Number of Participants With Vital Sign Data Falling Outside the Reference Ranges (RR) at the Indicated Visit During Part 2
Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body. · Source last updated 2015-03-10
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
From Week 1 up to Week 24 of Part 2 and Follow-up Week 1 to Week 4 (up to Week 41)
What was measured
Vital sign measurements were taken before any blood draw and included systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate(HR). The number of participants are reported with vital sign data falling outside the standard RR as reference range high(RRH) and reference range low(RRL) from SCR up to Week 24 of Part 2 and from Follow-up Week 1 to Week 4. RR for Blood Pressure(mmHg) are read as: Lower Limit of Normal, Normal Range, Upper Limit of Normal. For Ages 1 to 5 years (yrs) ranges are SBP \<85, 85 to 115, \>115; DBP \<45, 45 to70, \>70. Ages 6 to 11 yrs: SBP \<85, 85 to 120, \>120; DBP \<50, 50 to 75, \>75. Ages 12 to 17 yrs: SBP \<95, 95 to 135, \>135; DBP \<55, 55 to 85, \>85. RR for HR (bpm) are ages 1 to \< 3 yrs: \<90, 90 to 140, \>140; ages 3 to \< 5 yrs: \<75, 75 to 130, \>130, ages 5 to \< 8yrs: \<65, 65 to 115, \>115; ages 8 to \< 12yrs: \<55, 55 to 110, \>110; and ages 12 to 18 yrs: \<55, 55 to 110, \>110.
Analysis population: Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Groups in this outcome
Part 2 (Open-Label Period) - Eltrombopag
Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Part 2 (Open-Label Period) - Eltrombopag
87
Reported measurements
DBP, Week 1, RRH, n=87
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
14
Not reported
Not reported
Not reported
Not reported
DBP, Week 1, RRL, n=87
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
8
Not reported
Not reported
Not reported
Not reported
DBP, Week 2, RRH, n=86
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
14
Not reported
Not reported
Not reported
Not reported
DBP, Week 2, RRL, n=86
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
8
Not reported
Not reported
Not reported
Not reported
DBP, Week 3, RRH, n=86
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
13
Not reported
Not reported
Not reported
Not reported
DBP, Week 3, RRL, n=86
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
11
Not reported
Not reported
Not reported
Not reported
DBP, Week 4, RRH, n=68
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
10
Not reported
Not reported
Not reported
Not reported
DBP, Week 4, RRL, n=68
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
DBP, Week 5, RRH, n=61
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
DBP, Week 5, RRL, n=61
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
DBP, Week 6, RRH, n=55
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
DBP, Week 6, RRL, n=55
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
DBP, Week 7, RRH, n=52
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
DBP, Week 7, RRL, n=52
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
DBP, Week 8, RRH, n=53
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
DBP, Week 8, RRL, n=53
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
DBP, Week 9, RRH, n=45
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
DBP, Week 9, RRL, n=45
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
DBP, Week 10, RRH, n=42
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
DBP, Week 10, RRL, n=42
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
DBP, Week 11, RRH, n=40
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
DBP, Week 11, RRL, n=40
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
DBP, Week 12, RRH, n=63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
9
Not reported
Not reported
Not reported
Not reported
DBP, Week 12, RRL, n=63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
11
Not reported
Not reported
Not reported
Not reported
DBP, Week 13, RRH, n=29
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
DBP, Week 13, RRL, n=29
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
DBP, Week 14, RRH, n=38
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
DBP, Week 14, RRL, n=38
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
9
Not reported
Not reported
Not reported
Not reported
DBP, Week 15, RRH, n=43
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
DBP, Week 15, RRL, n=43
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
DBP, Week 16, RRH, n=47
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
DBP, Week 16, RRL, n=47
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
DBP, Week 17, RRH, n=37
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
DBP, Week 17, RRL, n=37
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
DBP, Week 18, RRH, n=34
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
DBP, Week 18, RRL, n=34
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
DBP, Week 19, RRH, n=44
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
DBP, Week 19, RRL, n=44
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
DBP, Week 20, RRH, n=39
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
DBP, Week 20, RRL, n=39
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
DBP, Week 21, RRH, n=41
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
9
Not reported
Not reported
Not reported
Not reported
DBP, Week 21, RRL, n=41
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
DBP, Week 22, RRH, n=34
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
DBP, Week 22, RRL, n=34
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
DBP, Week 23, RRH, n=36
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
DBP, Week 23, RRL, n=36
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
DBP, Week 24, RRH, n=79
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
14
Not reported
Not reported
Not reported
Not reported
DBP, Week 24, RRL, n=79
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
10
Not reported
Not reported
Not reported
Not reported
DBP, Follow-Up Week 1, RRH, n=29
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
8
Not reported
Not reported
Not reported
Not reported
DBP, Follow-Up Week 1, RRL, n=29
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
DBP, Follow-Up Week 2, RRH, n=37
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
8
Not reported
Not reported
Not reported
Not reported
DBP, Follow-Up Week 2, RRL, n=37
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
DBP, Follow-Up Week 3, RRH, n=39
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
DBP, Follow-Up Week 3, RRL, n=39
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
DBP, Follow-Up Week 4, RRH, n=67
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
8
Not reported
Not reported
Not reported
Not reported
DBP, Follow-Up Week 4, RRL, n=67
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 1, RRH, n=87
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 1, RRL, n=87
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 2, RRH, n=86
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 2, RRL, n=86
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 3, RRH, n=86
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 3, RRL, n=86
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 4, RRH, n=68
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 4, RRL, n=68
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 5, RRH, n=61
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 5, RRL, n=61
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 6, RRH, n=55
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 6, RRL, n=55
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 7, RRH, n=52
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 7, RRL, n=52
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 8, RRH, n=53
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 8, RRL, n=53
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 9, RRH, n=45
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 9, RRL, n=45
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 10, RRH, n=42
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 10, RRL, n=42
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 11, RRH, n=40
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 11, RRL, n=40
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 12, RRH, n=63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 12, RRL, n=63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 13, RRH, n=29
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 13, RRL, n=29
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 14, RRH, n=38
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 14, RRL, n=38
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 15, RRH, n=43
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 15, RRL, n=43
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 16, RRH, n=47
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 16, RRL, n=47
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 17, RRH, n=37
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 17, RRL, n=37
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 18, RRH, n=34
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 18, RRL, n=34
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 19, RRH, n=44
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 19, RRL, n=44
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 20, RRH, n=39
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 20, RRL, n=39
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 21, RRH, n=41
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 21, RRL, n=41
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 22, RRH, n=34
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 22, RRL, n=34
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 23, RRH, n=36
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 23, RRL, n=36
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 24, RRH, n=79
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Heart Rate, Week 24, RRL, n=79
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Heart Rate, Follow-Up Week 1, RRH, n=29
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Heart Rate, Follow-Up Week 1, RRL, n=29
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Follow-Up Week 2, RRH, n=37
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Heart Rate, Follow-Up Week 2, RRL, n=37
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Heart Rate, Follow-Up Week 3, RRH, n=39
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Heart Rate, Follow-Up Week 3, RRL, n=39
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Heart Rate, Follow-Up Week 4, RRH, n=67
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Heart Rate, Follow-Up Week 4, RRL, n=67
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
SBP, Week 1, RRH, n=87
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
13
Not reported
Not reported
Not reported
Not reported
SBP, Week 1, RRL, n=87
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
9
Not reported
Not reported
Not reported
Not reported
SBP, Week 2, RRH, n=86
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
19
Not reported
Not reported
Not reported
Not reported
SBP, Week 2, RRL, n=86
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
16
Not reported
Not reported
Not reported
Not reported
SBP, Week 3, RRH, n=86
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
15
Not reported
Not reported
Not reported
Not reported
SBP, Week 3, RRL, n=86
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
13
Not reported
Not reported
Not reported
Not reported
SBP, Week 4, RRH, n=68
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
10
Not reported
Not reported
Not reported
Not reported
SBP, Week 4, RRL, n=68
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
SBP, Week 5, RRH, n=61
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
SBP, Week 5, RRL, n=61
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
8
Not reported
Not reported
Not reported
Not reported
SBP, Week 6, RRH, n=55
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
11
Not reported
Not reported
Not reported
Not reported
SBP, Week 6, RRL, n=55
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
SBP, Week 7, RRH, n=52
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
10
Not reported
Not reported
Not reported
Not reported
SBP, Week 7, RRL, n=52
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
SBP, Week 8, RRH, n=53
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
8
Not reported
Not reported
Not reported
Not reported
SBP, Week 8, RRL, n=53
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
SBP, Week 9, RRH, n=45
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
8
Not reported
Not reported
Not reported
Not reported
SBP, Week 9, RRL, n=45
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
9
Not reported
Not reported
Not reported
Not reported
SBP, Week 10, RRH, n=42
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
SBP, Week 10, RRL, n=42
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
SBP, Week 11, RRH, n=40
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
SBP, Week 11, RRL, n=40
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
SBP, Week 12, RRH, n=63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
14
Not reported
Not reported
Not reported
Not reported
SBP, Week 12, RRL, n=63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
10
Not reported
Not reported
Not reported
Not reported
SBP, Week 13, RRH, n=29
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
SBP, Week 13, RRL, n=29
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
SBP, Week 14, RRH, n=38
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
SBP, Week 14, RRL, n=38
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
SBP, Week 15, RRH, n=43
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
9
Not reported
Not reported
Not reported
Not reported
SBP, Week 15, RRL, n=43
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
SBP, Week 16, RRH, n=47
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
SBP, Week 16, RRL, n=47
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
SBP, Week 17, RRH, n=37
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
9
Not reported
Not reported
Not reported
Not reported
SBP, Week 17, RRL, n=37
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
SBP, Week 18, RRH, n=34
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
SBP, Week 18, RRL, n=34
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
SBP, Week 19, RRH, n=44
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
SBP, Week 19, RRL, n=44
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
SBP, Week 20, RRH, n=39
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
SBP, Week 20, RRL, n=39
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
SBP, Week 21, RRH, n=41
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
10
Not reported
Not reported
Not reported
Not reported
SBP, Week 21, RRL, n=41
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
SBP, Week 22, RRH, n=34
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
SBP, Week 22, RRL, n=34
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
SBP, Week 23, RRH, n=36
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
SBP, Week 23, RRL, n=36
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
SBP, Week 24, RRH, n=79
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
13
Not reported
Not reported
Not reported
Not reported
SBP, Week 24, RRL, n=79
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
12
Not reported
Not reported
Not reported
Not reported
SBP, Follow-Up Week 1, RRH, n=29
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
SBP, Follow-Up Week 1, RRL, n=29
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
SBP, Follow-Up Week 2, RRH, n=37
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
SBP, Follow-Up Week 2, RRL, n=37
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
SBP, Follow-Up Week 3, RRH, n=39
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
9
Not reported
Not reported
Not reported
Not reported
SBP, Follow-Up Week 3, RRL, n=39
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
SBP, Follow-Up Week 4, RRH, n=67
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
9
Not reported
Not reported
Not reported
Not reported
SBP, Follow-Up Week 4, RRL, n=67
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
14
title
DBP, Week 1, RRH, n=87
categories
measurements
group Id
OG000
value
8
title
DBP, Week 1, RRL, n=87
categories
measurements
group Id
OG000
value
14
title
DBP, Week 2, RRH, n=86
categories
measurements
group Id
OG000
value
8
title
DBP, Week 2, RRL, n=86
categories
measurements
group Id
OG000
value
13
title
DBP, Week 3, RRH, n=86
categories
measurements
group Id
OG000
value
11
title
DBP, Week 3, RRL, n=86
categories
measurements
group Id
OG000
value
10
title
DBP, Week 4, RRH, n=68
categories
measurements
group Id
OG000
value
7
title
DBP, Week 4, RRL, n=68
categories
measurements
group Id
OG000
value
7
title
DBP, Week 5, RRH, n=61
categories
measurements
group Id
OG000
value
7
title
DBP, Week 5, RRL, n=61
categories
measurements
group Id
OG000
value
6
title
DBP, Week 6, RRH, n=55
categories
measurements
group Id
OG000
value
4
title
DBP, Week 6, RRL, n=55
denoms
counts
group Id
OG000
value
87
units
Participants
description
Vital sign measurements were taken before any blood draw and included systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate(HR). The number of participants are reported with vital sign data falling outside the standard RR as reference range high(RRH) and reference range low(RRL) from SCR up to Week 24 of Part 2 and from Follow-up Week 1 to Week 4. RR for Blood Pressure(mmHg) are read as: Lower Limit of Normal, Normal Range, Upper Limit of Normal. For Ages 1 to 5 years (yrs) ranges are SBP \<85, 85 to 115, \>115; DBP \<45, 45 to70, \>70. Ages 6 to 11 yrs: SBP \<85, 85 to 120, \>120; DBP \<50, 50 to 75, \>75. Ages 12 to 17 yrs: SBP \<95, 95 to 135, \>135; DBP \<55, 55 to 85, \>85. RR for HR (bpm) are ages 1 to \< 3 yrs: \<90, 90 to 140, \>140; ages 3 to \< 5 yrs: \<75, 75 to 130, \>130, ages 5 to \< 8yrs: \<65, 65 to 115, \>115; ages 8 to \< 12yrs: \<55, 55 to 110, \>110; and ages 12 to 18 yrs: \<55, 55 to 110, \>110.
groups
description
Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
id
OG000
title
Part 2 (Open-Label Period) - Eltrombopag
param Type
NUMBER
population Description
Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
reporting Status
POSTED
time Frame
From Week 1 up to Week 24 of Part 2 and Follow-up Week 1 to Week 4 (up to Week 41)
title
Number of Participants With Vital Sign Data Falling Outside the Reference Ranges (RR) at the Indicated Visit During Part 2
Triangle