TriangleNCT00908037 · OUTCOME
Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
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
- Post-Baseline from Week 1 through Follow-up up to Study Week 35
What was measured
Renal parameters included: creatinine (RR: 44.2 - 88.4 umol/L), creatinine clearance derived (RR: 89.0 - 165.0 milliliter per minute \[ ml/min\]), protein/creatinine (RR: 0.113- 18.0992 microgram per millimoles \[mg/mmol\]), and urea (RR: 1.785- 8.925 mmol/L). Baseline values were obtained at Day 1. The number of participants with the indicated renal parameters data outside the reference range (with high and low) any time post-Baseline are presented. Anytime post-Baseline assesments 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 Safety Population.
Groups in this outcome
Part 1 (Dose-Finding Period)
Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 24 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight \<27 kg: 25 mg QD, Weight \>=27 kg: 50 mg QD; east Asian ancestry subjects Weight \<27 kg: 12.5 mg QD, Weight \>=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
Part 2 (Randomized Period) -Placebo
Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3- 1 to 5 years) received eltrombopag matching placebo for 7 weeks.
Part 2 (Randomized Period) - Eltrombopag
Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 7 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight \<27 kg: 25 mg QD, Weight \>=27 kg: 50 mg QD; east Asian ancestry subjects Weight \<27 kg: 12.5 mg QD, Weight \>=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
Part 2/ 3 (Eltrombopag Open-Label Period)
Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
| Group | Source count |
|---|---|
| Part 1 (Dose-Finding Period) | 15 |
| Part 2 (Randomized Period) -Placebo | 21 |
| Part 2 (Randomized Period) - Eltrombopag | 44 |
| Part 2/ 3 (Eltrombopag Open-Label Period) | 65 |
Reported measurements
Creatinine, high, n=15, 21, 44, 65
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose-Finding Period) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) -Placebo | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) - Eltrombopag | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 2/ 3 (Eltrombopag Open-Label Period) | 13 | Not reported | Not reported | Not reported | Not reported |
Creatinine, low, n=15, 21, 44, 65
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose-Finding Period) | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) -Placebo | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) - Eltrombopag | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 2/ 3 (Eltrombopag Open-Label Period) | 12 | Not reported | Not reported | Not reported | Not reported |
Creatinine Clearance Derived, high, n=15, 21,44,65
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose-Finding Period) | 11 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) -Placebo | 17 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) - Eltrombopag | 28 | Not reported | Not reported | Not reported | Not reported |
| Part 2/ 3 (Eltrombopag Open-Label Period) | 46 | Not reported | Not reported | Not reported | Not reported |
Creatinine Clearance Derived, low, n=15, 21,44,65
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose-Finding Period) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) -Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) - Eltrombopag | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 2/ 3 (Eltrombopag Open-Label Period) | 4 | Not reported | Not reported | Not reported | Not reported |
Protein/Creatinine, high, n=12, 19, 38, 58
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose-Finding Period) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) -Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) - Eltrombopag | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 2/ 3 (Eltrombopag Open-Label Period) | 18 | Not reported | Not reported | Not reported | Not reported |
Protein/Creatinine, low, n=12, 19, 38, 58
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose-Finding Period) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) -Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) - Eltrombopag | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2/ 3 (Eltrombopag Open-Label Period) | 0 | Not reported | Not reported | Not reported | Not reported |
Urea, high, n=15, 21, 44, 65
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose-Finding Period) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) -Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) - Eltrombopag | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2/ 3 (Eltrombopag Open-Label Period) | 5 | Not reported | Not reported | Not reported | Not reported |
Urea, low, n=15, 21, 44, 65
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose-Finding Period) | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) -Placebo | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) - Eltrombopag | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 2/ 3 (Eltrombopag Open-Label Period) | 11 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 13
- title
- Creatinine, high, n=15, 21, 44, 65
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 12
- title
- Creatinine, low, n=15, 21, 44, 65
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 28
- group Id
- OG003
- value
- 46
- title
- Creatinine Clearance Derived, high, n=15, 21,44,65
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- title
- Creatinine Clearance Derived, low, n=15, 21,44,65
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 18
- title
- Protein/Creatinine, high, n=12, 19, 38, 58
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Protein/Creatinine, low, n=12, 19, 38, 58
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 5
- title
- Urea, high, n=15, 21, 44, 65
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 11
- title
- Urea, low, n=15, 21, 44, 65
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 44
- group Id
- OG003
- value
- 65
- units
- Participants
- description
- Renal parameters included: creatinine (RR: 44.2 - 88.4 umol/L), creatinine clearance derived (RR: 89.0 - 165.0 milliliter per minute \[ ml/min\]), protein/creatinine (RR: 0.113- 18.0992 microgram per millimoles \[mg/mmol\]), and urea (RR: 1.785- 8.925 mmol/L). Baseline values were obtained at Day 1. The number of participants with the indicated renal parameters data outside the reference range (with high and low) any time post-Baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-baseline assessment
- groups
- description
- Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 24 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight \<27 kg: 25 mg QD, Weight \>=27 kg: 50 mg QD; east Asian ancestry subjects Weight \<27 kg: 12.5 mg QD, Weight \>=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
- id
- OG000
- title
- Part 1 (Dose-Finding Period)
- description
- Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3- 1 to 5 years) received eltrombopag matching placebo for 7 weeks.
- id
- OG001
- title
- Part 2 (Randomized Period) -Placebo
- description
- Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 7 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight \<27 kg: 25 mg QD, Weight \>=27 kg: 50 mg QD; east Asian ancestry subjects Weight \<27 kg: 12.5 mg QD, Weight \>=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
- id
- OG002
- title
- Part 2 (Randomized Period) - Eltrombopag
- description
- Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
- id
- OG003
- title
- Part 2/ 3 (Eltrombopag Open-Label Period)
- param Type
- NUMBER
- 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 Safety Population.
- reporting Status
- POSTED
- time Frame
- Post-Baseline from Week 1 through Follow-up up to Study Week 35
- title
- Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice