TriangleNCT00908037 · OUTCOME
Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3
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
- From Baseline to end of treatment up to Study Week 31
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 2/3 (Eltrombopag Period) Cohort 1
All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2/3 (Eltrombopag Period) Cohort 2
All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of \<=27 kg received 25 mg QD and participants with a body weight of \>=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2/3 (Eltrombopag Period) Cohort 3
All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
| Group | Source count |
|---|---|
| Part 2/3 (Eltrombopag Period) Cohort 1 | 24 |
| Part 2/3 (Eltrombopag Period) Cohort 2 | 28 |
| Part 2/3 (Eltrombopag Period) Cohort 3 | 15 |
Reported measurements
Baseline, n=17, 18, 10
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2/3 (Eltrombopag Period) Cohort 1 | 79.34 | 13.315 | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Period) Cohort 2 | 70.59 | 16.237 | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Period) Cohort 3 | 79.10 | 9.016 | Not reported | Not reported | Not reported |
Week 6, n=11, 13, 9
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2/3 (Eltrombopag Period) Cohort 1 | 79.46 | 13.899 | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Period) Cohort 2 | 80.16 | 13.776 | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Period) Cohort 3 | 80.85 | 15.082 | Not reported | Not reported | Not reported |
Week 12, n=9, 7, 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2/3 (Eltrombopag Period) Cohort 1 | 84.25 | 7.531 | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Period) Cohort 2 | 76.48 | 19.948 | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Period) Cohort 3 | 88.10 | 11.166 | Not reported | Not reported | Not reported |
Week 24, n=17, 11, 8
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2/3 (Eltrombopag Period) Cohort 1 | 82.16 | 16.926 | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Period) Cohort 2 | 83.93 | 13.327 | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Period) Cohort 3 | 77.93 | 22.971 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 13.315
- value
- 79.34
- group Id
- OG001
- spread
- 16.237
- value
- 70.59
- group Id
- OG002
- spread
- 9.016
- value
- 79.10
- title
- Baseline, n=17, 18, 10
- categories
- measurements
- group Id
- OG000
- spread
- 13.899
- value
- 79.46
- group Id
- OG001
- spread
- 13.776
- value
- 80.16
- group Id
- OG002
- spread
- 15.082
- value
- 80.85
- title
- Week 6, n=11, 13, 9
- categories
- measurements
- group Id
- OG000
- spread
- 7.531
- value
- 84.25
- group Id
- OG001
- spread
- 19.948
- value
- 76.48
- group Id
- OG002
- spread
- 11.166
- value
- 88.10
- title
- Week 12, n=9, 7, 2
- categories
- measurements
- group Id
- OG000
- spread
- 16.926
- value
- 82.16
- group Id
- OG001
- spread
- 13.327
- value
- 83.93
- group Id
- OG002
- spread
- 22.971
- value
- 77.93
- title
- Week 24, n=17, 11, 8
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 15
- 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
- All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. 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 2/3 (Eltrombopag Period) Cohort 1
- description
- All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of \<=27 kg received 25 mg QD and participants with a body weight of \>=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. 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 2/3 (Eltrombopag Period) Cohort 2
- description
- All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
- id
- OG002
- title
- Part 2/3 (Eltrombopag 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
- From Baseline to end of treatment up to Study Week 31
- title
- Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3
- type
- SECONDARY
- unit Of Measure
- Score on scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice