NCT01520909 · OUTCOME

Number of Participants With Vital Sign Data Falling Outside the Reference Ranges (RR) at the Indicated Visit During Part 1

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 Screening (SCR) up to Week 13 of Part 1

What was measured

Vital sign measurements were taken before any blood draws 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 reference ranges RR as reference range high(RRH) and reference range low(RRL). The Baseline(BL) value is defined as the value taken at Day 1 or if missing, the latest non-missing SCR value. 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 available at the specified time points were analyzed (represented by n=X,X in the category titles).

Groups in this outcome

Part 1 (Randomized Period)-Placebo

In Part 1, participants aged between 6 and 17 years with a body weight \<27 kg received placebo 37.5 mg QD, and those with a body weight \>=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.

Part 1 (Randomized Period)-Eltrombopag

In Part 1, participants 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; 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 1 (Randomized Period)-Placebo	29
Part 1 (Randomized Period)-Eltrombopag	63

Reported measurements

DBP, Day 1, RRH, n=28,62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	6	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	8	Not reported	Not reported	Not reported	Not reported

DBP, Day 1, RRL, n=28, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	2	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	5	Not reported	Not reported	Not reported	Not reported

DBP, Week 1, RRH, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	3	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	10	Not reported	Not reported	Not reported	Not reported

DBP, Week 1, RRL, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	0	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	5	Not reported	Not reported	Not reported	Not reported

DBP, Week 2, RRH, n=29, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	3	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	8	Not reported	Not reported	Not reported	Not reported

DBP, Week 2, RRL, n=29, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	2	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	6	Not reported	Not reported	Not reported	Not reported

DBP, Week 3, RRH, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	7	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	12	Not reported	Not reported	Not reported	Not reported

DBP, Week 3, RRL, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	2	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	6	Not reported	Not reported	Not reported	Not reported

DBP, Week 4, RRH, n=29, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	7	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	5	Not reported	Not reported	Not reported	Not reported

DBP, Week 4, RRL, n=29, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	2	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	9	Not reported	Not reported	Not reported	Not reported

DBP, Week 5, RRH, n=27, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	4	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	10	Not reported	Not reported	Not reported	Not reported

DBP, Week 5, RRL, n=27, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	2	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	6	Not reported	Not reported	Not reported	Not reported

DBP, Week 6, RRH, n=28, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	7	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	10	Not reported	Not reported	Not reported	Not reported

DBP, Week 6, RRL, n=28, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	1	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	8	Not reported	Not reported	Not reported	Not reported

DBP, Week 7, RRH, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	3	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	7	Not reported	Not reported	Not reported	Not reported

DBP, Week 7, RRL, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	2	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	5	Not reported	Not reported	Not reported	Not reported

DBP, Week 8, RRH, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	4	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	9	Not reported	Not reported	Not reported	Not reported

DBP, Week 8, RRL, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	2	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	8	Not reported	Not reported	Not reported	Not reported

DBP, Week 9, RRH, n=27, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	4	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	9	Not reported	Not reported	Not reported	Not reported

DBP, Week 9, RRL, n=27, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	2	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	4	Not reported	Not reported	Not reported	Not reported

DBP, Week 10, RRH, n=28, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	6	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	8	Not reported	Not reported	Not reported	Not reported

DBP, Week 10, RRL, n=28, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	2	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	7	Not reported	Not reported	Not reported	Not reported

DBP, Week 11, RRH, n=28, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	6	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	8	Not reported	Not reported	Not reported	Not reported

DBP, Week 11, RRL, n=28, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	3	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	6	Not reported	Not reported	Not reported	Not reported

DBP, Week 12, RRH, n=28, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	3	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	8	Not reported	Not reported	Not reported	Not reported

DBP, Week 12, RRL, n=28, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	0	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	6	Not reported	Not reported	Not reported	Not reported

DBP, Week 13, RRH, n=28, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	4	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	9	Not reported	Not reported	Not reported	Not reported

DBP, Week 13, RRL, n=28, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	3	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	4	Not reported	Not reported	Not reported	Not reported

Heart Rate, Day 1, RRH, n=28, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	0	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	2	Not reported	Not reported	Not reported	Not reported

Heart Rate, Day 1, RRL, n=28, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	0	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	1	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 1, RRH, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	0	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	0	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 1, RRL, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	0	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	0	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 2, RRH, n=29, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	2	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	1	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 2, RRL, n=29, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	0	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	1	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 3, RRH, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	1	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	2	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 3, RRL, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	0	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	0	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 4, RRH, n=29, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	0	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	4	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 4, RRL, n=29, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	0	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	1	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 5, RRH, n=27, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	1	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	5	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 5, RRL, n=27, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	1	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	0	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 6, RRH, n=28,62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	1	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	1	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 6, RRL, n=28, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	1	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	0	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 7, RRH, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	0	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	2	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 7, RRL, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	1	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	0	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 8, RRH, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	1	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	2	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 8, RRL, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	1	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	0	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 9, RRH, n=27, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	1	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	2	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 9, RRL, n=27, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	0	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	0	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 10, RRH, n=28, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	1	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	1	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 10, RRL, n=28, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	0	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	0	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 11, RRH, n=28, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	1	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	2	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 11, RRL, n=28, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	0	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	0	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 12, RRH, n=28,61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	0	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	2	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 12, RRL, n=28, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	0	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	0	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 13, RRH, n=28, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	0	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	3	Not reported	Not reported	Not reported	Not reported

Heart Rate, Week 13, RRL, n=28, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	1	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	0	Not reported	Not reported	Not reported	Not reported

SBP, Day 1, RRH, n=28, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	5	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	10	Not reported	Not reported	Not reported	Not reported

SBP, Day 1, RRL, n=28, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	3	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	6	Not reported	Not reported	Not reported	Not reported

SBP, Week 1, RRH, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	3	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	11	Not reported	Not reported	Not reported	Not reported

SBP, Week 1, RRL, n=28,63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	4	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	8	Not reported	Not reported	Not reported	Not reported

SBP, Week 2, RRH, n=29, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	4	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	7	Not reported	Not reported	Not reported	Not reported

SBP, Week 2, RRL, n=29, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	3	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	9	Not reported	Not reported	Not reported	Not reported

SBP, Week 3, RRH, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	3	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	9	Not reported	Not reported	Not reported	Not reported

SBP, Week 3, RRL, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	2	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	9	Not reported	Not reported	Not reported	Not reported

SBP, Week 4, RRH, n=29, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	3	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	10	Not reported	Not reported	Not reported	Not reported

SBP, Week 4, RRL, n=29, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	2	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	9	Not reported	Not reported	Not reported	Not reported

SBP, Week 5, RRH, n=27, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	5	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	9	Not reported	Not reported	Not reported	Not reported

SBP, Week 5, RRL, n=27, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	4	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	7	Not reported	Not reported	Not reported	Not reported

SBP, Week 6, RRH, n=28, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	5	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	7	Not reported	Not reported	Not reported	Not reported

SBP, Week 6, RRL, n=28, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	3	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	8	Not reported	Not reported	Not reported	Not reported

SBP, Week 7, RRH, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	5	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	10	Not reported	Not reported	Not reported	Not reported

SBP, Week 7, RRL, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	3	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	7	Not reported	Not reported	Not reported	Not reported

SBP, Week 8, RRH, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	3	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	14	Not reported	Not reported	Not reported	Not reported

SBP, Week 8, RRL, n=28, 63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	4	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	7	Not reported	Not reported	Not reported	Not reported

SBP, Week 9, RRH, n=27, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	4	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	12	Not reported	Not reported	Not reported	Not reported

SBP, Week 9, RRL, n=27, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	3	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	7	Not reported	Not reported	Not reported	Not reported

SBP, Week 10, RRH, n=28, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	4	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	11	Not reported	Not reported	Not reported	Not reported

SBP, Week 10, RRL, n=28, 62

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	3	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	11	Not reported	Not reported	Not reported	Not reported

SBP, Week 11, RRH, n=28, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	6	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	12	Not reported	Not reported	Not reported	Not reported

SBP, Week 11, RRL, n=28, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	5	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	9	Not reported	Not reported	Not reported	Not reported

SBP, Week 12, RRH, n=28, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	4	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	11	Not reported	Not reported	Not reported	Not reported

SBP, Week 12, RRL, n=28, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	4	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	4	Not reported	Not reported	Not reported	Not reported

SBP, Week 13, RRH, n=28, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	6	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	9	Not reported	Not reported	Not reported	Not reported

SBP, Week 13, RRL, n=28, 61

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1 (Randomized Period)-Placebo	4	Not reported	Not reported	Not reported	Not reported
Part 1 (Randomized Period)-Eltrombopag	7	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
6
group Id
OG001
value
8
title
DBP, Day 1, RRH, n=28,62
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
5
title
DBP, Day 1, RRL, n=28, 62
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
10
title
DBP, Week 1, RRH, n=28, 63
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
5
title
DBP, Week 1, RRL, n=28, 63
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
8
title
DBP, Week 2, RRH, n=29, 63
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
6
title
DBP, Week 2, RRL, n=29, 63
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
12
title
DBP, Week 3, RRH, n=28, 63
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
6
title
DBP, Week 3, RRL, n=28, 63
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
5
title
DBP, Week 4, RRH, n=29, 62
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
9
title
DBP, Week 4, RRL, n=29, 62
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
10
title
DBP, Week 5, RRH, n=27, 62
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
6
title
DBP, Week 5, RRL, n=27, 62

denoms

counts
group Id
OG000
value
29
group Id
OG001
value
63
units
Participants

description

groups

description
In Part 1, participants aged between 6 and 17 years with a body weight \<27 kg received placebo 37.5 mg QD, and those with a body weight \>=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
id
OG000
title
Part 1 (Randomized Period)-Placebo
description
In Part 1, participants 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; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
id
OG001
title
Part 1 (Randomized Period)-Eltrombopag

param Type

NUMBER

population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).

reporting Status

POSTED

time Frame

From Screening (SCR) up to Week 13 of Part 1

title

Number of Participants With Vital Sign Data Falling Outside the Reference Ranges (RR) at the Indicated Visit During Part 1

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice