TriangleNCT00908037 · OUTCOME
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Beats per minute
- Interval / dispersion
- Standard Deviation
- Time frame
- From Week 1 to Week 7 of Part 2
What was measured
Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment.
Analysis population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Groups in this outcome
Part 2 (Randomized Period) Cohort 1-Placebo
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
| Group | Source count |
|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | 8 |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | 16 |
| Part 2 (Randomized Period) Cohort 2-Placebo | 9 |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | 17 |
| Part 2 (Randomized Period) Cohort 3-Placebo | 4 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 11 |
Reported measurements
Screening, n=8, 16, 9, 15
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | 80.1 | 10.11 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | 82.8 | 17.28 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Placebo | 86.9 | 16.10 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | 94.3 | 17.53 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3-Placebo | 91.5 | 6.56 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 101.5 | 23.48 | Not reported | Not reported | Not reported |
Day 1, n=6, 14, 9, 13
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | 77.2 | 12.32 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | 81.3 | 8.70 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Placebo | 93.0 | 14.04 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | 88.8 | 12.84 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3-Placebo | 98.7 | 5.69 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 99.6 | 15.84 | Not reported | Not reported | Not reported |
Week 1, n=8, 16, 9, 17
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | 76.4 | 8.50 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | 80.1 | 12.04 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Placebo | 89.9 | 18.48 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | 98.4 | 19.76 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3-Placebo | 98.5 | 13.44 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 96.4 | 17.08 | Not reported | Not reported | Not reported |
Week 2, n=7, 15, 9, 17
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | 79.4 | 8.75 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | 81.7 | 9.79 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Placebo | 89.0 | 12.44 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | 91.8 | 16.96 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3-Placebo | 95.3 | 7.09 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 102.5 | 11.81 | Not reported | Not reported | Not reported |
Week 3, n=8, 16, 9, 16
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | 81.5 | 12.21 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | 84.0 | 10.93 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Placebo | 86.6 | 13.39 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | 95.8 | 13.57 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3-Placebo | 97.0 | 14.67 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 102.6 | 17.44 | Not reported | Not reported | Not reported |
Week 4, n=8, 16, 9, 16
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | 76.3 | 6.96 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | 82.4 | 10.39 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Placebo | 84.4 | 15.91 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | 91.5 | 14.45 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3-Placebo | 93.5 | 17.00 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 116.1 | 23.26 | Not reported | Not reported | Not reported |
Week 5, n=8, 16, 9, 16
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | 79.3 | 9.44 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | 82.5 | 13.87 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Placebo | 95.3 | 14.96 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | 92.4 | 15.18 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3-Placebo | 89.0 | 15.52 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 99.8 | 19.51 | Not reported | Not reported | Not reported |
Week 6, n=8, 16, 9, 17
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | 77.0 | 9.50 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | 83.2 | 11.01 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Placebo | 86.8 | 11.62 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | 90.1 | 17.74 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3-Placebo | 84.8 | 13.15 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 103.0 | 23.14 | Not reported | Not reported | Not reported |
Week 7, n=8, 16, 9, 17
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | 74.1 | 6.92 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | 82.8 | 11.68 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Placebo | 96.7 | 15.39 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | 91.6 | 17.68 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3-Placebo | 101.5 | 16.60 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 105.3 | 15.18 | Not reported | Not reported | Not reported |
MBP, n=8, 16, 9, 17
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | 88.3 | 7.72 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | 97.6 | 7.51 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Placebo | 106.1 | 11.92 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | 108.6 | 17.08 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3-Placebo | 106.8 | 12.28 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 117.5 | 21.68 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 10.11
- value
- 80.1
- group Id
- OG001
- spread
- 17.28
- value
- 82.8
- group Id
- OG002
- spread
- 16.10
- value
- 86.9
- group Id
- OG003
- spread
- 17.53
- value
- 94.3
- group Id
- OG004
- spread
- 6.56
- value
- 91.5
- group Id
- OG005
- spread
- 23.48
- value
- 101.5
- title
- Screening, n=8, 16, 9, 15
- categories
- measurements
- group Id
- OG000
- spread
- 12.32
- value
- 77.2
- group Id
- OG001
- spread
- 8.70
- value
- 81.3
- group Id
- OG002
- spread
- 14.04
- value
- 93.0
- group Id
- OG003
- spread
- 12.84
- value
- 88.8
- group Id
- OG004
- spread
- 5.69
- value
- 98.7
- group Id
- OG005
- spread
- 15.84
- value
- 99.6
- title
- Day 1, n=6, 14, 9, 13
- categories
- measurements
- group Id
- OG000
- spread
- 8.50
- value
- 76.4
- group Id
- OG001
- spread
- 12.04
- value
- 80.1
- group Id
- OG002
- spread
- 18.48
- value
- 89.9
- group Id
- OG003
- spread
- 19.76
- value
- 98.4
- group Id
- OG004
- spread
- 13.44
- value
- 98.5
- group Id
- OG005
- spread
- 17.08
- value
- 96.4
- title
- Week 1, n=8, 16, 9, 17
- categories
- measurements
- group Id
- OG000
- spread
- 8.75
- value
- 79.4
- group Id
- OG001
- spread
- 9.79
- value
- 81.7
- group Id
- OG002
- spread
- 12.44
- value
- 89.0
- group Id
- OG003
- spread
- 16.96
- value
- 91.8
- group Id
- OG004
- spread
- 7.09
- value
- 95.3
- group Id
- OG005
- spread
- 11.81
- value
- 102.5
- title
- Week 2, n=7, 15, 9, 17
- categories
- measurements
- group Id
- OG000
- spread
- 12.21
- value
- 81.5
- group Id
- OG001
- spread
- 10.93
- value
- 84.0
- group Id
- OG002
- spread
- 13.39
- value
- 86.6
- group Id
- OG003
- spread
- 13.57
- value
- 95.8
- group Id
- OG004
- spread
- 14.67
- value
- 97.0
- group Id
- OG005
- spread
- 17.44
- value
- 102.6
- title
- Week 3, n=8, 16, 9, 16
- categories
- measurements
- group Id
- OG000
- spread
- 6.96
- value
- 76.3
- group Id
- OG001
- spread
- 10.39
- value
- 82.4
- group Id
- OG002
- spread
- 15.91
- value
- 84.4
- group Id
- OG003
- spread
- 14.45
- value
- 91.5
- group Id
- OG004
- spread
- 17.00
- value
- 93.5
- group Id
- OG005
- spread
- 23.26
- value
- 116.1
- title
- Week 4, n=8, 16, 9, 16
- categories
- measurements
- group Id
- OG000
- spread
- 9.44
- value
- 79.3
- group Id
- OG001
- spread
- 13.87
- value
- 82.5
- group Id
- OG002
- spread
- 14.96
- value
- 95.3
- group Id
- OG003
- spread
- 15.18
- value
- 92.4
- group Id
- OG004
- spread
- 15.52
- value
- 89.0
- group Id
- OG005
- spread
- 19.51
- value
- 99.8
- title
- Week 5, n=8, 16, 9, 16
- categories
- measurements
- group Id
- OG000
- spread
- 9.50
- value
- 77.0
- group Id
- OG001
- spread
- 11.01
- value
- 83.2
- group Id
- OG002
- spread
- 11.62
- value
- 86.8
- group Id
- OG003
- spread
- 17.74
- value
- 90.1
- group Id
- OG004
- spread
- 13.15
- value
- 84.8
- group Id
- OG005
- spread
- 23.14
- value
- 103.0
- title
- Week 6, n=8, 16, 9, 17
- categories
- measurements
- group Id
- OG000
- spread
- 6.92
- value
- 74.1
- group Id
- OG001
- spread
- 11.68
- value
- 82.8
- group Id
- OG002
- spread
- 15.39
- value
- 96.7
- group Id
- OG003
- spread
- 17.68
- value
- 91.6
- group Id
- OG004
- spread
- 16.60
- value
- 101.5
- group Id
- OG005
- spread
- 15.18
- value
- 105.3
- title
- Week 7, n=8, 16, 9, 17
- categories
- measurements
- group Id
- OG000
- spread
- 7.72
- value
- 88.3
- group Id
- OG001
- spread
- 7.51
- value
- 97.6
- group Id
- OG002
- spread
- 11.92
- value
- 106.1
- group Id
- OG003
- spread
- 17.08
- value
- 108.6
- group Id
- OG004
- spread
- 12.28
- value
- 106.8
- group Id
- OG005
- spread
- 21.68
- value
- 117.5
- title
- MBP, n=8, 16, 9, 17
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 17
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 11
- units
- Participants
- description
- Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
- id
- OG000
- title
- Part 2 (Randomized Period) Cohort 1-Placebo
- description
- Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
- id
- OG001
- title
- Part 2 (Randomized Period) Cohort 1- Eltrombopag
- description
- Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
- id
- OG002
- title
- Part 2 (Randomized Period) Cohort 2-Placebo
- description
- Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
- id
- OG003
- title
- Part 2 (Randomized Period) Cohort 2-Eltrombopag
- description
- Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
- id
- OG004
- title
- Part 2 (Randomized Period) Cohort 3-Placebo
- description
- Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
- id
- OG005
- title
- Part 2 (Randomized Period) Cohort 3- Eltrombopag
- param Type
- MEAN
- population Description
- Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
- reporting Status
- POSTED
- time Frame
- From Week 1 to Week 7 of Part 2
- title
- Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2
- type
- SECONDARY
- unit Of Measure
- Beats per minute
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Preserved source evidence · Not medical advice