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NCT03484702 · OUTCOME

Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores

Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma · Source last updated 2024-12-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Scores on a Scale
Interval / dispersion
Standard Deviation
Time frame
At baseline and Day 1, 29, 60, 90, 180, 270, 365, 545, and 730 post JCAR017 infusion.

What was measured

The EORTC QLQ-C30 consists of five functional scales (physical, role, emotional, cognitive, social), three symptom scales (fatigue, nausea/vomiting, pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). The questionnaire is scored on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much. The raw score is the average of the items contributing to the scale. The final scores are calculated via linear transformation of raw scores and range from 0 to 100. For functional scales higher scores indicate better QoL. For symptom scales and single items lower scores indicate fewer symptoms, i.e. better QoL. Baseline the last available recorded scores on or prior to the date of JCAR017 infusion. Only global health, fatigue, physical and cognitive functioning subscales were assessed.

Analysis population: All participants in the JCAR017-treated set with completed baseline questionnaires and with at least one completed post-baseline questionnaire.

Groups in this outcome

Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy

JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).

Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy

JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).

Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2

JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).

Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma

JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).

Cohort 5: Primary Central Nervous System Lymphoma

JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).

Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting

JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy34
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy23
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 210
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma5
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9

Reported measurements

Global Health Status: Change from baseline Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy34
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy23
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 210
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma5
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy-4.4117.070Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy-5.0717.898Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-6.6710.244Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma-8.33NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma8.3325.685Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-7.4112.108Not reportedNot reportedNot reported
Global Health Status: Change from baseline Day 29

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy33
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy19
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 210
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma4
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy-1.2614.301Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy0.0018.002Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-4.1717.236Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0.00NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma16.6711.785Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-1.8514.299Not reportedNot reportedNot reported
Global Health Status: Change from baseline Day 60

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy30
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy17
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 26
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy5.0014.778Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy7.8417.547Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 24.1716.457Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0.00NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma13.8926.788Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9.268.784Not reportedNot reportedNot reported
Global Health Status: Change from baseline Day 90

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy27
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy13
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 27
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy2.4714.766Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy1.2822.527Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-5.9517.817Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0.00NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma22.2241.107Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting4.638.448Not reportedNot reportedNot reported
Global Health Status: Change from baseline Day 180

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy12
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy8
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 27
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting6
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy6.9413.685Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy1.0423.332Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-13.1035.635Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma-16.67NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma25.0022.048Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting2.788.607Not reportedNot reportedNot reported
Global Health Status: Change from baseline Day 270

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy12
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy6
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 25
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting5
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy6.2520.140Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy9.729.742Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-3.3326.745Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0.00NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma25.0022.048Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting3.339.501Not reportedNot reportedNot reported
Global Health Status: Change from baseline Day 365

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy10
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy7
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 24
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting5
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy-6.6720.337Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy3.5711.664Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-12.5025.909Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0.00NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma30.5626.788Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting3.337.454Not reportedNot reportedNot reported
Global Health Status: Change from baseline Day 545

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy9
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy7
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 23
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma2
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting5
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy-6.4818.530Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy3.5726.726Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-5.5624.056Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0.00NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma0.0047.140Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting1.679.129Not reportedNot reportedNot reported
Global Health Status: Change from baseline Day 730

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy12
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy6
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 24
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma2
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting4
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy-11.1112.975Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy-4.1712.638Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-6.257.979Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0.00NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma20.8329.463Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-2.0821.916Not reportedNot reportedNot reported
Physical Functioning: Change from baseline Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy34
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy23
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 210
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma5
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy-3.3320.970Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy-6.0921.074Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-3.3311.440Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma-6.67NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma-2.6719.777Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-3.7014.948Not reportedNot reportedNot reported
Physical Functioning: Change from baseline Day 29

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy33
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy19
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 210
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma5
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy-2.6318.555Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy-4.2110.706Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-10.0014.824Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma6.67NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma-8.3316.667Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-8.1518.493Not reportedNot reportedNot reported
Physical Functioning: Change from baseline Day 60

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy30
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy17
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 26
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy3.1115.135Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy-0.3921.275Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-4.4415.587Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0.00NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma-2.2210.184Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-2.9610.062Not reportedNot reportedNot reported
Physical Functioning: Change from baseline Day 90

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy27
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy13
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 27
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy3.4616.781Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy3.5912.054Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-5.7111.174Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma6.67NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma11.1123.413Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-0.7418.692Not reportedNot reportedNot reported
Physical Functioning: Change from baseline Day 180

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy12
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy8
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 27
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting6
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy7.7812.975Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy-8.3331.219Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-5.7119.024Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma-6.67NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma15.5627.756Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-2.2224.825Not reportedNot reportedNot reported
Physical Functioning: Change from baseline Day 270

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy12
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy6
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 25
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting5
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy3.3310.050Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy1.1119.052Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-2.6722.410Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma6.67NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma24.4427.756Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-6.6731.972Not reportedNot reportedNot reported
Physical Functioning: Change from baseline Day 365

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy10
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy7
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 24
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting5
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy0.6716.163Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy0.9516.069Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-16.6720.000Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma6.67NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma22.2226.943Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting5.3311.926Not reportedNot reportedNot reported
Physical Functioning: Change from baseline Day 545

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy9
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy7
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 23
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma2
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting5
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy-3.7026.690Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy-1.9019.135Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-13.3323.094Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma6.67NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma13.3347.140Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9.3311.155Not reportedNot reportedNot reported
Physical Functioning: Change from baseline Day 730

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy12
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy6
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 24
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma2
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting4
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy1.1115.785Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy-8.8928.493Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-3.338.607Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma6.67NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma3.3342.426Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-3.3311.547Not reportedNot reportedNot reported
Cognitive Functioning: Change from baseline Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy34
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy23
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 210
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma5
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy-3.4317.301Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy-3.6217.376Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-1.679.461Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0.00NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma-3.3313.944Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-1.8510.015Not reportedNot reportedNot reported
Cognitive Functioning: Change from baseline Day 29

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy33
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy19
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 210
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma4
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy-2.5316.203Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy3.5114.250Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 23.3313.147Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0.00NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma8.3321.517Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-7.4112.108Not reportedNot reportedNot reported
Cognitive Functioning: Change from baseline Day 60

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy30
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy17
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 26
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy2.7812.444Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy0.9810.978Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 20.0027.889Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0.00NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma33.3344.096Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-1.8513.029Not reportedNot reportedNot reported
Cognitive Functioning: Change from baseline Day 90

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy27
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy13
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 27
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy0.0013.074Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy-1.2812.659Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 24.7620.893Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0.00NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma11.1119.245Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting0.008.333Not reportedNot reportedNot reported
Cognitive Functioning: Change from baseline Day 180

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy12
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy8
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 27
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting6
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy-2.7815.624Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy-2.085.893Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 211.9020.893Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0.00NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma16.6728.868Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-5.568.607Not reportedNot reportedNot reported
Cognitive Functioning: Change from baseline Day 270

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy12
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy6
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 25
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting5
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy0.0022.473Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy0.000.000Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 23.3313.944Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0.00NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma33.3344.096Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting3.337.454Not reportedNot reportedNot reported
Cognitive Functioning: Change from baseline Day 365

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy10
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy7
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 24
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting5
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy-11.6722.292Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy0.000.000Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-4.178.333Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0.00NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma22.2238.490Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting6.679.129Not reportedNot reportedNot reported
Cognitive Functioning: Change from baseline Day 545

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy9
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy7
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 23
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma2
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting5
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy-7.4118.840Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy2.3811.501Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-5.5619.245Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0.00NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma-41.6782.496Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting3.337.454Not reportedNot reportedNot reported
Cognitive Functioning: Change from baseline Day 730

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy12
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy6
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 24
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma2
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting4
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy-1.3918.060Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy-5.568.607Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-4.1715.957Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0.00NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma-16.6723.570Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-4.178.333Not reportedNot reportedNot reported
Fatigue: Change from baseline Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy34
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy23
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 210
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma5
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy1.6326.959Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy1.4516.173Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 23.3320.320Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0.00NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma-20.0030.832Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting1.2318.794Not reportedNot reportedNot reported
Fatigue: Change from baseline Day 29

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy33
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy19
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 210
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma4
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy3.0324.418Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy2.3412.046Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 25.5617.568Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma-11.11NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma-13.8927.778Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting6.1714.815Not reportedNot reportedNot reported
Fatigue: Change from baseline Day 60

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy30
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy17
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 26
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy-9.6318.623Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy-1.3120.743Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 23.7031.946Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma11.11NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma-14.8135.717Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting0.0017.568Not reportedNot reportedNot reported
Fatigue: Change from baseline Day 90

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy27
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy13
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 27
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy-4.5319.795Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy-4.2717.881Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 24.7635.635Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma-11.11NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma-37.0412.830Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-3.7022.906Not reportedNot reportedNot reported
Fatigue: Change from baseline Day 180

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy12
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy8
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 27
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting6
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy-8.3321.254Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy2.7834.503Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-4.7638.946Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma22.22NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma-37.0423.130Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting0.0033.702Not reportedNot reportedNot reported
Fatigue: Change from baseline Day 270

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy12
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy6
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 25
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting5
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy-9.2615.594Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy0.0022.222Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-6.6714.907Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma-11.11NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma-29.6342.066Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-2.2234.605Not reportedNot reportedNot reported
Fatigue: Change from baseline Day 365

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy10
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy7
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 24
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma3
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting5
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy-3.3314.861Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy-4.7620.141Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 213.8933.179Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma-11.11NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma-44.4422.222Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-13.3314.487Not reportedNot reportedNot reported
Fatigue: Change from baseline Day 545

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy9
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy7
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 23
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma2
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting5
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy4.9425.526Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy-1.5919.698Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2-3.7027.962Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma-11.11NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma-5.5623.570Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-11.1115.713Not reportedNot reportedNot reported
Fatigue: Change from baseline Day 730

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy12
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy6
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 24
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma2
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting4
Values in Scores on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy0.9322.947Not reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy3.709.072Not reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 25.5614.344Not reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma-11.11NANot reportedNot reportedInsufficient number of participants to calculate standard deviation.
Cohort 5: Primary Central Nervous System Lymphoma-16.677.857Not reportedNot reportedNot reported
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting-8.3316.667Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.070
        value
        -4.41
      2. group Id
        OG001
        spread
        17.898
        value
        -5.07
      3. group Id
        OG002
        spread
        10.244
        value
        -6.67
      4. comment
        Insufficient number of participants to calculate standard deviation.
        group Id
        OG003
        spread
        NA
        value
        -8.33
      5. group Id
        OG004
        spread
        25.685
        value
        8.33
      6. group Id
        OG005
        spread
        12.108
        value
        -7.41
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        23
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        9
      units
      Participants
    title
    Global Health Status: Change from baseline Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.301
        value
        -1.26
      2. group Id
        OG001
        spread
        18.002
        value
        0.00
      3. group Id
        OG002
        spread
        17.236
        value
        -4.17
      4. comment
        Insufficient number of participants to calculate standard deviation.
        group Id
        OG003
        spread
        NA
        value
        0.00
      5. group Id
        OG004
        spread
        11.785
        value
        16.67
      6. group Id
        OG005
        spread
        14.299
        value
        -1.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        9
      units
      Participants
    title
    Global Health Status: Change from baseline Day 29
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.778
        value
        5.00
      2. group Id
        OG001
        spread
        17.547
        value
        7.84
      3. group Id
        OG002
        spread
        16.457
        value
        4.17
      4. comment
        Insufficient number of participants to calculate standard deviation.
        group Id
        OG003
        spread
        NA
        value
        0.00
      5. group Id
        OG004
        spread
        26.788
        value
        13.89
      6. group Id
        OG005
        spread
        8.784
        value
        9.26
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        17
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        9
      units
      Participants
    title
    Global Health Status: Change from baseline Day 60
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.766
        value
        2.47
      2. group Id
        OG001
        spread
        22.527
        value
        1.28
      3. group Id
        OG002
        spread
        17.817
        value
        -5.95
      4. comment
        Insufficient number of participants to calculate standard deviation.
        group Id
        OG003
        spread
        NA
        value
        0.00
      5. group Id
        OG004
        spread
        41.107
        value
        22.22
      6. group Id
        OG005
        spread
        8.448
        value
        4.63
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        9
      units
      Participants
    title
    Global Health Status: Change from baseline Day 90
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.685
        value
        6.94
      2. group Id
        OG001
        spread
        23.332
        value
        1.04
      3. group Id
        OG002
        spread
        35.635
        value
        -13.10
      4. comment
        Insufficient number of participants to calculate standard deviation.
        group Id
        OG003
        spread
        NA
        value
        -16.67
      5. group Id
        OG004
        spread
        22.048
        value
        25.00
      6. group Id
        OG005
        spread
        8.607
        value
        2.78
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        6
      units
      Participants
    title
    Global Health Status: Change from baseline Day 180
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.140
        value
        6.25
      2. group Id
        OG001
        spread
        9.742
        value
        9.72
      3. group Id
        OG002
        spread
        26.745
        value
        -3.33
      4. comment
        Insufficient number of participants to calculate standard deviation.
        group Id
        OG003
        spread
        NA
        value
        0.00
      5. group Id
        OG004
        spread
        22.048
        value
        25.00
      6. group Id
        OG005
        spread
        9.501
        value
        3.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        5
      units
      Participants
    title
    Global Health Status: Change from baseline Day 270
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.337
        value
        -6.67
      2. group Id
        OG001
        spread
        11.664
        value
        3.57
      3. group Id
        OG002
        spread
        25.909
        value
        -12.50
      4. comment
        Insufficient number of participants to calculate standard deviation.
        group Id
        OG003
        spread
        NA
        value
        0.00
      5. group Id
        OG004
        spread
        26.788
        value
        30.56
      6. group Id
        OG005
        spread
        7.454
        value
        3.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        5
      units
      Participants
    title
    Global Health Status: Change from baseline Day 365
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.530
        value
        -6.48
      2. group Id
        OG001
        spread
        26.726
        value
        3.57
      3. group Id
        OG002
        spread
        24.056
        value
        -5.56
      4. comment
        Insufficient number of participants to calculate standard deviation.
        group Id
        OG003
        spread
        NA
        value
        0.00
      5. group Id
        OG004
        spread
        47.140
        value
        0.00
      6. group Id
        OG005
        spread
        9.129
        value
        1.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        5
      units
      Participants
    title
    Global Health Status: Change from baseline Day 545
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.975
        value
        -11.11
      2. group Id
        OG001
        spread
        12.638
        value
        -4.17
      3. group Id
        OG002
        spread
        7.979
        value
        -6.25
      4. comment
        Insufficient number of participants to calculate standard deviation.
        group Id
        OG003
        spread
        NA
        value
        0.00
      5. group Id
        OG004
        spread
        29.463
        value
        20.83
      6. group Id
        OG005
        spread
        21.916
        value
        -2.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        4
      units
      Participants
    title
    Global Health Status: Change from baseline Day 730
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.970
        value
        -3.33
      2. group Id
        OG001
        spread
        21.074
        value
        -6.09
      3. group Id
        OG002
        spread
        11.440
        value
        -3.33
      4. comment
        Insufficient number of participants to calculate standard deviation.
        group Id
        OG003
        spread
        NA
        value
        -6.67
      5. group Id
        OG004
        spread
        19.777
        value
        -2.67
      6. group Id
        OG005
        spread
        14.948
        value
        -3.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        23
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        9
      units
      Participants
    title
    Physical Functioning: Change from baseline Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.555
        value
        -2.63
      2. group Id
        OG001
        spread
        10.706
        value
        -4.21
      3. group Id
        OG002
        spread
        14.824
        value
        -10.00
      4. comment
        Insufficient number of participants to calculate standard deviation.
        group Id
        OG003
        spread
        NA
        value
        6.67
      5. group Id
        OG004
        spread
        16.667
        value
        -8.33
      6. group Id
        OG005
        spread
        18.493
        value
        -8.15
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        9
      units
      Participants
    title
    Physical Functioning: Change from baseline Day 29
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.135
        value
        3.11
      2. group Id
        OG001
        spread
        21.275
        value
        -0.39
      3. group Id
        OG002
        spread
        15.587
        value
        -4.44
      4. comment
        Insufficient number of participants to calculate standard deviation.
        group Id
        OG003
        spread
        NA
        value
        0.00
      5. group Id
        OG004
        spread
        10.184
        value
        -2.22
      6. group Id
        OG005
        spread
        10.062
        value
        -2.96
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        17
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        9
      units
      Participants
    title
    Physical Functioning: Change from baseline Day 60
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    2. group Id
      OG001
      value
      23
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      5
    6. group Id
      OG005
      value
      9
    units
    Participants
description
The EORTC QLQ-C30 consists of five functional scales (physical, role, emotional, cognitive, social), three symptom scales (fatigue, nausea/vomiting, pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). The questionnaire is scored on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much. The raw score is the average of the items contributing to the scale. The final scores are calculated via linear transformation of raw scores and range from 0 to 100. For functional scales higher scores indicate better QoL. For symptom scales and single items lower scores indicate fewer symptoms, i.e. better QoL. Baseline the last available recorded scores on or prior to the date of JCAR017 infusion. Only global health, fatigue, physical and cognitive functioning subscales were assessed.
dispersion Type
Standard Deviation
groups
  1. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    OG000
    title
    Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
  2. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    OG001
    title
    Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
  3. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    OG002
    title
    Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
  4. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    OG003
    title
    Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
  5. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    OG004
    title
    Cohort 5: Primary Central Nervous System Lymphoma
  6. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    OG005
    title
    Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
param Type
MEAN
population Description
All participants in the JCAR017-treated set with completed baseline questionnaires and with at least one completed post-baseline questionnaire.
reporting Status
POSTED
time Frame
At baseline and Day 1, 29, 60, 90, 180, 270, 365, 545, and 730 post JCAR017 infusion.
title
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores
type
SECONDARY
unit Of Measure
Scores on a Scale

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Preserved source evidence · Not medical advice