| Measure |
Cycle 1
n=48 Participants
Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
|
Cycle 2
n=45 Participants
Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
|
Cycle 3
n=43 Participants
Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
|
|---|---|---|---|
|
Number of Participants Who Responded (Platelet Count Greater Than or Equal to 50 Gi/L and at Least 2x Baseline) for at Least 80 Percent of Their On-therapy Assessments During Weeks 2-6.
At least 80 percent of assessments met criteria
|
38 participants
|
35 participants
|
30 participants
|
|
Number of Participants Who Responded (Platelet Count Greater Than or Equal to 50 Gi/L and at Least 2x Baseline) for at Least 80 Percent of Their On-therapy Assessments During Weeks 2-6.
Less than 80 percent of assessments met criteria
|
10 participants
|
10 participants
|
13 participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Intent-to-Treat (ITT) Population: All participants who were dispensed study medication
Changes from baseline, during on-therapy periods of a cycle, during off-therapy periods of a cycle, and within 4 weeks of permanent discontinuation of eltrombopag treatment.
Outcome measures
| Measure |
Cycle 1
n=52 Participants
Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
|
Cycle 2
n=52 Participants
Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
|
Cycle 3
n=49 Participants
Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
|
|---|---|---|---|
|
Changes in Participants' Platelet Counts During 3 Cycles of Treatment
Baseline platelet count
|
33.0 Gi/L
Interval 7.0 to 82.0
|
25.0 Gi/L
Interval 0.0 to 66.0
|
26.0 Gi/L
Interval 8.0 to 167.0
|
|
Changes in Participants' Platelet Counts During 3 Cycles of Treatment
Highest on-therapy platelet count
|
200.5 Gi/L
Interval 52.0 to 762.0
|
196.0 Gi/L
Interval 31.0 to 613.0
|
174.0 Gi/L
Interval 10.0 to 366.0
|
|
Changes in Participants' Platelet Counts During 3 Cycles of Treatment
Lowest on-therapy platelet count
|
72.0 Gi/L
Interval 6.0 to 354.0
|
67.5 Gi/L
Interval 7.0 to 454.0
|
59.0 Gi/L
Interval 2.0 to 344.0
|
|
Changes in Participants' Platelet Counts During 3 Cycles of Treatment
Highest off-therapy platelet count
|
118.5 Gi/L
Interval 0.0 to 662.0
|
92.5 Gi/L
Interval 12.0 to 701.0
|
125.0 Gi/L
Interval 21.0 to 594.0
|
|
Changes in Participants' Platelet Counts During 3 Cycles of Treatment
Lowest off-therapy platelet count
|
21.0 Gi/L
Interval 0.0 to 59.0
|
22.5 Gi/L
Interval 8.0 to 75.0
|
22.0 Gi/L
Interval 0.0 to 187.0
|
SECONDARY outcome
Timeframe: Up to 3 cycles of treatment including follow-up visits following last dose of eltrombopagPopulation: ITT Population
New idiopathic thrombocytopenic purpura (ITP) medication, increase dose of a concomitant ITP medication from baseline, platelet transfusion, and/or splenectomy
Outcome measures
| Measure |
Cycle 1
n=66 Participants
Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
|
Cycle 2
n=55 Participants
Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
|
Cycle 3
n=51 Participants
Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
|
|---|---|---|---|
|
Number of Participants Who Required Rescue Medication
Participants who required rescue treatment
|
2 participants
|
2 participants
|
10 participants
|
|
Number of Participants Who Required Rescue Medication
Participants who did not require rescue treatment
|
64 participants
|
53 participants
|
41 participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Safety Population: any participant who received at least 1 dose of study medication
Change in participants' anti-platelet antibody levels was measured as the number of samples positive for at least 1 glycoprotein from baseline to follow-up. Serum glycoprotein-specific antigens: GPIIb/IIIa, Ib/IX, and Ia/IIa
Outcome measures
| Measure |
Cycle 1
n=64 Participants
Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
|
Cycle 2
Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
|
Cycle 3
Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
|
|---|---|---|---|
|
Change in Participants Anti-platelet Antibody Levels From Baseline Through Follow-up
Baseline
|
12 participants
|
—
|
—
|
|
Change in Participants Anti-platelet Antibody Levels From Baseline Through Follow-up
Cycle 2 on-therapy
|
6 participants
|
—
|
—
|
|
Change in Participants Anti-platelet Antibody Levels From Baseline Through Follow-up
Cycle 3 on-therapy
|
7 participants
|
—
|
—
|
|
Change in Participants Anti-platelet Antibody Levels From Baseline Through Follow-up
4-week follow-up
|
8 participants
|
—
|
—
|
|
Change in Participants Anti-platelet Antibody Levels From Baseline Through Follow-up
3-month follow-up
|
1 participants
|
—
|
—
|
|
Change in Participants Anti-platelet Antibody Levels From Baseline Through Follow-up
6-month follow-up
|
3 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, on-treatment visits (Weeks 1-6), off-treatment visits (Weeks 1-4)Population: Participants who responded in Cycle 1
World health Organization (WHO) Bleeding Scale Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross blood loss, Grade 4 = debilitating blood loss.
Outcome measures
| Measure |
Cycle 1
n=52 Participants
Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
|
Cycle 2
n=52 Participants
Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
|
Cycle 3
n=49 Participants
Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
|
|---|---|---|---|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 5, Grade 0
|
24 participants
|
20 participants
|
24 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 5, Grades 1-4
|
4 participants
|
6 participants
|
5 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 5, Grades 2-4
|
1 participants
|
3 participants
|
1 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 6 (Day 43), n
|
25 participants
|
26 participants
|
27 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 6, Grade 0
|
22 participants
|
22 participants
|
22 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 6, Grades 1-4
|
3 participants
|
4 participants
|
5 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 6, Grades 2-4
|
0 participants
|
4 participants
|
1 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
Off-therapy, Week 1 (Day 8), n
|
47 participants
|
45 participants
|
46 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
Off-therapy, Week 1, Grade 0
|
37 participants
|
35 participants
|
42 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
Off-therapy, Week 1, Grades 1-4
|
10 participants
|
10 participants
|
4 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
Off-therapy, Week 1, Grades 2-4
|
4 participants
|
4 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
Off-therapy, Week 2 (Day 15), n
|
37 participants
|
35 participants
|
45 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
Off-therapy, Week 2, Grade 0
|
26 participants
|
25 participants
|
30 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
Off-therapy, Week 2, Grades 1-4
|
11 participants
|
10 participants
|
15 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
Off-therapy, Week 2, Grades 2-4
|
2 participants
|
3 participants
|
2 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
Off-therapy, Week 3 (Day 22), n
|
28 participants
|
30 participants
|
46 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
Off-therapy, Week 3, Grade 0
|
18 participants
|
19 participants
|
30 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
Off-therapy, Week 3, Grades 1-4
|
10 participants
|
11 participants
|
16 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
Off-therapy, Week 3, Grades 2-4
|
2 participants
|
4 participants
|
7 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
Off-therapy, Week 4 (Day 29), n
|
7 participants
|
12 participants
|
48 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
Off-therapy, Week 4, Grade 0
|
5 participants
|
9 participants
|
30 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
Off-therapy, Week 4, Grades 1-4
|
2 participants
|
3 participants
|
18 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
Off-therapy, Week 4, Grades 2-4
|
1 participants
|
2 participants
|
6 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 0 (Day 1), n
|
52 participants
|
52 participants
|
49 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 0, Grade 0
|
26 participants
|
21 participants
|
32 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 0, Grades 1-4
|
26 participants
|
31 participants
|
17 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 0, Grades 2-4
|
10 participants
|
10 participants
|
6 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 1 (Day 8), n
|
51 participants
|
51 participants
|
49 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 1, Grade 0
|
34 participants
|
36 participants
|
37 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 1, Grades 1-4
|
17 participants
|
15 participants
|
12 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 1, Grades 2-4
|
4 participants
|
2 participants
|
3 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 2 (Day 15), n
|
47 participants
|
45 participants
|
43 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 2, Grade 0
|
35 participants
|
38 participants
|
32 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 2, Grades 1-4
|
12 participants
|
7 participants
|
11 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 2, Grades 2-4
|
4 participants
|
2 participants
|
4 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 3 (Day 22), n
|
33 participants
|
32 participants
|
33 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 3, Grade 0
|
28 participants
|
25 participants
|
26 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 3, Grades 1-4
|
5 participants
|
7 participants
|
7 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 3, Grades 2-4
|
3 participants
|
2 participants
|
2 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 4 (Day 29), n
|
31 participants
|
28 participants
|
29 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 4, Grade 0
|
23 participants
|
22 participants
|
24 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 4, Grade 1-4
|
8 participants
|
6 participants
|
5 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 4, Grade 2-4
|
2 participants
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale
On-therapy, Week 5 (Day 36), n
|
28 participants
|
26 participants
|
29 participants
|
SECONDARY outcome
Timeframe: Baseline, on-treatment visits (Weeks 1-6), off-treatment visits (Weeks 1-4)Population: Participants who responded in Cycle 1
ITP Bleeding Score: Grade 0 = no bleeding, Grade 1 = mild bleeding, Grade 2 = severe bleeding
Outcome measures
| Measure |
Cycle 1
n=52 Participants
Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
|
Cycle 2
n=52 Participants
Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
|
Cycle 3
n=49 Participants
Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
|
|---|---|---|---|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 1, Grade 2
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 2 (Day 15), n
|
47 participants
|
45 participants
|
42 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 2, Grade 0
|
42 participants
|
38 participants
|
32 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 2, Grade 1
|
5 participants
|
7 participants
|
9 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 2, Grade 2
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 3 (Day 22), n
|
33 participants
|
32 participants
|
33 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 3, Grade 0
|
28 participants
|
24 participants
|
29 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 3, Grade 1
|
5 participants
|
8 participants
|
4 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 3, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 4 (Day 29), n
|
31 participants
|
28 participants
|
29 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 4, Grade 0
|
24 participants
|
24 participants
|
25 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 4, Grade 1
|
7 participants
|
4 participants
|
4 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 4, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 5 (Day 36), n
|
28 participants
|
26 participants
|
29 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 5, Grade 0
|
25 participants
|
23 participants
|
25 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 5, Grade 1
|
3 participants
|
3 participants
|
4 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 5, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 6 (Day 43), n
|
24 participants
|
25 participants
|
27 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 6, Grade 0
|
20 participants
|
22 participants
|
25 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 6, Grade 1
|
4 participants
|
3 participants
|
2 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 6, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, off-therapy, Week 1 (Day 1), n
|
47 participants
|
45 participants
|
48 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, off-therapy, Week 1, Grade 0
|
42 participants
|
38 participants
|
43 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, off-therapy, Week 1, Grade 1
|
5 participants
|
7 participants
|
5 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, off-therapy, Week 1, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, off-therapy, Week 2 (Day 15), n
|
36 participants
|
35 participants
|
45 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, off-therapy, Week 2, Grade 0
|
26 participants
|
24 participants
|
36 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, off-therapy, Week 2, Grade 1
|
9 participants
|
11 participants
|
9 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, off-therapy, Week 2, Grade 2
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, off-therapy, Week 3 (Day 22), n
|
29 participants
|
30 participants
|
46 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, off-therapy, Week 3, Grade 0
|
16 participants
|
20 participants
|
31 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, off-therapy, Week 3, Grade 1
|
11 participants
|
9 participants
|
13 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 0, Grade 1
|
16 participants
|
25 participants
|
12 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 0, Grade 2
|
3 participants
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 1 (Day 8), n
|
51 participants
|
51 participants
|
48 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 1, Grade 0
|
39 participants
|
37 participants
|
35 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 1, Grade 1
|
11 participants
|
13 participants
|
12 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 0 (Day 1), n
|
50 participants
|
52 participants
|
49 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 0, Grade 0
|
35 participants
|
35 participants
|
39 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 0, Grade 1
|
14 participants
|
17 participants
|
10 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 0, Grade 2
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 1 (Day 8), n
|
51 participants
|
51 participants
|
48 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 1, Grade 0
|
41 participants
|
46 participants
|
44 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 1, Grade 1
|
10 participants
|
3 participants
|
3 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 1, Grade 2
|
0 participants
|
2 participants
|
1 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 2 (Day 15), n
|
47 participants
|
45 participants
|
42 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 2, Grade 0
|
40 participants
|
43 participants
|
39 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 2, Grade 1
|
7 participants
|
2 participants
|
2 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 2, Grade 2
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 3 (Day 22), n
|
33 participants
|
32 participants
|
33 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 3, Grade 0
|
31 participants
|
28 participants
|
32 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 3, Grade 1
|
2 participants
|
4 participants
|
1 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 3, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 4 (Day 29), n
|
31 participants
|
28 participants
|
29 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 4, Grade 0
|
30 participants
|
24 participants
|
28 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 4, Grade 1
|
1 participants
|
4 participants
|
1 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 4, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 5 (Day 36), n
|
28 participants
|
26 participants
|
29 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 5, Grade 0
|
27 participants
|
21 participants
|
29 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 5, Grade 1
|
1 participants
|
5 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 5, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 6 (Day 43), n
|
24 participants
|
25 participants
|
27 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 6, Grade 0
|
24 participants
|
23 participants
|
27 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 6, Grade 1
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, on-therapy, Week 6, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, off-therapy, Week 1 (Day 8), n
|
47 participants
|
45 participants
|
48 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, off-therapy, Week 1, Grade 0
|
45 participants
|
39 participants
|
45 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, off-therapy, Week 1, Grade 1
|
2 participants
|
6 participants
|
3 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, off-therapy, Week 1, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, off-therapy, Week 2 (Day 15), n
|
36 participants
|
35 participants
|
45 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, off-therapy, Week 2, Grade 0
|
31 participants
|
30 participants
|
40 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, off-therapy, Week 2, Grade 1
|
5 participants
|
5 participants
|
4 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, off-therapy, Week 2, Grade 2
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, off-therapy, Week 3 (Day 22), n
|
29 participants
|
30 participants
|
46 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, off-therapy, Week 3, Grade 0
|
27 participants
|
26 participants
|
39 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, off-therapy, Week 3, Grade 1
|
2 participants
|
4 participants
|
7 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, off-therapy, Week 3, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, off-therapy, Week 4 (Day 29), n
|
7 participants
|
12 participants
|
48 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, off-therapy, Week 4, Grade 0
|
7 participants
|
12 participants
|
41 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, off-therapy, Week 4, Grade 1
|
0 participants
|
0 participants
|
6 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, petechiae, off-therapy, Week 4, Grade 2
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 0 (Day 1), n
|
50 participants
|
52 participants
|
49 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, on-therapy, Week 0, Grade 0
|
31 participants
|
27 participants
|
36 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, off-therapy, Week 3, Grade 2
|
2 participants
|
1 participants
|
2 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, off-therapy, Week 4 (Day 29), n
|
7 participants
|
12 participants
|
48 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, off-therapy, Week 4, Grade 0
|
6 participants
|
9 participants
|
31 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, off-therapy, Week 4, Grade 1
|
0 participants
|
3 participants
|
15 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Skin, ecchymosis, off-therapy, Week 4, Grade 2
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 0 (Day 1), n
|
50 participants
|
52 participants
|
49 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 0, Grade 0
|
46 participants
|
46 participants
|
46 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 0, Grade 1
|
4 participants
|
5 participants
|
3 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 0, Grade 2
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 1 (Day 8), n
|
51 participants
|
51 participants
|
48 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 1, Grade 0
|
49 participants
|
49 participants
|
46 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 1, Grade 1
|
2 participants
|
2 participants
|
2 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 1, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 2 (Day 15), n
|
47 participants
|
45 participants
|
42 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 2, Grade 0
|
46 participants
|
43 participants
|
41 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 2, Grade 1
|
1 participants
|
2 participants
|
1 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 2, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 3 (Day 22), n
|
33 participants
|
32 participants
|
33 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 3, Grade 0
|
33 participants
|
30 participants
|
31 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 3, Grade 1
|
0 participants
|
2 participants
|
2 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 3, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 4 (Day 29), n
|
31 participants
|
28 participants
|
29 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 4, Grade 0
|
30 participants
|
26 participants
|
29 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 4, Grade 1
|
1 participants
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 4, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 5 (Day 36), n
|
28 participants
|
26 participants
|
29 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 5, Grade 0
|
27 participants
|
24 participants
|
29 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 5, Grade 1
|
1 participants
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 5, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 6 (Day 43), n
|
24 participants
|
25 participants
|
27 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 6, Grade 0
|
23 participants
|
23 participants
|
26 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 6, Grade 1
|
1 participants
|
2 participants
|
1 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, on-therapy, Week 6, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, off-therapy, Week 1 (Day 8), n
|
47 participants
|
45 participants
|
48 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, off-therapy, Week 1, Grade 0
|
45 participants
|
43 participants
|
48 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, off-therapy, Week 1, Grade 1
|
2 participants
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, off-therapy, Week 1, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, off-therapy, Week 2 (Day 15), n
|
36 participants
|
35 participants
|
45 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, off-therapy, Week 2, Grade 0
|
36 participants
|
35 participants
|
45 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, off-therapy, Week 2, Grade 1
|
0 participants
|
3 participants
|
3 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, off-therapy, Week 2, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, off-therapy, Week 3 (Day 22), n
|
29 participants
|
30 participants
|
46 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, off-therapy, Week 3, Grade 0
|
27 participants
|
29 participants
|
41 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, off-therapy, Week 3, Grade 1
|
2 participants
|
1 participants
|
5 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, off-therapy, Week 3, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, off-therapy, Week 4 (Day 29), n
|
7 participants
|
12 participants
|
48 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, off-therapy, Week 4, Grade 0
|
7 participants
|
10 participants
|
45 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, off-therapy, Week 4, Grade 1
|
0 participants
|
2 participants
|
2 participants
|
|
Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score
Oral, off-therapy, Week 4, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Cycle 1
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Cycle 2
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Cycle 3
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
More Than 1 to 30 Days After Last Dose
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
More Than 30 Days After Last Dose
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
All Cycles
Serious events: 4 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cycle 1
n=66 participants at risk
Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
|
Cycle 2
n=55 participants at risk
Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
|
Cycle 3
n=51 participants at risk
Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
|
More Than 1 to 30 Days After Last Dose
n=66 participants at risk
Adverse events \>1 to 30 days after last dose (Post-therapy)
|
More Than 30 Days After Last Dose
n=66 participants at risk
Adverse events \>30 days after last dose (Post-therapy)
|
All Cycles
n=66 participants at risk
Participants who reported an AE anytime during 3 cycles of treatment. A cycle consisted of once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/66
|
1.8%
1/55
|
0.00%
0/51
|
0.00%
0/66
|
0.00%
0/66
|
1.5%
1/66
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/66
|
0.00%
0/55
|
0.00%
0/51
|
1.5%
1/66
|
0.00%
0/66
|
1.5%
1/66
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/66
|
0.00%
0/55
|
0.00%
0/51
|
1.5%
1/66
|
0.00%
0/66
|
1.5%
1/66
|
|
Ear and labyrinth disorders
Ear hemorrhage
|
0.00%
0/66
|
0.00%
0/55
|
0.00%
0/51
|
0.00%
0/66
|
1.5%
1/66
|
1.5%
1/66
|
|
Gastrointestinal disorders
Mouth Hemorrhage
|
0.00%
0/66
|
0.00%
0/55
|
0.00%
0/51
|
0.00%
0/66
|
1.5%
1/66
|
1.5%
1/66
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/66
|
0.00%
0/55
|
0.00%
0/51
|
0.00%
0/66
|
1.5%
1/66
|
1.5%
1/66
|
Other adverse events
| Measure |
Cycle 1
n=66 participants at risk
Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
|
Cycle 2
n=55 participants at risk
Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
|
Cycle 3
n=51 participants at risk
Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
|
More Than 1 to 30 Days After Last Dose
n=66 participants at risk
Adverse events \>1 to 30 days after last dose (Post-therapy)
|
More Than 30 Days After Last Dose
n=66 participants at risk
Adverse events \>30 days after last dose (Post-therapy)
|
All Cycles
n=66 participants at risk
Participants who reported an AE anytime during 3 cycles of treatment. A cycle consisted of once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.6%
5/66
|
3.6%
2/55
|
9.8%
5/51
|
4.5%
3/66
|
1.5%
1/66
|
15.2%
10/66
|
|
Infections and infestations
Upper respiratory tract infection
|
3.0%
2/66
|
1.8%
1/55
|
5.9%
3/51
|
4.5%
3/66
|
0.00%
0/66
|
7.6%
5/66
|
|
Infections and infestations
Sinusitis
|
3.0%
2/66
|
3.6%
2/55
|
0.00%
0/51
|
0.00%
0/66
|
0.00%
0/66
|
6.1%
4/66
|
|
Infections and infestations
Gastroenteritis
|
1.5%
1/66
|
0.00%
0/55
|
3.9%
2/51
|
0.00%
0/66
|
1.5%
1/66
|
4.5%
3/66
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
6/66
|
1.8%
1/55
|
5.9%
3/51
|
1.5%
1/66
|
1.5%
1/66
|
12.1%
8/66
|
|
Gastrointestinal disorders
Nausea
|
4.5%
3/66
|
5.5%
3/55
|
0.00%
0/51
|
0.00%
0/66
|
0.00%
0/66
|
7.6%
5/66
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
2/66
|
3.6%
2/55
|
2.0%
1/51
|
0.00%
0/66
|
0.00%
0/66
|
7.6%
5/66
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
1/66
|
1.8%
1/55
|
2.0%
1/51
|
0.00%
0/66
|
0.00%
0/66
|
4.5%
3/66
|
|
Gastrointestinal disorders
Dyspepsia
|
1.5%
1/66
|
1.8%
1/55
|
2.0%
1/51
|
1.5%
1/66
|
0.00%
0/66
|
4.5%
3/66
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
3/66
|
7.3%
4/55
|
2.0%
1/51
|
0.00%
0/66
|
0.00%
0/66
|
10.6%
7/66
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
3/66
|
1.8%
1/55
|
2.0%
1/51
|
1.5%
1/66
|
0.00%
0/66
|
7.6%
5/66
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
3/66
|
0.00%
0/55
|
3.9%
2/51
|
0.00%
0/66
|
0.00%
0/66
|
7.6%
5/66
|
|
General disorders
Fatigue
|
1.5%
1/66
|
9.1%
5/55
|
13.7%
7/51
|
4.5%
3/66
|
0.00%
0/66
|
15.2%
10/66
|
|
General disorders
Pain
|
3.0%
2/66
|
1.8%
1/55
|
0.00%
0/51
|
0.00%
0/66
|
0.00%
0/66
|
4.5%
3/66
|
|
Nervous system disorders
Headache
|
13.6%
9/66
|
18.2%
10/55
|
13.7%
7/51
|
7.6%
5/66
|
0.00%
0/66
|
24.2%
16/66
|
|
Nervous system disorders
Dizziness
|
1.5%
1/66
|
3.6%
2/55
|
2.0%
1/51
|
0.00%
0/66
|
0.00%
0/66
|
4.5%
3/66
|
|
Investigations
Helicobacter pylori
|
0.00%
0/66
|
0.00%
0/55
|
5.9%
3/51
|
3.0%
2/66
|
4.5%
3/66
|
4.5%
3/66
|
|
Investigations
Alanine aminotransferase increased
|
1.5%
1/66
|
1.8%
1/55
|
3.9%
2/51
|
0.00%
0/66
|
1.5%
1/66
|
4.5%
3/66
|
|
Psychiatric disorders
Insomnia
|
3.0%
2/66
|
1.8%
1/55
|
2.0%
1/51
|
0.00%
0/66
|
0.00%
0/66
|
4.5%
3/66
|
|
Psychiatric disorders
Anxiety
|
1.5%
1/66
|
1.8%
1/55
|
2.0%
1/51
|
1.5%
1/66
|
0.00%
0/66
|
4.5%
3/66
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
1/66
|
3.6%
2/55
|
0.00%
0/51
|
0.00%
0/66
|
1.5%
1/66
|
4.5%
3/66
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.5%
1/66
|
0.00%
0/55
|
3.9%
2/51
|
0.00%
0/66
|
0.00%
0/66
|
4.5%
3/66
|
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