NCT03493451 · OUTCOME
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score
Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms · Source last updated 2024-10-26
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 on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week)
What was measured
Mean change from baseline at safety follow-up visit in EORTC QLQ-C30 Fatigue score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients and includes questions related to fatigue symptoms in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Answers are converted to a score of 0 to 100, with a higher score indicating improved health status.
Analysis population: Safety analysis set includes all participants who received at least one dose of study drug. The number analyzed represents participants who completed the questionnaire.
Groups in this outcome
Cohort 1: ENKTL
Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Cohort 2: PTCL-NOS, AITL, and ALCL
Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Cohort 3: MF and SS
Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
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 |
|---|
| Cohort 1: ENKTL | 22 |
|---|
| Cohort 2: PTCL-NOS, AITL, and ALCL | 44 |
|---|
| Cohort 3: MF and SS | 11 |
|---|
Reported measurements
Cycle 5, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: ENKTL | 12 |
|---|
| Cohort 2: PTCL-NOS, AITL, and ALCL | 19 |
|---|
| Cohort 3: MF and SS | 8 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: ENKTL | -2.78 | 14.312 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: PTCL-NOS, AITL, and ALCL | 7.02 | 14.912 | Not reported | Not reported | Not reported |
|---|
| Cohort 3: MF and SS | 1.39 | 41.335 | Not reported | Not reported | Not reported |
|---|
Cycle 9, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: ENKTL | 6 |
|---|
| Cohort 2: PTCL-NOS, AITL, and ALCL | 8 |
|---|
| Cohort 3: MF and SS | 6 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: ENKTL | 0.00 | 12.172 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: PTCL-NOS, AITL, and ALCL | -1.39 | 11.011 | Not reported | Not reported | Not reported |
|---|
| Cohort 3: MF and SS | -22.22 | 41.574 | Not reported | Not reported | Not reported |
|---|
Cycle 13, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: ENKTL | 7 |
|---|
| Cohort 2: PTCL-NOS, AITL, and ALCL | 5 |
|---|
| Cohort 3: MF and SS | 6 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: ENKTL | -1.59 | 11.878 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: PTCL-NOS, AITL, and ALCL | -6.67 | 12.669 | Not reported | Not reported | Not reported |
|---|
| Cohort 3: MF and SS | -5.56 | 18.257 | Not reported | Not reported | Not reported |
|---|
Cycle 17, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: ENKTL | 6 |
|---|
| Cohort 2: PTCL-NOS, AITL, and ALCL | 6 |
|---|
| Cohort 3: MF and SS | 6 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: ENKTL | 9.26 | 16.355 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: PTCL-NOS, AITL, and ALCL | 1.85 | 10.924 | Not reported | Not reported | Not reported |
|---|
| Cohort 3: MF and SS | -12.96 | 16.355 | Not reported | Not reported | Not reported |
|---|
Cycle 21, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: ENKTL | 4 |
|---|
| Cohort 2: PTCL-NOS, AITL, and ALCL | 3 |
|---|
| Cohort 3: MF and SS | 4 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: ENKTL | 0.00 | 12.830 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: PTCL-NOS, AITL, and ALCL | 11.11 | 11.111 | Not reported | Not reported | Not reported |
|---|
| Cohort 3: MF and SS | -16.67 | 14.344 | Not reported | Not reported | Not reported |
|---|
Cycle 25, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: ENKTL | 4 |
|---|
| Cohort 2: PTCL-NOS, AITL, and ALCL | 2 |
|---|
| Cohort 3: MF and SS | 2 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: ENKTL | 0.00 | 15.713 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: PTCL-NOS, AITL, and ALCL | 27.78 | 7.857 | Not reported | Not reported | Not reported |
|---|
| Cohort 3: MF and SS | -5.56 | 7.857 | Not reported | Not reported | Not reported |
|---|
Cycle 29, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: ENKTL | 3 |
|---|
| Cohort 2: PTCL-NOS, AITL, and ALCL | 2 |
|---|
| Cohort 3: MF and SS | 0 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: ENKTL | 3.70 | 27.962 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: PTCL-NOS, AITL, and ALCL | 22.22 | 15.713 | Not reported | Not reported | Not reported |
|---|
Cycle 33, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: ENKTL | 1 |
|---|
| Cohort 2: PTCL-NOS, AITL, and ALCL | 1 |
|---|
| Cohort 3: MF and SS | 0 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: ENKTL | 11.11 | NA | Not reported | Not reported | Not estimable due to sample size |
|---|
| Cohort 2: PTCL-NOS, AITL, and ALCL | 33.33 | NA | Not reported | Not reported | Not estimable due to sample size |
|---|
Safety Follow-up
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: ENKTL | 14 |
|---|
| Cohort 2: PTCL-NOS, AITL, and ALCL | 24 |
|---|
| Cohort 3: MF and SS | 2 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: ENKTL | -1.59 | 19.903 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: PTCL-NOS, AITL, and ALCL | 7.87 | 30.820 | Not reported | Not reported | Not reported |
|---|
| Cohort 3: MF and SS | -44.44 | 31.427 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 14.312
- value
- -2.78
- group Id
- OG001
- spread
- 14.912
- value
- 7.02
- group Id
- OG002
- spread
- 41.335
- value
- 1.39
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 8
- units
- Participants
- title
- Cycle 5, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 12.172
- value
- 0.00
- group Id
- OG001
- spread
- 11.011
- value
- -1.39
- group Id
- OG002
- spread
- 41.574
- value
- -22.22
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 6
- units
- Participants
- title
- Cycle 9, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 11.878
- value
- -1.59
- group Id
- OG001
- spread
- 12.669
- value
- -6.67
- group Id
- OG002
- spread
- 18.257
- value
- -5.56
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 6
- units
- Participants
- title
- Cycle 13, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 16.355
- value
- 9.26
- group Id
- OG001
- spread
- 10.924
- value
- 1.85
- group Id
- OG002
- spread
- 16.355
- value
- -12.96
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- units
- Participants
- title
- Cycle 17, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 12.830
- value
- 0.00
- group Id
- OG001
- spread
- 11.111
- value
- 11.11
- group Id
- OG002
- spread
- 14.344
- value
- -16.67
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- units
- Participants
- title
- Cycle 21, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 15.713
- value
- 0.00
- group Id
- OG001
- spread
- 7.857
- value
- 27.78
- group Id
- OG002
- spread
- 7.857
- value
- -5.56
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- units
- Participants
- title
- Cycle 25, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 27.962
- value
- 3.70
- group Id
- OG001
- spread
- 15.713
- value
- 22.22
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Cycle 29, Day 1
- categories
- measurements
- comment
- Not estimable due to sample size
- group Id
- OG000
- spread
- NA
- value
- 11.11
- comment
- Not estimable due to sample size
- group Id
- OG001
- spread
- NA
- value
- 33.33
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Cycle 33, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 19.903
- value
- -1.59
- group Id
- OG001
- spread
- 30.820
- value
- 7.87
- group Id
- OG002
- spread
- 31.427
- value
- -44.44
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 2
- units
- Participants
- title
- Safety Follow-up
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 44
- group Id
- OG002
- value
- 11
- units
- Participants
- description
- Mean change from baseline at safety follow-up visit in EORTC QLQ-C30 Fatigue score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients and includes questions related to fatigue symptoms in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Answers are converted to a score of 0 to 100, with a higher score indicating improved health status.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
- id
- OG000
- title
- Cohort 1: ENKTL
- description
- Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
- id
- OG001
- title
- Cohort 2: PTCL-NOS, AITL, and ALCL
- description
- Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
- id
- OG002
- title
- Cohort 3: MF and SS
- param Type
- MEAN
- population Description
- Safety analysis set includes all participants who received at least one dose of study drug. The number analyzed represents participants who completed the questionnaire.
- reporting Status
- POSTED
- time Frame
- Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week)
- title
- Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score
- type
- SECONDARY
- unit Of Measure
- Score on a scale
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