NCT00351468 · OUTCOME
Number of Subjects Who Responded to Eltrombopag in a Previous Study and Who Respond to Retreatment With a Rise in Platelet Count to Either ≥ 50,000/µL or ≥30,000/µL
EXTEND (Eltrombopag Extended Dosing Study) · Source last updated 2017-04-17
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
- Baseline up to 2 years
What was measured
Responder in TRA100773: Platelet count 50 Gi/L and 2 x baseline (BL) at last on-treatment assessment. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline (BL), 50 Gi/L, and 30 Gi/L at any time. Responder in RAISE: Platelet count 50GI/L and 2 x baseline at Week 6 assessment. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline, 50 Gi/L, and 30 Gi/L at any time. Responder in REPEAT: Platelet count 50 GI/L and 2 x baseline (BL) at Week 6 assessment in Cycle 1. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline (BL) 50 Gi/L, and 30 Gi/L at any time.
Analysis population: ITT
Groups in this outcome
Eltrombopag
Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
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 |
|---|
| Eltrombopag | 302 |
|---|
Reported measurements
TRA100773 Responders >= 50 Gi/L in EXTEND, n=51
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Eltrombopag | 49 | Not reported | Not reported | Not reported | Not reported |
|---|
TRA100773 >=50 Gi/L and 2 x BL in EXTEND, n=51
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Eltrombopag | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
TRA100773 Responders >= 30 Gi/L in EXTEND, n=51
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Eltrombopag | 49 | Not reported | Not reported | Not reported | Not reported |
|---|
RAISE Responders >= 50 Gi/L in EXTEND, n=59
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Eltrombopag | 54 | Not reported | Not reported | Not reported | Not reported |
|---|
RAISE >= 50 Gi/L and 2 x BL in EXTEND, n=59
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Eltrombopag | 53 | Not reported | Not reported | Not reported | Not reported |
|---|
RAISE Responders >= 30 Gi/L in EXTEND, n=51
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Eltrombopag | 55 | Not reported | Not reported | Not reported | Not reported |
|---|
REPEAT Responders >= 50 Gi/L in EXTEND, n=36
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Eltrombopag | 33 | Not reported | Not reported | Not reported | Not reported |
|---|
REPEAT>= 50 Gi/L and 2 x BL in EXTEND, n=36
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Eltrombopag | 33 | Not reported | Not reported | Not reported | Not reported |
|---|
REPEAT Responders >= 30 Gi/L in EXTEND, n=36
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Eltrombopag | 35 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- TRA100773 Responders >= 50 Gi/L in EXTEND, n=51
- title
- TRA100773 >=50 Gi/L and 2 x BL in EXTEND, n=51
- title
- TRA100773 Responders >= 30 Gi/L in EXTEND, n=51
- title
- RAISE Responders >= 50 Gi/L in EXTEND, n=59
- title
- RAISE >= 50 Gi/L and 2 x BL in EXTEND, n=59
- title
- RAISE Responders >= 30 Gi/L in EXTEND, n=51
- title
- REPEAT Responders >= 50 Gi/L in EXTEND, n=36
- title
- REPEAT>= 50 Gi/L and 2 x BL in EXTEND, n=36
- title
- REPEAT Responders >= 30 Gi/L in EXTEND, n=36
- description
- Responder in TRA100773: Platelet count 50 Gi/L and 2 x baseline (BL) at last on-treatment assessment. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline (BL), 50 Gi/L, and 30 Gi/L at any time. Responder in RAISE: Platelet count 50GI/L and 2 x baseline at Week 6 assessment. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline, 50 Gi/L, and 30 Gi/L at any time. Responder in REPEAT: Platelet count 50 GI/L and 2 x baseline (BL) at Week 6 assessment in Cycle 1. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline (BL) 50 Gi/L, and 30 Gi/L at any time.
- groups
- description
- Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
- id
- OG000
- title
- Eltrombopag
- param Type
- NUMBER
- population Description
- ITT
- reporting Status
- POSTED
- time Frame
- Baseline up to 2 years
- title
- Number of Subjects Who Responded to Eltrombopag in a Previous Study and Who Respond to Retreatment With a Rise in Platelet Count to Either ≥ 50,000/µL or ≥30,000/µL
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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