TriangleNCT00567567 · OUTCOME
Response After Induction Therapy
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Proportion participants that responded
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Study enrollment to the end of induction therapy
What was measured
Per the International Response Criteria: measurable tumor defined as product of longest x widest perpendicular diameter. Elevated catecholamine levels, tumor cell invasion of bone marrow also considered measurable tumor. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)-\>90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; \>50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by \>50%. Mixed Response (MR)-\>50% reduction of any measurable lesion (primary or metastases) with \<50% reduction in other sites; no new lesions; \<25% increase in any existing lesion. No Response (NR)-no new lesions; \<50% reduction but \<25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by \>25%; previous negative marrow positive.
Analysis population: Eligible patients evaluated for response at the end of induction therapy.
Groups in this outcome
Single HST (CEM)
Induction therapy + single myeloablative consolidation
Tandem HST (CEM), Randomly Assigned
Induction therapy + tandem myeloablative consolidation
Not Assigned
Patients that either failed during Induction therapy or refused randomization
| Group | Source count |
|---|---|
| Single HST (CEM) | 206 |
| Tandem HST (CEM), Randomly Assigned | 176 |
| Not Assigned | 233 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Single HST (CEM) | 0.54 | Not reported | 0.47 | 0.61 | Not reported |
| Tandem HST (CEM), Randomly Assigned | 0.48 | Not reported | 0.41 | 0.56 | Not reported |
| Not Assigned | 0.35 | Not reported | 0.29 | 0.41 | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- group Description
- Chi-square test of proportions in all patients to compare the proportion of responders (complete response \[CR\]+ very good partial response \[VGPR\]) at the end of induction therapy in this study to an analogous cohort of responders in A3973.
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0034
- param Type
- Chi-squared test statistic
- param Value
- 8.5751
- statistical Method
- Chi-squared
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- group Description
- Chi-square test of proportions in all patients to compare the proportion of responders (complete response \[CR\]+ very good partial response \[VGPR\]) at the end of induction therapy in this study to an analogous cohort of responders in A3973.
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0034
- param Type
- Chi-squared test statistic
- param Value
- 8.5751
- statistical Method
- Chi-squared
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.47
- upper Limit
- 0.61
- value
- 0.54
- group Id
- OG001
- lower Limit
- 0.41
- upper Limit
- 0.56
- value
- 0.48
- group Id
- OG002
- lower Limit
- 0.29
- upper Limit
- 0.41
- value
- 0.35
- denoms
- counts
- group Id
- OG000
- value
- 206
- group Id
- OG001
- value
- 176
- group Id
- OG002
- value
- 233
- units
- Participants
- description
- Per the International Response Criteria: measurable tumor defined as product of longest x widest perpendicular diameter. Elevated catecholamine levels, tumor cell invasion of bone marrow also considered measurable tumor. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)-\>90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; \>50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by \>50%. Mixed Response (MR)-\>50% reduction of any measurable lesion (primary or metastases) with \<50% reduction in other sites; no new lesions; \<25% increase in any existing lesion. No Response (NR)-no new lesions; \<50% reduction but \<25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by \>25%; previous negative marrow positive.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Induction therapy + single myeloablative consolidation
- id
- OG000
- title
- Single HST (CEM)
- description
- Induction therapy + tandem myeloablative consolidation
- id
- OG001
- title
- Tandem HST (CEM), Randomly Assigned
- description
- Patients that either failed during Induction therapy or refused randomization
- id
- OG002
- title
- Not Assigned
- param Type
- NUMBER
- population Description
- Eligible patients evaluated for response at the end of induction therapy.
- reporting Status
- POSTED
- time Frame
- Study enrollment to the end of induction therapy
- title
- Response After Induction Therapy
- type
- PRIMARY
- unit Of Measure
- Proportion participants that responded
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Preserved source evidence · Not medical advice