TriangleNCT00908037 · OUTCOME
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2
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
- From Baseline and post-Baseline up to Study Week 7 of Part 2
What was measured
Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The nmber of participants with positive finding at Baseline and at anytime post-Baseline (Post-BL) were reported. Baseline was defined as the value obtained at the first visit before treatment (Pre-trt). A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts.
Analysis population: Safety Population, only those participants enrolled during Part 2 were analyzed.
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 | 17 |
| Part 2 (Randomized Period) Cohort 3-Placebo | 4 |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 11 |
Reported measurements
Pre-trt Epithelial Renal Tubular Cell Casts
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3-Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 0 | Not reported | Not reported | Not reported | Not reported |
Pre-trt RBC Casts
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3-Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 0 | Not reported | Not reported | Not reported | Not reported |
Pre-trt WBC Casts
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3-Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 0 | Not reported | Not reported | Not reported | Not reported |
Post-BL Epithelial Renal Tubular Cell Casts
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3-Placebo | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 0 | Not reported | Not reported | Not reported | Not reported |
Post-BL RBC Casts
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3-Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 0 | Not reported | Not reported | Not reported | Not reported |
Post-BL WBC Casts
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) Cohort 1-Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 1- Eltrombopag | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 2-Eltrombopag | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3-Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) Cohort 3- Eltrombopag | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Pre-trt Epithelial Renal Tubular Cell Casts
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Pre-trt RBC Casts
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Pre-trt WBC Casts
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- title
- Post-BL Epithelial Renal Tubular Cell Casts
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Post-BL RBC Casts
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- title
- Post-BL WBC Casts
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 17
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 11
- units
- Participants
- description
- Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The nmber of participants with positive finding at Baseline and at anytime post-Baseline (Post-BL) were reported. Baseline was defined as the value obtained at the first visit before treatment (Pre-trt). A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts.
- 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
- NUMBER
- population Description
- Safety Population, only those participants enrolled during Part 2 were analyzed.
- reporting Status
- POSTED
- time Frame
- From Baseline and post-Baseline up to Study Week 7 of Part 2
- title
- Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice