TriangleNCT00908037 · OUTCOME
Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1
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, Week 6, Week 12, and Week 24 of Part 1
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, after 12 weeks of treatment and at the end 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 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 1 (Dose-Finding Period) Cohort 1
Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 1 (Dose-Finding Period) Cohort 2
Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of \<27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of \>=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 1 (Dose-Finding Period) Cohort 3
Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, 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 1 (Dose-Finding Period) Cohort 1 | 5 |
| Part 1 (Dose-Finding Period) Cohort 2 | 5 |
| Part 1 (Dose-Finding Period) Cohort 3 | 5 |
Reported measurements
Baseline, n=5, 5, 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose-Finding Period) Cohort 1 | 73.18 | 15.743 | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 2 | 53.95 | 16.534 | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 3 | 74.80 | 17.199 | Not reported | Not reported | Not reported |
Week 6, n=4, 5, 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose-Finding Period) Cohort 1 | 82.84 | 9.131 | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 2 | 61.57 | 13.664 | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 3 | 71.54 | 14.798 | Not reported | Not reported | Not reported |
Week 12, n=4, 4, 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose-Finding Period) Cohort 1 | 84.14 | 11.712 | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 2 | 66.43 | 12.349 | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 3 | 65.58 | 17.887 | Not reported | Not reported | Not reported |
Week 24, n= 3, 4, 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose-Finding Period) Cohort 1 | 76.38 | 20.228 | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 2 | 82.50 | 15.995 | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 3 | 78.87 | 12.056 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 15.743
- value
- 73.18
- group Id
- OG001
- spread
- 16.534
- value
- 53.95
- group Id
- OG002
- spread
- 17.199
- value
- 74.80
- title
- Baseline, n=5, 5, 5
- categories
- measurements
- group Id
- OG000
- spread
- 9.131
- value
- 82.84
- group Id
- OG001
- spread
- 13.664
- value
- 61.57
- group Id
- OG002
- spread
- 14.798
- value
- 71.54
- title
- Week 6, n=4, 5, 5
- categories
- measurements
- group Id
- OG000
- spread
- 11.712
- value
- 84.14
- group Id
- OG001
- spread
- 12.349
- value
- 66.43
- group Id
- OG002
- spread
- 17.887
- value
- 65.58
- title
- Week 12, n=4, 4, 4
- categories
- measurements
- group Id
- OG000
- spread
- 20.228
- value
- 76.38
- group Id
- OG001
- spread
- 15.995
- value
- 82.50
- group Id
- OG002
- spread
- 12.056
- value
- 78.87
- title
- Week 24, n= 3, 4, 3
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 5
- 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, after 12 weeks of treatment and at the end 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 a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
- id
- OG000
- title
- Part 1 (Dose-Finding Period) Cohort 1
- description
- Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of \<27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of \>=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
- id
- OG001
- title
- Part 1 (Dose-Finding Period) Cohort 2
- description
- Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
- id
- OG002
- title
- Part 1 (Dose-Finding Period) Cohort 3
- param Type
- MEAN
- population Description
- ITT Population. Only those participants available at the specified time points were analyzed (represented by n=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, Week 6, Week 12, and Week 24 of Part 1
- title
- Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1
- type
- SECONDARY
- unit Of Measure
- Score on scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice