NCT01520909 · OUTCOME
Percentage of Responders
Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body. · Source last updated 2015-03-10
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- From Week 1 up to Week 12 of Part 1
What was measured
Percentage of participants who responded (defined as platelet count \>= 50 Gi/L in absence of rescue) at least once up to week 12 of Part 1 (Odds of achieving a platelet count \>=50 Gi/L during the first 12 weeks of Part 1)
Analysis population: ITT Population
Groups in this outcome
Part 1 (Randomized Period)-Placebo
In Part 1, participants aged between 6 and 17 years with a body weight \<27 kg received placebo 37.5 mg QD, and those with a body weight \>=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
Part 1 (Randomized Period) - Eltrombopag
In Part 1, participants aged between 6 and 17 years with a body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1 (Randomized Period)-Placebo | 29 |
|---|
| Part 1 (Randomized Period) - Eltrombopag | 63 |
|---|
Reported measurements
Week 1
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 (Randomized Period)-Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 (Randomized Period) - Eltrombopag | 15.9 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 2
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 (Randomized Period)-Placebo | 3.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 (Randomized Period) - Eltrombopag | 23.8 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 3
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 (Randomized Period)-Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 (Randomized Period) - Eltrombopag | 31.7 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 4
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 (Randomized Period)-Placebo | 6.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 (Randomized Period) - Eltrombopag | 36.5 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 5
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 (Randomized Period)-Placebo | 6.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 (Randomized Period) - Eltrombopag | 47.6 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 6
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 (Randomized Period)-Placebo | 6.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 (Randomized Period) - Eltrombopag | 38.1 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 7
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 (Randomized Period)-Placebo | 10.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 (Randomized Period) - Eltrombopag | 44.4 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 8
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 (Randomized Period)-Placebo | 3.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 (Randomized Period) - Eltrombopag | 44.4 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 9
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 (Randomized Period)-Placebo | 3.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 (Randomized Period) - Eltrombopag | 42.9 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 10
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 (Randomized Period)-Placebo | 3.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 (Randomized Period) - Eltrombopag | 52.4 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 11
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 (Randomized Period)-Placebo | 6.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 (Randomized Period) - Eltrombopag | 49.2 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 12
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 (Randomized Period)-Placebo | 3.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 (Randomized Period) - Eltrombopag | 58.7 | Not reported | Not reported | Not reported | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- 8.15
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 78.73
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 25.33
- statistical Comment
- Repeated measures model for binary data using Generalized linear mixed model
- statistical Method
- Repeated measures model for binary data
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 8.15
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 78.73
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 25.33
- statistical Comment
- Repeated measures model for binary data using Generalized linear mixed model
- statistical Method
- Repeated measures model for binary data
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 15.9
- title
- Week 1
- categories
- measurements
- group Id
- OG000
- value
- 3.4
- group Id
- OG001
- value
- 23.8
- title
- Week 2
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 31.7
- title
- Week 3
- categories
- measurements
- group Id
- OG000
- value
- 6.9
- group Id
- OG001
- value
- 36.5
- title
- Week 4
- categories
- measurements
- group Id
- OG000
- value
- 6.9
- group Id
- OG001
- value
- 47.6
- title
- Week 5
- categories
- measurements
- group Id
- OG000
- value
- 6.9
- group Id
- OG001
- value
- 38.1
- title
- Week 6
- categories
- measurements
- group Id
- OG000
- value
- 10.3
- group Id
- OG001
- value
- 44.4
- title
- Week 7
- categories
- measurements
- group Id
- OG000
- value
- 3.4
- group Id
- OG001
- value
- 44.4
- title
- Week 8
- categories
- measurements
- group Id
- OG000
- value
- 3.4
- group Id
- OG001
- value
- 42.9
- title
- Week 9
- categories
- measurements
- group Id
- OG000
- value
- 3.4
- group Id
- OG001
- value
- 52.4
- title
- Week 10
- categories
- measurements
- group Id
- OG000
- value
- 6.9
- group Id
- OG001
- value
- 49.2
- title
- Week 11
- categories
- measurements
- group Id
- OG000
- value
- 3.4
- group Id
- OG001
- value
- 58.7
- title
- Week 12
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 63
- units
- Participants
- description
- Percentage of participants who responded (defined as platelet count \>= 50 Gi/L in absence of rescue) at least once up to week 12 of Part 1 (Odds of achieving a platelet count \>=50 Gi/L during the first 12 weeks of Part 1)
- groups
- description
- In Part 1, participants aged between 6 and 17 years with a body weight \<27 kg received placebo 37.5 mg QD, and those with a body weight \>=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
- id
- OG000
- title
- Part 1 (Randomized Period)-Placebo
- description
- In Part 1, participants aged between 6 and 17 years with a body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
- id
- OG001
- title
- Part 1 (Randomized Period) - Eltrombopag
- param Type
- NUMBER
- population Description
- ITT Population
- reporting Status
- POSTED
- time Frame
- From Week 1 up to Week 12 of Part 1
- title
- Percentage of Responders
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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