NCT01466881 · OUTCOME
Aurora Kinase A Expression
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- proportion of positivity
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline
What was measured
To explore the association between pre-treatment aurora kinase A expression in tumor biopsies as measured by fluorescence in situ hybridization (FISH) and objective response rate in patients with PTCL treated with MLN8237
Analysis population: Eligible patients who consented for correlative studies and had Aurora kinase A expression measured.
Groups in this outcome
Non-responders
Eligible patients who received protocol treatment and did not respond to the protocol treatment. Patients for whom response assessment was inadequate were considered non-responders.
Responders
Eligible Patients who received protocol treatment and achieved complete or partial response.
| Group | Source count |
|---|---|
| Non-responders | 19 |
| Responders | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-responders | 0.121 | 0.096 | Not reported | Not reported | Not reported |
| Responders | 0.063 | 0.060 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- group Description
- The null hypothesis is that there is no significant difference in Aurora kinase A expression between responders and non-responders.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.2316
- statistical Comment
- Two-sided alpha level of 0.05
- statistical Method
- Wilcoxon (Mann-Whitney)
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- group Description
- The null hypothesis is that there is no significant difference in Aurora kinase A expression between responders and non-responders.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.2316
- statistical Comment
- Two-sided alpha level of 0.05
- statistical Method
- Wilcoxon (Mann-Whitney)
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.096
- value
- 0.121
- group Id
- OG001
- spread
- 0.060
- value
- 0.063
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- To explore the association between pre-treatment aurora kinase A expression in tumor biopsies as measured by fluorescence in situ hybridization (FISH) and objective response rate in patients with PTCL treated with MLN8237
- dispersion Type
- Standard Deviation
- groups
- description
- Eligible patients who received protocol treatment and did not respond to the protocol treatment. Patients for whom response assessment was inadequate were considered non-responders.
- id
- OG000
- title
- Non-responders
- description
- Eligible Patients who received protocol treatment and achieved complete or partial response.
- id
- OG001
- title
- Responders
- param Type
- MEAN
- population Description
- Eligible patients who consented for correlative studies and had Aurora kinase A expression measured.
- reporting Status
- POSTED
- time Frame
- Baseline
- title
- Aurora Kinase A Expression
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- proportion of positivity
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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