NCT01482962 · OUTCOME
Change Form Baseline in Reported Symptoms and Quality of Life (QoL) Assessment Per Functional Assessment of Cancer Therapy-Lymphoma (FACT-LYM) for Functioning and Symptoms
Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma · Source last updated 2018-07-31
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and End of Treatment (EOT) (Up to 152 Weeks)
What was measured
The FACT-LYM includes the Functional Assessment of Cancer Therapy General Scale (FACT-G) and a 15-item lymphoma-specific subscale (LYM) over the past week. The FACT-G has 27 items that incorporate 4 scales including physical well-being (PWB; 7 items), social/family well-being (SWB, 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). The combined FACT-LYM instrument consists of a total of a 42 item questionnaire. Each question is answered on a 5- point scale of 0 (not at all) to 4 (very much) for a total possible score of 168. Higher scores indicate better well-being and a positive change from Baseline indicates improvement.
Analysis population: ITT population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing.
Groups in this outcome
Alisertib
Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).
Pralatrexate, or Romidepsin, or Gemcitabine
Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
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 |
|---|
| Alisertib | 138 |
|---|
| Pralatrexate, or Romidepsin, or Gemcitabine | 133 |
|---|
Reported measurements
Physical Well-Being, EOT
Analysis denominator · Participants
| Group | Source count |
|---|
| Alisertib | 81 |
|---|
| Pralatrexate, or Romidepsin, or Gemcitabine | 70 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alisertib | -2.4 | 6.21 | Not reported | Not reported | Not reported |
|---|
| Pralatrexate, or Romidepsin, or Gemcitabine | -1.3 | 5.27 | Not reported | Not reported | Not reported |
|---|
Social/Family Well-Being, EOT
Analysis denominator · Participants
| Group | Source count |
|---|
| Alisertib | 81 |
|---|
| Pralatrexate, or Romidepsin, or Gemcitabine | 69 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alisertib | -0.3 | 4.50 | Not reported | Not reported | Not reported |
|---|
| Pralatrexate, or Romidepsin, or Gemcitabine | 0.0 | 4.44 | Not reported | Not reported | Not reported |
|---|
Emotional Well-Being, EOT
Analysis denominator · Participants
| Group | Source count |
|---|
| Alisertib | 80 |
|---|
| Pralatrexate, or Romidepsin, or Gemcitabine | 67 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alisertib | -1.4 | 4.59 | Not reported | Not reported | Not reported |
|---|
| Pralatrexate, or Romidepsin, or Gemcitabine | -0.8 | 3.93 | Not reported | Not reported | Not reported |
|---|
Functional Well-Being, EOT
Analysis denominator · Participants
| Group | Source count |
|---|
| Alisertib | 80 |
|---|
| Pralatrexate, or Romidepsin, or Gemcitabine | 66 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alisertib | -2.4 | 5.40 | Not reported | Not reported | Not reported |
|---|
| Pralatrexate, or Romidepsin, or Gemcitabine | -0.3 | 4.79 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 6.21
- value
- -2.4
- group Id
- OG001
- spread
- 5.27
- value
- -1.3
- denoms
- counts
- group Id
- OG000
- value
- 81
- group Id
- OG001
- value
- 70
- units
- Participants
- title
- Physical Well-Being, EOT
- categories
- measurements
- group Id
- OG000
- spread
- 4.50
- value
- -0.3
- group Id
- OG001
- spread
- 4.44
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 81
- group Id
- OG001
- value
- 69
- units
- Participants
- title
- Social/Family Well-Being, EOT
- categories
- measurements
- group Id
- OG000
- spread
- 4.59
- value
- -1.4
- group Id
- OG001
- spread
- 3.93
- value
- -0.8
- denoms
- counts
- group Id
- OG000
- value
- 80
- group Id
- OG001
- value
- 67
- units
- Participants
- title
- Emotional Well-Being, EOT
- categories
- measurements
- group Id
- OG000
- spread
- 5.40
- value
- -2.4
- group Id
- OG001
- spread
- 4.79
- value
- -0.3
- denoms
- counts
- group Id
- OG000
- value
- 80
- group Id
- OG001
- value
- 66
- units
- Participants
- title
- Functional Well-Being, EOT
- denoms
- counts
- group Id
- OG000
- value
- 138
- group Id
- OG001
- value
- 133
- units
- Participants
- description
- The FACT-LYM includes the Functional Assessment of Cancer Therapy General Scale (FACT-G) and a 15-item lymphoma-specific subscale (LYM) over the past week. The FACT-G has 27 items that incorporate 4 scales including physical well-being (PWB; 7 items), social/family well-being (SWB, 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). The combined FACT-LYM instrument consists of a total of a 42 item questionnaire. Each question is answered on a 5- point scale of 0 (not at all) to 4 (very much) for a total possible score of 168. Higher scores indicate better well-being and a positive change from Baseline indicates improvement.
- dispersion Type
- Standard Deviation
- groups
- description
- Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).
- id
- OG000
- title
- Alisertib
- description
- Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
- id
- OG001
- title
- Pralatrexate, or Romidepsin, or Gemcitabine
- param Type
- MEAN
- population Description
- ITT population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing.
- reporting Status
- POSTED
- time Frame
- Baseline and End of Treatment (EOT) (Up to 152 Weeks)
- title
- Change Form Baseline in Reported Symptoms and Quality of Life (QoL) Assessment Per Functional Assessment of Cancer Therapy-Lymphoma (FACT-LYM) for Functioning and Symptoms
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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