NCT00072475 · OUTCOME
Number of Participants With Response
Vatalanib in Treating Patients With Primary or Secondary Myelodysplastic Syndromes · Source last updated 2016-08-01
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
- Duration of study (up to 5 years)
What was measured
Response was measured by International Standardized Response Criteria for MDS
* Complete Response: Bone marrow showing \< 5% myeloblasts with normal maturation of all cell lines; Hgb \> 11 g/dL (untransfused), ANC ≥1.5 K/L, PLT ≥ 100 K/L, No blasts, no dysplasia
* Partial remission: All of the CR criteria (if abnormal at baseline), except BM evaluation. Blasts decreased by ≥ 50% over baseline. Cellularity and morphology are not relevant.
Hematologic improvement:
* Erythroid (HI-E): For participants with baseline HGB \< 11g/dL, Major: \> 2g/dL increase, transfusion independence. Minor: 1-2g/dL increase, ≥ 50% decrease in transfusion requirements
* Platelet (HI-P): For participants with baseline PLT \< 100 K/L: Major: absolute increase of \> 30 K/L, transfusion independence. Minor: ≥ 50% increase (net increase of \>10 K/L)
* Neutrophil (HI-N): For participants with baseline ANC \< 1.5 K/L, Major: \> 100% increase (net increase \> 0.5 K/L). Minor: \> 100% increase (absolute increase \< 0.5 K/L)
Groups in this outcome
Vatalanib
Adult patients with MDS receive treatment with vatalanib.
vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or \> tox (1st increase=1000mg/day; 2nd increase 1250 mg/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 |
|---|
| Vatalanib | 142 |
|---|
Reported measurements
Complete Remission
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Vatalanib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Partial Remission
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Vatalanib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
HI-E Major
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Vatalanib | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
HI-E Minor
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Vatalanib | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
HI-P Major
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Vatalanib | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
HI-P Minor
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Vatalanib | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
HI-N Major
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Vatalanib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
HI-N Minor
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Vatalanib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Complete Remission
- title
- Partial Remission
- title
- HI-E Major
- title
- HI-E Minor
- title
- HI-P Major
- title
- HI-P Minor
- title
- HI-N Major
- title
- HI-N Minor
- description
- Response was measured by International Standardized Response Criteria for MDS
* Complete Response: Bone marrow showing \< 5% myeloblasts with normal maturation of all cell lines; Hgb \> 11 g/dL (untransfused), ANC ≥1.5 K/L, PLT ≥ 100 K/L, No blasts, no dysplasia
* Partial remission: All of the CR criteria (if abnormal at baseline), except BM evaluation. Blasts decreased by ≥ 50% over baseline. Cellularity and morphology are not relevant.
Hematologic improvement:
* Erythroid (HI-E): For participants with baseline HGB \< 11g/dL, Major: \> 2g/dL increase, transfusion independence. Minor: 1-2g/dL increase, ≥ 50% decrease in transfusion requirements
* Platelet (HI-P): For participants with baseline PLT \< 100 K/L: Major: absolute increase of \> 30 K/L, transfusion independence. Minor: ≥ 50% increase (net increase of \>10 K/L)
* Neutrophil (HI-N): For participants with baseline ANC \< 1.5 K/L, Major: \> 100% increase (net increase \> 0.5 K/L). Minor: \> 100% increase (absolute increase \< 0.5 K/L)
- groups
- description
- Adult patients with MDS receive treatment with vatalanib.
vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or \> tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)
- id
- OG000
- title
- Vatalanib
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Duration of study (up to 5 years)
- title
- Number of Participants With Response
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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