TriangleNCT00908037 · OUTCOME
Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire 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
- Score on scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and Week 6 of Part 2
What was measured
The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 - Q26 (excluding any answer that is 'Not applicable'). The code list used for the individual question scores is: 1 = never, 2 = seldom, 3 = sometimes, 4 = often, 5 = always and 9 = not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.
Analysis population: ITT 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 | 19 |
| Part 2 (Randomized Period) Cohort 3-Placebo | 5 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 10 |
Reported measurements
Baseline, n=6, 11, 9, 10, 2, 8
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | 83.94 | 8.674 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | 76.84 | 15.049 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Placebo | 71.05 | 19.581 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | 66.36 | 17.321 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3-Placebo | 82.61 | 7.686 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 78.23 | 9.575 | Not reported | Not reported | Not reported |
Week 6, n= 8,11,7,13, 5, 9
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | 79.46 | 10.971 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | 79.46 | 13.899 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Placebo | 74.65 | 20.968 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | 80.16 | 13.776 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3-Placebo | 88.01 | 3.333 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 80.85 | 15.082 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 8.674
- value
- 83.94
- group Id
- OG001
- spread
- 15.049
- value
- 76.84
- group Id
- OG002
- spread
- 19.581
- value
- 71.05
- group Id
- OG003
- spread
- 17.321
- value
- 66.36
- group Id
- OG004
- spread
- 7.686
- value
- 82.61
- group Id
- OG005
- spread
- 9.575
- value
- 78.23
- title
- Baseline, n=6, 11, 9, 10, 2, 8
- categories
- measurements
- group Id
- OG000
- spread
- 10.971
- value
- 79.46
- group Id
- OG001
- spread
- 13.899
- value
- 79.46
- group Id
- OG002
- spread
- 20.968
- value
- 74.65
- group Id
- OG003
- spread
- 13.776
- value
- 80.16
- group Id
- OG004
- spread
- 3.333
- value
- 88.01
- group Id
- OG005
- spread
- 15.082
- value
- 80.85
- title
- Week 6, n= 8,11,7,13, 5, 9
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 10
- units
- Participants
- description
- The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 - Q26 (excluding any answer that is 'Not applicable'). The code list used for the individual question scores is: 1 = never, 2 = seldom, 3 = sometimes, 4 = often, 5 = always and 9 = not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.
- 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
- ITT 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
- Baseline and Week 6 of Part 2
- title
- Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2
- type
- SECONDARY
- unit Of Measure
- Score on scale
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Preserved source evidence · Not medical advice