Trial Outcomes & Findings for A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma (NCT NCT03548207)

Last Updated: 2025-07-30

Results Overview

An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

126 participants

Primary outcome timeframe

Day 1 up to 45.2 months

Results posted on

2025-07-30

Participant Flow

As planned, data for Phase 2 participants were reported separately for US population (78 participants) and Japan population (13 participants).

Participant milestones

Participant milestones
Measure	Phase 1b (US Population) Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (US Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received recommended phase 2 dose (RP2D) dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Overall Study STARTED	35	78	13
Overall Study Treated	29	68	9
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	35	78	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1b (US Population) Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (US Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received recommended phase 2 dose (RP2D) dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Overall Study Death	10	23	3
Overall Study Lost to Follow-up	0	2	0
Overall Study Withdrawal by Subject	0	3	0
Overall Study Sponsor decision	19	40	6
Overall Study Randomized but not treated	6	10	4

Baseline Characteristics

A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1b (US Population) n=29 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (US Population) n=68 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received recommended phase 2 dose (RP2D) dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=9 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Total n=106 Participants Total of all reporting groups
Age, Continuous	60.9 Years STANDARD_DEVIATION 6.42 • n=5 Participants	62.5 Years STANDARD_DEVIATION 9.09 • n=7 Participants	58.9 Years STANDARD_DEVIATION 8.87 • n=5 Participants	61.7 Years STANDARD_DEVIATION 8.42 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	25 Participants n=7 Participants	4 Participants n=5 Participants	44 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	43 Participants n=7 Participants	5 Participants n=5 Participants	62 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	12 Participants n=7 Participants	0 Participants n=5 Participants	17 Participants n=4 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	49 Participants n=7 Participants	0 Participants n=5 Participants	69 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants
Region of Enrollment Japan	0 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants
Region of Enrollment United States	29 Participants n=5 Participants	68 Participants n=7 Participants	0 Participants n=5 Participants	97 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 up to 45.2 months

Population: All treated analysis set included all participants who received JNJ-68284528 infusion.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=29 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b: Number of Participants With Adverse Events as Per Severity Grade 1	0 Participants	—	—
Phase 1b: Number of Participants With Adverse Events as Per Severity Grade 2	0 Participants	—	—
Phase 1b: Number of Participants With Adverse Events as Per Severity Grade 3	2 Participants	—	—
Phase 1b: Number of Participants With Adverse Events as Per Severity Grade 4	26 Participants	—	—
Phase 1b: Number of Participants With Adverse Events as Per Severity Grade 5	1 Participants	—	—

PRIMARY outcome

Timeframe: Day 1 up to 45.2 months

Population: Modified intent-to-treat (mITT) analysis set included all participants who received a JNJ-68284528 infusion at the targeted recommended phase 2 dose (RP2D) dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

ORR was defined as the percentage of participants who achieved partial response (PR) or better according to international myeloma working group (IMWG) criteria. IMWG criteria for PR: greater than or equal to (\>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to less than (\<) 200 milligrams (mg) per 24 hours. If the serum and urine M-protein were not measurable, a decrease of \>=50% in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the M-protein criteria. If serum and urine M-protein were not measurable, and serum free light assay was also not measurable, \>=50% reduction in bone marrow plasma cells (PCs) was required in place of M-protein, provided baseline bone marrow PC percentage was \>=30%. In addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas was also required.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=68 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=8 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 2: Overall Response Rate (ORR)	97.1 Percentage of participants Interval 89.8 to 99.6	100.0 Percentage of participants Interval 66.4 to 100.0	—

SECONDARY outcome

Timeframe: Day 1 up to 45.2 months

Population: All treated analysis set included all participants who received JNJ-68284528 infusion.

An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity was graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=68 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=9 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity Grade 1	0 Participants	0 Participants	—
Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity Grade 2	0 Participants	1 Participants	—
Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity Grade 3	5 Participants	0 Participants	—
Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity Grade 4	58 Participants	8 Participants	—
Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity Grade 5	5 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Pre and post dose on Day 1, and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years)

Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.

Maximum observed plasma concentration (Cmax) of JNJ-68284528 transgene was reported. Cmax was calculated in copies per microgram (mcg) genomic deoxyribonucleic acid (DNA).

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=29 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=68 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=9 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-68284528 Transgene	38965 copies per mcg genomic DNA Standard Deviation 19408	52841 copies per mcg genomic DNA Standard Deviation 29021	44077 copies per mcg genomic DNA Standard Deviation 39911

SECONDARY outcome

Timeframe: Pre and post dose on Day 1 and Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years)

Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.

Tlast was defined as actual sampling time of last measurable (non-below quantification limit \[BQL\]) analyte concentration of JNJ-68284528 transgene.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=29 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=68 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=9 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: Actual Sampling Time of Last Measurable Analyte Concentration (Tlast) of JNJ-68284528 Transgene	127.13 Days Interval 26.15 to 715.0	122.98 Days Interval 20.04 to 910.92	129.89 Days Interval 24.97 to 568.92

SECONDARY outcome

Timeframe: Pre and post dose on Day 1; Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100, then every 4 weeks up to 1 year, and at the time of progressive disease or at study completion for participants without progressive disease (up to approximately 2.5 years)

Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.

Area under the plasma concentration versus time curve from time 0 to last measurable concentration of JNJ-68284528 transgene was reported.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=29 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=68 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=9 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 To Last Measurable Concentration (AUC0-last) of JNJ-68284528 Transgene	588162 Day*copies per mcg genomic DNA Standard Deviation 466441	1356191 Day*copies per mcg genomic DNA Standard Deviation 1673474	4062950 Day*copies per mcg genomic DNA Standard Deviation 7293651

SECONDARY outcome

Area under the plasma concentration versus time curve from time 0 to infinite time of JNJ-68284528 transgene was reported.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=11 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=33 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=3 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinite Time (AUC0-infinity) of JNJ-68284528 Transgene	542728 Day*copies per mcg genomic DNA Standard Deviation 345847	1321427 Day*copies per mcg genomic DNA Standard Deviation 1513726	7173538 Day*copies per mcg genomic DNA Standard Deviation 12191640

SECONDARY outcome

Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.

Maximum observed plasma concentration (Cmax) of CD3+CAR+ Cells was reported. Cmax was calculated in cells per microliter.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=29 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=68 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=9 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528	483 Cells per microliter Standard Deviation 464	1472 Cells per microliter Standard Deviation 2085	1614 Cells per microliter Standard Deviation 3718

SECONDARY outcome

Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.

T Cell persistence after a single infusion of JNJ-68284528 was reported. T Cell persistence was defined as actual sampling time of last measurable (non-below quantification limit \[BQL\]) analyte concentration.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=29 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=68 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=9 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: T Cell Persistence After a Single Infusion of JNJ-68284528	84.08 Days Interval 12.89 to 715.0	100.23 Days Interval 20.04 to 910.92	56.81 Days Interval 12.72 to 568.92

SECONDARY outcome

Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.

Area under the plasma concentration versus time curve from time 0 to last measurable concentration of CD3+CAR+ Cells was reported.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=29 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=68 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=9 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 To Last Measurable Concentration (AUC0-last) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528	7758 Day*cells per microliter Standard Deviation 7599	40073 Day*cells per microliter Standard Deviation 79603	152904 Day*cells per microliter Standard Deviation 361949

SECONDARY outcome

Area under the plasma concentration versus time curve from time 0 to infinite time of CD3+CAR+ Cells in blood after a single infusion of JNJ-68284528 was reported.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=11 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=33 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=2 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinite Time (AUC0-infinity) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528	10937 Days*cells per microliter Standard Deviation 8658	31966 Days*cells per microliter Standard Deviation 58976	7144.5 Days*cells per microliter Standard Deviation 5905

SECONDARY outcome

Timeframe: Days 352 and 1024

Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure. Zero (0) participants in the number analyzed field for arm "Phase 2 (Japan Population)" at Day 1024 signifies that no participants were available for the analysis because no sBCMA samples were collected and analyzed due to change in planned analysis.

Mean concentration of soluble BCMA levels in serum after single infusion of JNJ-68284528 were reported.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=11 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=33 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=8 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: Mean Concentration of Soluble B-cell Maturation Antigen (BCMA) Levels in Serum After Single Infusion of JNJ-68284528 Day 352	2.25 Micrograms per liter (mcg/L) Interval to 7.65 Here, "NA" signifies that lower limit of full range could not be estimated as it was below the quantification limit.	2.01 Micrograms per liter (mcg/L) Interval to 10.4 Here, "NA" signifies that lower limit of full range could not be estimated as it was below the quantification limit.	5.61 Micrograms per liter (mcg/L) Interval to 23.0 Here, "NA" signifies that lower limit of full range could not be estimated as it was below the quantification limit.
Phase 1b and Phase 2: Mean Concentration of Soluble B-cell Maturation Antigen (BCMA) Levels in Serum After Single Infusion of JNJ-68284528 Day 1024	6.70 Micrograms per liter (mcg/L) Interval 0.31 to 14.7	7.05 Micrograms per liter (mcg/L) Interval 3.21 to 11.9	—

SECONDARY outcome

Timeframe: Pre dose (Day 1) up to 2 years

Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure. Due to change in planned analysis, data was not collected and analyzed for "Phase 2 (Japan Population)" in this outcome measure.

Number of participants with depletion of BCMA expressing cells were reported.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=29 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=68 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Number of Participants With Depletion of BCMA Expressing Cells	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Pre-infusion and 2 hours post infusion on Day 1, Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100

Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points for specified categories.

Serum systemic cytokine concentrations (Interleukin \[IL\]-6, IL-10, and Interferon Gamma \[IFN-g\]) were reported.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=29 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=68 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=9 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 6: Day 10	247.99 nanograms per liter Standard Error 464.936	227.01 nanograms per liter Standard Error 405.250	108.05 nanograms per liter Standard Error 171.088
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 10: Day 1 (pre-infusion)	1.19 nanograms per liter Standard Error 1.170	1.68 nanograms per liter Standard Error 2.749	1.07 nanograms per liter Standard Error 0.795
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 10: Day 1 (2 hours post-infusion)	1.11 nanograms per liter Standard Error 0.924	1.94 nanograms per liter Standard Error 3.406	1.07 nanograms per liter Standard Error 0.795
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 10: Day 2	2.85 nanograms per liter	3.86 nanograms per liter Standard Error 6.114	1.90 nanograms per liter Standard Error 1.695
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interferon Gamma: Day1 (pre-infusion)	13.37 nanograms per liter Standard Error 14.658	1.68 nanograms per liter Standard Error 2.749	25.29 nanograms per liter Standard Error 15.168
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interferon Gamma: Day1 (2 hours post-infusion)	21.68 nanograms per liter Standard Error 30.670	35.50 nanograms per liter Standard Error 53.105	25.29 nanograms per liter Standard Error 15.168
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interferon Gamma: Day 7	284.86 nanograms per liter Standard Error 397.735	56.32 nanograms per liter Standard Error 81.383	9043.92 nanograms per liter Standard Error 26714.417
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interferon Gamma: Day 14	44.58 nanograms per liter Standard Error 41.813	6.99 nanograms per liter Standard Error 15.549	59.50 nanograms per liter Standard Error 48.748
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interferon Gamma: Day 100	18.51 nanograms per liter Standard Error 18.052	1.91 nanograms per liter Standard Error 1.920	9.04 nanograms per liter Standard Error 4.958
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 6: Day 1 (Pre-infusion)	3.66 nanograms per liter Standard Error 4.280	3.81 nanograms per liter Standard Error 4.231	1.62 nanograms per liter Standard Error 1.597
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 6: Day 1 (2 hours post-infusion)	3.59 nanograms per liter Standard Error 3.892	4.05 nanograms per liter Standard Error 4.158	1.76 nanograms per liter Standard Error 1.602
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 6: Day 2	4.62 nanograms per liter	6.47 nanograms per liter Standard Error 6.783	2.74 nanograms per liter Standard Error 2.268
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 6: Day 3	7.31 nanograms per liter Standard Error 12.849	25.57 nanograms per liter Standard Error 110.008	3.87 nanograms per liter Standard Error 4.360
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 6: Day 7	25.43 nanograms per liter Standard Error 68.141	200.93 nanograms per liter Standard Error 434.850	128.50 nanograms per liter Standard Error 367.531
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 6: Day 14	42.03 nanograms per liter Standard Error 63.840	110.94 nanograms per liter Standard Error 512.499	20.62 nanograms per liter Standard Error 17.898
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 6: Day 21	227.45 nanograms per liter Standard Error 989.332	69.33 nanograms per liter Standard Error 291.552	14.25 nanograms per liter Standard Error 15.439
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 6: Day 28	67.89 nanograms per liter Standard Error 129.381	110.86 nanograms per liter Standard Error 593.155	18.73 nanograms per liter Standard Error 26.593
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 6: Day 42	56.16 nanograms per liter Standard Error 153.528	141.33 nanograms per liter Standard Error 908.434	12.23 nanograms per liter Standard Error 10.830
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 6: Day 56	12.44 nanograms per liter Standard Error 34.311	113.28 nanograms per liter Standard Error 749.566	8.12 nanograms per liter Standard Error 8.594
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 6: Day 78	56.25 nanograms per liter Standard Error 164.152	137.01 nanograms per liter Standard Error 753.322	3.91 nanograms per liter Standard Error 6.280
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 6: Day 100	2.36 nanograms per liter Standard Error 1.680	239.64 nanograms per liter Standard Error 1491.202	1.45 nanograms per liter Standard Error 1.123
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 10: Day 3	2.65 nanograms per liter Standard Error 2.931	4.54 nanograms per liter Standard Error 8.318	2.10 nanograms per liter Standard Error 1.820
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 10: Day 7	27.95 nanograms per liter Standard Error 30.506	56.32 nanograms per liter Standard Error 81.383	89.21 nanograms per liter Standard Error 163.729
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 10: Day 10	36.44 nanograms per liter Standard Error 56.307	53.78 nanograms per liter Standard Error 156.803	102.71 nanograms per liter Standard Error 184.878
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 10: Day 14	20.50 nanograms per liter Standard Error 90.471	6.99 nanograms per liter Standard Error 15.549	6.20 nanograms per liter Standard Error 6.257
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 10: Day 21	5.14 nanograms per liter Standard Error 5.496	5.36 nanograms per liter Standard Error 14.437	1.06 nanograms per liter Standard Error 0.560
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 10: Day 28	2.30 nanograms per liter Standard Error 1.345	3.45 nanograms per liter Standard Error 6.740	2.19 nanograms per liter Standard Error 1.917
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 10: Day 42	2.36 nanograms per liter Standard Error 3.270	1.94 nanograms per liter Standard Error 2.682	1.52 nanograms per liter Standard Error 0.853
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 10: Day 56	2.17 nanograms per liter Standard Error 2.540	1.54 nanograms per liter Standard Error 0.967	2.38 nanograms per liter Standard Error 2.715
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 10: Day 78	1.84 nanograms per liter Standard Error 2.181	1.64 nanograms per liter Standard Error 1.499	1.08 nanograms per liter Standard Error 0.552
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interleukin 10: Day 100	1.45 nanograms per liter Standard Error 0.881	1.91 nanograms per liter Standard Error 1.920	0.72 nanograms per liter Standard Error 0.272
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interferon Gamma: Day 2	50.87 nanograms per liter	3.86 nanograms per liter Standard Error 6.114	48.01 nanograms per liter Standard Error 30.732
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interferon Gamma: Day 3	57.95 nanograms per liter Standard Error 59.699	4.54 nanograms per liter Standard Error 8.318	44.83 nanograms per liter Standard Error 48.154
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interferon Gamma: Day 10	4095.68 nanograms per liter Standard Error 12586.211	53.78 nanograms per liter Standard Error 156.803	5351.97 nanograms per liter Standard Error 11598.493
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interferon Gamma: Day 21	108.39 nanograms per liter Standard Error 113.492	5.36 nanograms per liter Standard Error 14.437	28.70 nanograms per liter Standard Error 22.852
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interferon Gamma: Day 28	57.44 nanograms per liter Standard Error 82.982	3.45 nanograms per liter Standard Error 6.740	44.36 nanograms per liter Standard Error 45.668
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interferon Gamma: Day 42	32.69 nanograms per liter Standard Error 39.456	1.94 nanograms per liter Standard Error 2.682	22.76 nanograms per liter Standard Error 22.233
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interferon Gamma: Day 56	50.58 nanograms per liter Standard Error 143.096	1.54 nanograms per liter Standard Error 0.967	19.88 nanograms per liter Standard Error 32.794
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations Interferon Gamma: Day 78	26.19 nanograms per liter Standard Error 34.120	1.64 nanograms per liter Standard Error 1.499	7.71 nanograms per liter Standard Error 4.433

SECONDARY outcome

Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.

Cmax of CAR-T cells (CD3+CAR+ cells in blood) after a single infusion of JNJ-68284528 was reported.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=29 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=68 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=9 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of CAR-T Cells (CD3+CAR+ Cells in Blood) After a Single Infusion of JNJ-68284528	483 Cells per microliter Standard Deviation 464	1472 Cells per microliter Standard Deviation 2085	1614 Cells per microliter Standard Deviation 3718

SECONDARY outcome

Population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.

Maximum T cell expansion was defined as maximum observed plasma concentration (Cmax) after a single Infusion of JNJ-68284528.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=29 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=68 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=9 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: Maximum T Cell Expansion After a Single Infusion of JNJ-68284528	483 Cells per microliter Standard Deviation 464	1472 Cells per microliter Standard Deviation 2085	1614 Cells per microliter Standard Deviation 3718

SECONDARY outcome

Timeframe: Pre dose (Day 1) up to 2 years

Population: All treated analysis set included all participants who received JNJ-68284528 infusion.

Percentage of participants with positive antibodies to JNJ-68284528 were reported.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=29 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=68 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=9 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: Percentage of Participants With Positive Antibodies to JNJ-68284528	48.3 Percentage of participants	35.3 Percentage of participants	44.4 Percentage of participants

SECONDARY outcome

Timeframe: Pre dose (Day 1) up to 45.2 months

Population: mITT analysis Set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

VGPR or better response rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response \[sCR\]) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or \>= 90% reduction in serum M-protein plus urine M-protein level less than (\<) 100 mg/24 hour; CR: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<5% PCs in bone marrow; sCR: CR in addition to having a normal free light chain (FLC) ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=29 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=68 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=8 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: Very Good Partial Response (VGPR) or Better Response Rate	96.6 Percentage of participants Interval 82.2 to 99.9	94.1 Percentage of participants Interval 85.6 to 98.4	100.0 Percentage of participants Interval 63.1 to 100.0

SECONDARY outcome

Timeframe: Pre dose (Day 1) up to 45.2 months

MRD negativity rate was defined as percentage of participants who had negative MRD by bone marrow aspirate at any timepoint after initial dose of JNJ-68284528 and before disease progression or starting subsequent therapy or retreatment with JNJ-68284528. MRD negativity rate was assessed by next-generation sequencing at a threshold of \<10\^5.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=18 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=39 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=8 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: Minimal Residual Disease (MRD) Negative Rate	100.0 Percentage of participants Interval 81.5 to 100.0	89.7 Percentage of participants Interval 75.8 to 97.1	75.0 Percentage of participants Interval 34.9 to 96.8

SECONDARY outcome

Timeframe: Pre dose (Day 1) up to 45.2 months

Population: mITT analysis Set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.

Clinical benefit rate was defined as the percentage of participants with best response of minimal response (MR) or better (including sCR, CR, VGPR, PR, and MR). MR was defined as \>=25% but less than or equal to (\<=) 49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. In addition to the above criteria, if present at baseline, \>=50% reduction in the size of soft tissue plasmacytomas was also required.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=29 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=68 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=9 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: Clinical Benefit Rate (CBR)	100.0 Percentage of participants Interval 88.1 to 100.0	97.1 Percentage of participants Interval 89.8 to 99.6	100.0 Percentage of participants Interval 63.1 to 100.0

SECONDARY outcome

Timeframe: Pre dose (Day 1) up to first documented PD or death (up to 45.2 months)

Population: Analysis population included responders (who achieved PR or better response) in mITT analysis set. mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.

DOR was defined as the time (in months) from the date of initial documented response (PR or better response) to the date of first documented evidence of progressive disease (PD) or death. PD is defined as an increase of 25% from the lowest response value in one of the following: serum and urine M-component (absolute increase must be \>=0.5 gram per deciliter \[g/dL\] and \>=200 mg/24 hours respectively); only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dL); definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to PC proliferative disorder, appearance of a new lesion(s), \>=50% increase in circulating plasma cells if this was the only measure of disease.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=29 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=66 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=8 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: Duration of Response (DOR)	NA Months Interval 15.9 to Here, NA signifies that median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.	NA Months Interval 23.1 to Here, NA signifies that median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.	NA Months Interval 10.3 to Here, NA signifies that median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Pre dose (Day 1) up to 45.2 months

Population: Analysis population included responders in mITT analysis set. mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level.

Time to first response was defined as the time between date of the initial infusion of JNJ-68284528 and the first efficacy evaluation that the participant met all criteria for PR or better. IMWG criteria for PR: \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or \<200 mg per 24 hours, If the serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, \>=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \>=30%. In addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=29 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=66 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=8 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: Time to First Response	0.95 Months Interval 0.9 to 2.8	0.95 Months Interval 0.9 to 10.7	0.92 Months Interval 0.9 to 1.8

SECONDARY outcome

Timeframe: Pre dose (Day 1) up to 45.2 months

Progression-free survival was defined as the time from the date of the initial infusion of JNJ-68284528 to the date of first documented disease progression.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=29 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=68 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=8 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: Progression-free Survival (PFS)	NA Months Interval 16.79 to Here, NA signifies that median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.	NA Months Interval 24.08 to Here, NA signifies that median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.	NA Months Interval 11.17 to Here, NA signifies that median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Pre dose (Day 1) up to 45.2 months

Overall survival was defined as the time from the date of the initial infusion of JNJ-68284528 to the date of the participant's death.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=29 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=68 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) n=8 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 1b and Phase 2: Overall Survival	NA Months Interval 27.24 to Here, NA signifies that median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.	NA Months Interval 32.2 to Here, NA signifies that median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.	27.04 Months Interval 18.4 to Here, NA signifies that upper limit of 95% CI could not be estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380

EQ-5D-5L was a 5-item questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 response levels: 1 =no problems, 2 =slight problems, 3 =moderate problems, 4 =severe problems and 5 =extreme problems. The scores for the 5 dimensions were used to compute a single utility score ranging from 0 to 1 representing the general health status of the individual. Higher score indicated better health status. EQ-5D VAS was used to record participant's rating for his/her "health today" and ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=54 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 78	0 Score on a scale Interval 0.0 to 0.1	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 268	0.1 Score on a scale Interval 0.0 to 0.1	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 324	0 Score on a scale Interval 0.0 to 0.1	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 7	-0.1 Score on a scale Interval -0.1 to 0.0	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 28	0 Score on a scale Interval -0.1 to 0.0	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 56	0 Score on a scale Interval -0.1 to 0.1	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 100	0 Score on a scale Interval 0.0 to 0.1	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 128	0 Score on a scale Interval 0.0 to 0.1	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 156	0 Score on a scale Interval 0.0 to 0.1	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 184	0 Score on a scale Interval 0.0 to 0.1	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 212	0.1 Score on a scale Interval 0.0 to 0.1	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 240	0.1 Score on a scale Interval 0.0 to 0.1	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 296	0.1 Score on a scale Interval 0.0 to 0.1	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 352	0.1 Score on a scale Interval 0.0 to 0.2	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 380	-0.1 Score on a scale Interval -0.3 to 0.2	—	—

SECONDARY outcome

Timeframe: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=8 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 100	-0.04 Score on a scale Standard Deviation 0.075	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 268	0.07 Score on a scale Standard Deviation 0.096	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 7	-0.05 Score on a scale Standard Deviation 0.149	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 28	-0.06 Score on a scale Standard Deviation 0.185	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 56	-0.03 Score on a scale Standard Deviation 0.057	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 78	0.01 Score on a scale Standard Deviation 0.098	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 128	0.00 Score on a scale Standard Deviation 0.063	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 156	-0.02 Score on a scale Standard Deviation 0.053	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 184	-0.01 Score on a scale Standard Deviation 0.079	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 212	0.04 Score on a scale Standard Deviation 0.109	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 240	0.05 Score on a scale Standard Deviation 0.079	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 296	0.04 Score on a scale Standard Deviation 0.061	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 324	0.14 Score on a scale Standard Deviation NA Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.	—	—

SECONDARY outcome

Timeframe: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380

EQ-5D-5L was a 5-item questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 response levels: 1 =no problems, 2 =slight problems, 3 =moderate problems, 4 =severe problems and 5 =extreme problems. The scores for the 5 dimensions were used to compute a single utility score ranging from 0 to 1 representing the general health status of the individual. Higher score indicated better health status. EQ-5D VAS was used to record participant's rating for his/her "health today" and ranging from 0 to 100, where 0 =worst imaginable health state and 100 = best imaginable health state.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=53 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 56	2.2 Score on a scale Interval -2.3 to 6.7	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 184	6.1 Score on a scale Interval 1.2 to 10.9	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 7	-6.7 Score on a scale Interval -11.1 to -2.3	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 28	0.6 Score on a scale Interval -3.8 to 5.0	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 78	5.3 Score on a scale Interval 0.7 to 9.9	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 100	1.9 Score on a scale Interval -2.6 to 6.4	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 128	6.4 Score on a scale Interval 1.6 to 11.3	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 156	4.8 Score on a scale Interval -0.2 to 9.8	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 212	9.6 Score on a scale Interval 4.5 to 14.7	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 240	11 Score on a scale Interval 5.9 to 16.2	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 268	7.2 Score on a scale Interval 2.3 to 12.2	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 296	10 Score on a scale Interval 4.8 to 15.2	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 324	11.9 Score on a scale Interval 4.9 to 18.9	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 352	10.2 Score on a scale Interval 0.8 to 19.7	—	—
Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Change at Day 380	-2 Score on a scale Interval -19.1 to 15.1	—	—

SECONDARY outcome

Timeframe: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=8 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 28	-0.75 Score on a scale Standard Deviation 8.795	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 56	-4.50 Score on a scale Standard Deviation 6.803	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 156	0.00 Score on a scale Standard Deviation 8.452	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 184	-0.25 Score on a scale Standard Deviation 7.005	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 212	2.50 Score on a scale Standard Deviation 9.586	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 240	0.00 Score on a scale Standard Deviation 8.660	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 7	-13.75 Score on a scale Standard Deviation 17.269	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 78	-3.00 Score on a scale Standard Deviation 9.914	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 100	-1.88 Score on a scale Standard Deviation 7.530	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 128	0.00 Score on a scale Standard Deviation 11.019	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 268	-2.50 Score on a scale Standard Deviation 10.607	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 296	-12.50 Score on a scale Standard Deviation 24.749	—	—
Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Change at Day 324	-10.00 Score on a scale Standard Deviation NA Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.	—	—

SECONDARY outcome

Timeframe: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380

EORTC QLQ-C30 was a 30 items self-reporting questionnaire, with 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status scale (GHS), 3 symptom scales (fatigue, nausea and vomiting, and pain) and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Questionnaire includes 28 items with 4-point Likert type responses from "1-not at all" to "4-very much" to assess functioning and symptoms;2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall health related QoL. Scores are transformed to 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values shows deterioration in quality of life or functioning and reduction in symptom and positive values indicate improvement and worsening of symptoms.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=54 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Physical functional scales: Change at Day 7	-14.4 Score on a scale Interval -19.7 to -9.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Physical functional scales: Change at Day 28	-7.2 Score on a scale Interval -12.4 to -1.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Physical functional scales: Change at Day 78	-2.3 Score on a scale Interval -7.7 to 3.1	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Physical functional scales: Change at Day 128	0 Score on a scale Interval -5.6 to 5.7	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Physical functional scales: Change at Day 184	-0.6 Score on a scale Interval -6.3 to 5.1	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Physical functional scales: Change at Day 212	2.2 Score on a scale Interval -3.9 to 8.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Physical functional scales: Change at Day 240	1.5 Score on a scale Interval -4.5 to 7.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Physical functional scales: Change at Day 268	2.4 Score on a scale Interval -3.4 to 8.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Physical functional scales: Change at Day 296	3.1 Score on a scale Interval -2.9 to 9.1	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Physical functional scales: Change at Day 380	-5.5 Score on a scale Interval -24.2 to 13.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Role functional scales: Change at Day 7	-24.2 Score on a scale Interval -32.1 to -16.3	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Role functional scales: Change at Day 128	0.3 Score on a scale Interval -8.3 to 9.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Role functional scales: Change at Day 212	0.3 Score on a scale Interval -8.9 to 9.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Role functional scales: Change at Day 324	7.3 Score on a scale Interval -5.0 to 19.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Emotional functional scales: Change at Day 7	3.1 Score on a scale Interval -1.1 to 7.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Emotional functional scales: Change at Day 56	5.6 Score on a scale Interval 1.3 to 9.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Emotional functional scales: Change at Day 240	7.2 Score on a scale Interval 2.4 to 12.1	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Emotional functional scales: Change at Day 352	8.8 Score on a scale Interval 0.1 to 17.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Emotional functional scales: Change at Day 380	16 Score on a scale Interval 0.4 to 31.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Cognitive functional scales: Change at Day 156	4.2 Score on a scale Interval -0.8 to 9.3	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Cognitive functional scales: Change at Day 352	4.2 Score on a scale Interval -5.8 to 14.1	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Social functional scales: Change at Day 28	-13.8 Score on a scale Interval -20.9 to -6.7	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Social functional scales: Change at Day 78	-3.8 Score on a scale Interval -11.2 to 3.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Social functional scales: Change at Day 100	-3.5 Score on a scale Interval -10.8 to 3.8	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Social functional scales: Change at Day 156	-1.5 Score on a scale Interval -9.5 to 6.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Social functional scales: Change at Day 380	-0.5 Score on a scale Interval -27.7 to 26.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Global health status scale: Change at Day 240	9.6 Score on a scale Interval 3.3 to 16.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Global health status scale: Change at Day 296	10.4 Score on a scale Interval 4.2 to 16.7	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Pain symptom scales: Change at Day 7	-1.9 Score on a scale Interval -8.5 to 4.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Pain symptom scales: Change at Day 56	-6.3 Score on a scale Interval -12.9 to 0.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Pain symptom scales: Change at Day 78	-9.4 Score on a scale Interval -16.3 to -2.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Pain symptom scales: Change at Day 100	-10.5 Score on a scale Interval -17.3 to -3.8	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Pain symptom scales: Change at Day 128	-11.8 Score on a scale Interval -19.1 to -4.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Pain symptom scales: Change at Day 156	-13.1 Score on a scale Interval -20.6 to -5.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Pain symptom scales: Change at Day 184	-10 Score on a scale Interval -17.3 to -2.7	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Pain symptom scales: Change at Day 212	-11.7 Score on a scale Interval -19.5 to -3.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Pain symptom scales: Change at Day 296	-15.6 Score on a scale Interval -23.5 to -7.8	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Pain symptom scales: Change at Day 380	-0.7 Score on a scale Interval -28.2 to 26.7	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Fatigue symptom scales: Change at Day 28	10.3 Score on a scale Interval 4.6 to 16.1	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Fatigue symptom scales: Change at Day 56	4 Score on a scale Interval -1.7 to 9.7	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Fatigue symptom scales: Change at Day 100	0 Score on a scale Interval -5.9 to 5.8	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Fatigue symptom scales: Change at Day 184	-8.1 Score on a scale Interval -14.3 to -1.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Fatigue symptom scales: Change at Day 296	-14.2 Score on a scale Interval -20.8 to -7.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Nausea/vomiting symptom scales: Change at Day 56	2.2 Score on a scale Interval -1.5 to 5.8	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Nausea/vomiting symptom scales: Change at Day 100	-0.2 Score on a scale Interval -4.0 to 3.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Nausea/vomiting symptom scales: Change at Day 128	-2.6 Score on a scale Interval -6.6 to 1.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Nausea/vomiting symptom scales: Change at Day 184	-0.2 Score on a scale Interval -4.2 to 3.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Nausea/vomiting symptom scales: Change at Day 352	-4.4 Score on a scale Interval -13.4 to 4.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Dyspnea: Change at Day 7	2.6 Score on a scale Interval -2.7 to 8.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Dyspnea: Change at Day 28	4.6 Score on a scale Interval -0.8 to 10.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Dyspnea: Change at Day 56	1.3 Score on a scale Interval -4.1 to 6.8	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Dyspnea: Change at Day 78	-1.9 Score on a scale Interval -7.6 to 3.8	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Dyspnea: Change at Day 128	-1.5 Score on a scale Interval -7.6 to 4.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Dyspnea: Change at Day 184	-2.9 Score on a scale Interval -8.9 to 3.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Dyspnea: Change at Day 352	-6.5 Score on a scale Interval -19.4 to 6.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Insomnia: Change at Day 78	-2.6 Score on a scale Interval -9.5 to 4.3	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Insomnia: Change at Day 128	-7.1 Score on a scale Interval -14.4 to 0.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Insomnia: Change at Day 156	-7.1 Score on a scale Interval -14.7 to 0.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Insomnia: Change at Day 240	-6.3 Score on a scale Interval -14.2 to 1.7	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Cognitive functional scales: Change at Day 7	-0.4 Score on a scale Interval -4.8 to 4.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Cognitive functional scales: Change at Day 28	1.6 Score on a scale Interval -2.8 to 6.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Cognitive functional scales: Change at Day 56	1.2 Score on a scale Interval -3.3 to 5.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Cognitive functional scales: Change at Day 78	4.4 Score on a scale Interval -0.2 to 9.1	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Cognitive functional scales: Change at Day 100	2.3 Score on a scale Interval -2.3 to 6.8	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Cognitive functional scales: Change at Day 128	5 Score on a scale Interval 0.1 to 9.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Cognitive functional scales: Change at Day 184	4.1 Score on a scale Interval -0.7 to 9.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Cognitive functional scales: Change at Day 212	7.4 Score on a scale Interval 2.2 to 12.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Cognitive functional scales: Change at Day 240	8.6 Score on a scale Interval 3.4 to 13.8	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Cognitive functional scales: Change at Day 268	5.6 Score on a scale Interval 0.7 to 10.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Cognitive functional scales: Change at Day 296	5.2 Score on a scale Interval 0.0 to 10.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Cognitive functional scales: Change at Day 324	9.3 Score on a scale Interval 2.0 to 16.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Cognitive functional scales: Change at Day 380	22 Score on a scale Interval 3.7 to 40.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Social functional scales: Change at Day 7	-28.5 Score on a scale Interval -35.6 to -21.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Social functional scales: Change at Day 56	-9.4 Score on a scale Interval -16.5 to -2.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Social functional scales: Change at Day 128	-1.2 Score on a scale Interval -9.0 to 6.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Social functional scales: Change at Day 184	0.4 Score on a scale Interval -7.4 to 8.1	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Social functional scales: Change at Day 212	-1.3 Score on a scale Interval -9.4 to 6.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Social functional scales: Change at Day 240	1.1 Score on a scale Interval -7.1 to 9.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Social functional scales: Change at Day 268	-0.5 Score on a scale Interval -8.3 to 7.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Social functional scales: Change at Day 296	2.2 Score on a scale Interval -5.9 to 10.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Social functional scales: Change at Day 324	0.5 Score on a scale Interval -10.7 to 11.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Social functional scales: Change at Day 352	-0.1 Score on a scale Interval -15.0 to 14.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Global health status scale: Change at Day 7	-9.7 Score on a scale Interval -15.1 to -4.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Global health status scale: Change at Day 28	-0.6 Score on a scale Interval -5.9 to 4.7	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Global health status scale: Change at Day 56	1.5 Score on a scale Interval -3.9 to 6.8	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Global health status scale: Change at Day 78	4.7 Score on a scale Interval -0.9 to 10.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Global health status scale: Change at Day 100	2.5 Score on a scale Interval -3.0 to 8.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Global health status scale: Change at Day 128	8.3 Score on a scale Interval 2.3 to 14.3	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Global health status scale: Change at Day 156	8.4 Score on a scale Interval 2.3 to 14.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Global health status scale: Change at Day 184	8.9 Score on a scale Interval 3.1 to 14.8	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Global health status scale: Change at Day 212	7.7 Score on a scale Interval 1.5 to 14.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Global health status scale: Change at Day 268	7.8 Score on a scale Interval 1.8 to 13.8	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Global health status scale: Change at Day 324	11.5 Score on a scale Interval 2.6 to 20.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Global health status scale: Change at Day 352	19.9 Score on a scale Interval 7.8 to 32.1	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Global health status scale: Change at Day 380	4.4 Score on a scale Interval -17.9 to 26.8	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Pain symptom scales: Change at Day 28	-9.9 Score on a scale Interval -16.5 to -3.3	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Physical functional scales: Change at Day 56	-5.2 Score on a scale Interval -10.5 to 0.1	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Physical functional scales: Change at Day 100	-4.8 Score on a scale Interval -10.2 to 0.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Physical functional scales: Change at Day 156	-3.9 Score on a scale Interval -9.7 to 2.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Physical functional scales: Change at Day 324	6.6 Score on a scale Interval -1.3 to 14.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Physical functional scales: Change at Day 352	6.4 Score on a scale Interval -4.1 to 16.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Role functional scales: Change at Day 28	-12.3 Score on a scale Interval -20.3 to -4.3	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Role functional scales: Change at Day 56	-8.5 Score on a scale Interval -16.5 to -0.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Role functional scales: Change at Day 78	-3.5 Score on a scale Interval -11.8 to 4.8	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Role functional scales: Change at Day 100	-3 Score on a scale Interval -11.2 to 5.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Role functional scales: Change at Day 156	-3.7 Score on a scale Interval -12.7 to 5.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Role functional scales: Change at Day 184	1.1 Score on a scale Interval -7.6 to 9.7	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Role functional scales: Change at Day 240	1.3 Score on a scale Interval -7.9 to 10.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Role functional scales: Change at Day 268	5.5 Score on a scale Interval -3.4 to 14.3	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Role functional scales: Change at Day 296	4.2 Score on a scale Interval -5.0 to 13.3	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Role functional scales: Change at Day 352	8.3 Score on a scale Interval -8.1 to 24.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Role functional scales: Change at Day 380	-3.5 Score on a scale Interval -33.0 to 25.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Emotional functional scales: Change at Day 28	6.1 Score on a scale Interval 1.9 to 10.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Emotional functional scales: Change at Day 78	5.7 Score on a scale Interval 1.3 to 10.1	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Emotional functional scales: Change at Day 100	4.8 Score on a scale Interval 0.5 to 9.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Emotional functional scales: Change at Day 128	6.3 Score on a scale Interval 1.7 to 10.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Emotional functional scales: Change at Day 156	1.7 Score on a scale Interval -3.0 to 6.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Emotional functional scales: Change at Day 184	5.7 Score on a scale Interval 1.1 to 10.3	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Emotional functional scales: Change at Day 212	6.3 Score on a scale Interval 1.4 to 11.1	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Emotional functional scales: Change at Day 268	5.9 Score on a scale Interval 1.3 to 10.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Emotional functional scales: Change at Day 296	8.4 Score on a scale Interval 3.5 to 13.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Emotional functional scales: Change at Day 324	12 Score on a scale Interval 5.5 to 18.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Pain symptom scales: Change at Day 240	-16.2 Score on a scale Interval -24.1 to -8.3	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Pain symptom scales: Change at Day 268	-16.7 Score on a scale Interval -24.2 to -9.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Pain symptom scales: Change at Day 324	-14.9 Score on a scale Interval -25.9 to -3.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Pain symptom scales: Change at Day 352	-17.6 Score on a scale Interval -32.6 to -2.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Fatigue symptom scales: Change at Day 7	14.3 Score on a scale Interval 8.7 to 20.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Fatigue symptom scales: Change at Day 78	-5.9 Score on a scale Interval -11.8 to 0.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Fatigue symptom scales: Change at Day 128	-7.7 Score on a scale Interval -13.9 to -1.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Fatigue symptom scales: Change at Day 156	-5.1 Score on a scale Interval -11.5 to 1.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Fatigue symptom scales: Change at Day 212	-11.5 Score on a scale Interval -18.1 to -4.8	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Fatigue symptom scales: Change at Day 240	-12.6 Score on a scale Interval -19.2 to -5.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Fatigue symptom scales: Change at Day 268	-13.4 Score on a scale Interval -19.8 to -7.1	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Fatigue symptom scales: Change at Day 324	-14.6 Score on a scale Interval -23.6 to -5.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Fatigue symptom scales: Change at Day 352	-15.7 Score on a scale Interval -27.7 to -3.7	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Fatigue symptom scales: Change at Day 380	-5.6 Score on a scale Interval -27.3 to 16.1	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Nausea/vomiting symptom scales: Change at Day 7	13.3 Score on a scale Interval 9.8 to 16.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Nausea/vomiting symptom scales: Change at Day 28	1.7 Score on a scale Interval -1.9 to 5.3	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Nausea/vomiting symptom scales: Change at Day 78	-0.2 Score on a scale Interval -4.0 to 3.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Nausea/vomiting symptom scales: Change at Day 156	-2.6 Score on a scale Interval -6.9 to 1.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Nausea/vomiting symptom scales: Change at Day 212	-1 Score on a scale Interval -5.5 to 3.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Nausea/vomiting symptom scales: Change at Day 240	-3.4 Score on a scale Interval -7.9 to 1.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Nausea/vomiting symptom scales: Change at Day 268	-2.5 Score on a scale Interval -6.7 to 1.7	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Nausea/vomiting symptom scales: Change at Day 296	-3.5 Score on a scale Interval -7.9 to 1.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Nausea/vomiting symptom scales: Change at Day 324	-2.9 Score on a scale Interval -9.4 to 3.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Nausea/vomiting symptom scales: Change at Day 380	4.5 Score on a scale Interval -12.3 to 21.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Dyspnea: Change at Day 100	-3 Score on a scale Interval -8.7 to 2.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Dyspnea: Change at Day 156	-1.3 Score on a scale Interval -7.6 to 5.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Dyspnea: Change at Day 212	-7 Score on a scale Interval -13.6 to -0.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Dyspnea: Change at Day 240	-4.1 Score on a scale Interval -10.7 to 2.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Dyspnea: Change at Day 268	-8.7 Score on a scale Interval -15.0 to -2.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Dyspnea: Change at Day 296	-10.9 Score on a scale Interval -17.5 to -4.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Dyspnea: Change at Day 324	-7.6 Score on a scale Interval -17.0 to 1.8	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Dyspnea: Change at Day 380	-22.5 Score on a scale Interval -46.3 to 1.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Insomnia: Change at Day 7	9.4 Score on a scale Interval 2.9 to 15.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Insomnia: Change at Day 28	-4.6 Score on a scale Interval -11.2 to 2.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Insomnia: Change at Day 56	-1.4 Score on a scale Interval -8.0 to 5.3	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Insomnia: Change at Day 100	-3.1 Score on a scale Interval -9.9 to 3.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Insomnia: Change at Day 184	-2.3 Score on a scale Interval -9.6 to 5.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Insomnia: Change at Day 212	-4.4 Score on a scale Interval -12.4 to 3.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Insomnia: Change at Day 268	-6.7 Score on a scale Interval -14.3 to 0.8	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Insomnia: Change at Day 296	-4.9 Score on a scale Interval -12.8 to 3.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Insomnia: Change at Day 324	-1.6 Score on a scale Interval -12.9 to 9.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Insomnia: Change at Day 352	1 Score on a scale Interval -14.4 to 16.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Insomnia: Change at Day 380	-18.3 Score on a scale Interval -46.7 to 10.1	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Appetite loss: Change at Day 7	22.2 Score on a scale Interval 16.0 to 28.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Appetite loss: Change at Day 28	8.4 Score on a scale Interval 2.1 to 14.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Appetite loss: Change at Day 56	2.5 Score on a scale Interval -3.8 to 8.8	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Appetite loss: Change at Day 78	-0.7 Score on a scale Interval -7.3 to 5.8	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Appetite loss: Change at Day 100	3 Score on a scale Interval -3.5 to 9.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Appetite loss: Change at Day 128	-4.3 Score on a scale Interval -11.3 to 2.7	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Appetite loss: Change at Day 156	-5 Score on a scale Interval -12.3 to 2.3	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Appetite loss: Change at Day 184	-4.7 Score on a scale Interval -11.7 to 2.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Appetite loss: Change at Day 212	-7.9 Score on a scale Interval -15.5 to -0.3	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Appetite loss: Change at Day 240	-10.5 Score on a scale Interval -18.1 to -2.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Appetite loss: Change at Day 268	-12.4 Score on a scale Interval -19.6 to -5.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Appetite loss: Change at Day 296	-11 Score on a scale Interval -18.5 to -3.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Appetite loss: Change at Day 324	-9.5 Score on a scale Interval -20.4 to 1.3	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Appetite loss: Change at Day 352	-9.8 Score on a scale Interval -24.8 to 5.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Appetite loss: Change at Day 380	-6.1 Score on a scale Interval -33.7 to 21.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Constipation: Change at Day 7	12.7 Score on a scale Interval 8.4 to 17.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Constipation: Change at Day 28	-0.1 Score on a scale Interval -4.5 to 4.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Constipation: Change at Day 56	-2 Score on a scale Interval -6.4 to 2.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Constipation: Change at Day 78	-6.3 Score on a scale Interval -10.9 to -1.7	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Constipation: Change at Day 100	-7 Score on a scale Interval -11.5 to -2.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Constipation: Change at Day 128	-4.5 Score on a scale Interval -9.4 to 0.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Constipation: Change at Day 156	-6.3 Score on a scale Interval -11.5 to -1.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Constipation: Change at Day 184	-8.1 Score on a scale Interval -13.0 to -3.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Constipation: Change at Day 212	-4.4 Score on a scale Interval -9.8 to 1.1	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Constipation: Change at Day 240	-10.1 Score on a scale Interval -15.5 to -4.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Constipation: Change at Day 268	-6.6 Score on a scale Interval -11.7 to -1.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Constipation: Change at Day 296	-7.1 Score on a scale Interval -12.4 to -1.7	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Constipation: Change at Day 324	-9.3 Score on a scale Interval -17.2 to -1.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Constipation: Change at Day 352	-12.3 Score on a scale Interval -23.3 to -1.3	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Constipation: Change at Day 380	-16.5 Score on a scale Interval -36.0 to 36.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Diarrhea: Change at Day 7	1.7 Score on a scale Interval -3.6 to 6.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Diarrhea: Change at Day 28	-3.1 Score on a scale Interval -8.4 to 2.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Diarrhea: Change at Day 56	1.2 Score on a scale Interval -4.1 to 6.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Diarrhea: Change at Day 78	5 Score on a scale Interval -0.5 to 10.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Diarrhea: Change at Day 100	0.1 Score on a scale Interval -5.3 to 5.5	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Diarrhea: Change at Day 128	-1.6 Score on a scale Interval -7.5 to 4.3	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Diarrhea: Change at Day 156	1.1 Score on a scale Interval -5.0 to 7.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Diarrhea: Change at Day 184	-4.5 Score on a scale Interval -10.3 to 1.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Diarrhea: Change at Day 212	-6.8 Score on a scale Interval -13.1 to -0.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Diarrhea: Change at Day 240	-2.6 Score on a scale Interval -9.0 to 3.7	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Diarrhea: Change at Day 268	-5.4 Score on a scale Interval -11.3 to 0.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Diarrhea: Change at Day 296	-8.2 Score on a scale Interval -14.5 to -2.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Diarrhea: Change at Day 324	-12.2 Score on a scale Interval -21.3 to -3.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Diarrhea: Change at Day 352	-11.9 Score on a scale Interval -24.5 to 0.7	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Diarrhea: Change at Day 380	-26.2 Score on a scale Interval -49.5 to -2.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Financial difficulties: Change at Day 7	3.8 Score on a scale Interval -2.5 to 10.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Financial difficulties: Change at Day 28	-2.7 Score on a scale Interval -8.9 to 3.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Financial difficulties: Change at Day 56	-1.4 Score on a scale Interval -7.7 to 4.9	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Financial difficulties: Change at Day 78	-4.5 Score on a scale Interval -10.9 to 2.0	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Financial difficulties: Change at Day 100	-4.3 Score on a scale Interval -10.7 to 2.1	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Financial difficulties: Change at Day 128	-6.4 Score on a scale Interval -13.3 to 0.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Financial difficulties: Change at Day 156	-4.7 Score on a scale Interval -11.7 to 2.3	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Financial difficulties: Change at Day 184	-5.2 Score on a scale Interval -11.9 to 1.6	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Financial difficulties: Change at Day 212	-2.7 Score on a scale Interval -9.8 to 4.4	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Financial difficulties: Change at Day 240	-4.1 Score on a scale Interval -11.3 to 3.1	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Financial difficulties: Change at Day 268	-9.1 Score on a scale Interval -15.9 to -2.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Financial difficulties: Change at Day 296	-8.3 Score on a scale Interval -15.5 to -1.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Financial difficulties: Change at Day 324	-12 Score on a scale Interval -21.7 to -2.3	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Financial difficulties: Change at Day 352	-12.8 Score on a scale Interval -25.8 to 0.2	—	—
Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Financial difficulties: Change at Day 380	-21.2 Score on a scale Interval -44.6 to 2.3	—	—

SECONDARY outcome

Timeframe: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=8 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Fatigue symptom scales: Change at Day 156	2.78 Score on a scale Standard Deviation 7.857	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Dyspnea: Change at Day 156	-12.50 Score on a scale Standard Deviation 24.801	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Financial difficulties: Change at Day 212	-11.11 Score on a scale Standard Deviation 27.217	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Emotional functional scales: Change at Day 78	4.17 Score on a scale Standard Deviation 9.960	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Physical functional scales: Change at Day 7	-2.50 Score on a scale Standard Deviation 12.312	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Physical functional scales: Change at Day 28	-4.17 Score on a scale Standard Deviation 10.040	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Physical functional scales: Change at Day 56	-1.67 Score on a scale Standard Deviation 6.901	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Physical functional scales: Change at Day 78	0.00 Score on a scale Standard Deviation 3.563	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Physical functional scales: Change at Day 100	-1.67 Score on a scale Standard Deviation 5.909	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Physical functional scales: Change at Day 128	-0.83 Score on a scale Standard Deviation 8.309	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Physical functional scales: Change at Day 156	0.83 Score on a scale Standard Deviation 6.607	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Physical functional scales: Change at Day 184	4.17 Score on a scale Standard Deviation 4.960	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Physical functional scales: Change at Day 212	4.44 Score on a scale Standard Deviation 5.443	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Physical functional scales: Change at Day 240	4.44 Score on a scale Standard Deviation 7.698	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Physical functional scales: Change at Day 268	-3.33 Score on a scale Standard Deviation 4.714	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Physical functional scales: Change at Day 296	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Physical functional scales: Change at Day 324	0.00 Score on a scale	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Role functional scales: Change at Day 7	-10.42 Score on a scale Standard Deviation 15.269	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Role functional scales: Change at Day 28	-8.33 Score on a scale Standard Deviation 17.817	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Role functional scales: Change at Day 56	-12.50 Score on a scale Standard Deviation 17.252	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Role functional scales: Change at Day 78	-6.25 Score on a scale Standard Deviation 26.633	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Role functional scales: Change at Day 100	-6.25 Score on a scale Standard Deviation 15.269	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Role functional scales: Change at Day 128	-16.67 Score on a scale Standard Deviation 26.726	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Role functional scales: Change at Day 156	-10.42 Score on a scale Standard Deviation 26.633	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Role functional scales: Change at Day 184	-10.42 Score on a scale Standard Deviation 29.463	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Role functional scales: Change at Day 212	-8.33 Score on a scale Standard Deviation 20.412	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Role functional scales: Change at Day 240	-11.11 Score on a scale Standard Deviation 19.245	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Role functional scales: Change at Day 268	-8.33 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Role functional scales: Change at Day 296	-16.67 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Role functional scales: Change at Day 324	-16.67 Score on a scale Standard Deviation NA Standard deviation (SD) could not be calculated as only 1 participant was available.	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Emotional functional scales: Change at Day 7	2.08 Score on a scale Standard Deviation 9.708	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Emotional functional scales: Change at Day 28	1.04 Score on a scale Standard Deviation 8.259	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Emotional functional scales: Change at Day 56	6.25 Score on a scale Standard Deviation 8.626	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Emotional functional scales: Change at Day 100	5.21 Score on a scale Standard Deviation 8.839	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Emotional functional scales: Change at Day 128	3.13 Score on a scale Standard Deviation 11.732	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Emotional functional scales: Change at Day 156	5.21 Score on a scale Standard Deviation 9.898	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Emotional functional scales: Change at Day 184	9.38 Score on a scale Standard Deviation 6.954	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Emotional functional scales: Change at Day 212	2.78 Score on a scale Standard Deviation 6.804	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Emotional functional scales: Change at Day 240	11.11 Score on a scale Standard Deviation 9.623	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Emotional functional scales: Change at Day 268	8.33 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Emotional functional scales: Change at Day 296	-4.17 Score on a scale Standard Deviation 5.893	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Emotional functional scales: Change at Day 324	16.67 Score on a scale Standard Deviation NA Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Cognitive functional scales: Change at Day 7	-4.17 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Cognitive functional scales: Change at Day 28	2.08 Score on a scale Standard Deviation 5.893	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Cognitive functional scales: Change at Day 56	-4.17 Score on a scale Standard Deviation 14.773	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Cognitive functional scales: Change at Day 78	0.00 Score on a scale Standard Deviation 12.599	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Cognitive functional scales: Change at Day 100	-2.08 Score on a scale Standard Deviation 10.681	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Cognitive functional scales: Change at Day 128	-4.17 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Cognitive functional scales: Change at Day 156	0.00 Score on a scale Standard Deviation 15.430	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Cognitive functional scales: Change at Day 184	2.08 Score on a scale Standard Deviation 13.909	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Cognitive functional scales: Change at Day 212	0.00 Score on a scale Standard Deviation 14.907	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Cognitive functional scales: Change at Day 240	11.11 Score on a scale Standard Deviation 9.623	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Cognitive functional scales: Change at Day 268	8.33 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Cognitive functional scales: Change at Day 296	-8.33 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Cognitive functional scales: Change at Day 324	0.00 Score on a scale Standard Deviation NA Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Social functional scales: Change at Day 7	-2.08 Score on a scale Standard Deviation 20.774	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Social functional scales: Change at Day 28	2.08 Score on a scale Standard Deviation 5.893	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Social functional scales: Change at Day 56	4.17 Score on a scale Standard Deviation 7.715	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Social functional scales: Change at Day 78	-2.08 Score on a scale Standard Deviation 16.517	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Social functional scales: Change at Day 100	4.17 Score on a scale Standard Deviation 19.416	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Social functional scales: Change at Day 128	0.00 Score on a scale Standard Deviation 8.909	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Social functional scales: Change at Day 156	0.00 Score on a scale Standard Deviation 15.430	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Social functional scales: Change at Day 184	6.25 Score on a scale Standard Deviation 12.400	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Social functional scales: Change at Day 212	0.00 Score on a scale Standard Deviation 10.541	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Social functional scales: Change at Day 240	11.11 Score on a scale Standard Deviation 9.623	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Social functional scales: Change at Day 268	16.67 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Social functional scales: Change at Day 296	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Social functional scales: Change at Day 324	33.33 Score on a scale Standard Deviation NA Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Global health status scale: Change at Day 7	-8.33 Score on a scale Standard Deviation 15.430	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Global health status scale: Change at Day 28	-13.54 Score on a scale Standard Deviation 30.190	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Global health status scale: Change at Day 56	-4.17 Score on a scale Standard Deviation 17.817	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Global health status scale: Change at Day 78	-6.25 Score on a scale Standard Deviation 8.626	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Global health status scale: Change at Day 100	-2.08 Score on a scale Standard Deviation 13.176	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Global health status scale: Change at Day 128	-3.13 Score on a scale Standard Deviation 17.783	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Global health status scale: Change at Day 156	-3.13 Score on a scale Standard Deviation 14.042	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Global health status scale: Change at Day 184	-5.21 Score on a scale Standard Deviation 13.317	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Global health status scale: Change at Day 212	-2.78 Score on a scale Standard Deviation 6.804	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Global health status scale: Change at Day 240	5.56 Score on a scale Standard Deviation 12.729	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Global health status scale: Change at Day 268	12.50 Score on a scale Standard Deviation 5.893	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Global health status scale: Change at Day 296	-4.17 Score on a scale Standard Deviation 17.678	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Global health status scale: Change at Day 324	16.67 Score on a scale Standard Deviation NA Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Pain symptom scales: Change at Day 7	20.83 Score on a scale Standard Deviation 30.538	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Pain symptom scales: Change at Day 28	-2.08 Score on a scale Standard Deviation 10.681	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Pain symptom scales: Change at Day 56	8.33 Score on a scale Standard Deviation 17.817	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Pain symptom scales: Change at Day 78	4.17 Score on a scale Standard Deviation 14.773	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Pain symptom scales: Change at Day 100	2.08 Score on a scale Standard Deviation 10.681	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Pain symptom scales: Change at Day 128	4.17 Score on a scale Standard Deviation 19.416	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Pain symptom scales: Change at Day 156	0.00 Score on a scale Standard Deviation 12.599	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Pain symptom scales: Change at Day 184	2.08 Score on a scale Standard Deviation 5.893	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Pain symptom scales: Change at Day 212	-2.78 Score on a scale Standard Deviation 12.546	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Pain symptom scales: Change at Day 240	-5.56 Score on a scale Standard Deviation 9.623	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Pain symptom scales: Change at Day 268	-8.33 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Pain symptom scales: Change at Day 296	0.00 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Pain symptom scales: Change at Day 324	0.00 Score on a scale Standard Deviation NA Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Fatigue symptom scales: Change at Day 7	4.17 Score on a scale Standard Deviation 30.825	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Fatigue symptom scales: Change at Day 28	1.39 Score on a scale Standard Deviation 13.849	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Fatigue symptom scales: Change at Day 56	6.94 Score on a scale Standard Deviation 10.179	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Fatigue symptom scales: Change at Day 78	6.94 Score on a scale Standard Deviation 13.197	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Fatigue symptom scales: Change at Day 100	2.78 Score on a scale Standard Deviation 9.849	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Fatigue symptom scales: Change at Day 128	6.94 Score on a scale Standard Deviation 19.642	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Fatigue symptom scales: Change at Day 184	0.00 Score on a scale Standard Deviation 5.939	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Fatigue symptom scales: Change at Day 212	-5.56 Score on a scale Standard Deviation 9.296	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Fatigue symptom scales: Change at Day 240	3.70 Score on a scale Standard Deviation 35.717	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Fatigue symptom scales: Change at Day 268	0.00 Score on a scale Standard Deviation 15.713	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Fatigue symptom scales: Change at Day 296	16.67 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Fatigue symptom scales: Change at Day 324	11.11 Score on a scale Standard Deviation NA Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Nausea/vomiting symptom scales: Change at Day 7	14.58 Score on a scale Standard Deviation 18.767	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Nausea/vomiting symptom scales: Change at Day 28	2.08 Score on a scale Standard Deviation 5.893	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Nausea/vomiting symptom scales: Change at Day 56	2.08 Score on a scale Standard Deviation 5.893	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Nausea/vomiting symptom scales: Change at Day 78	2.08 Score on a scale Standard Deviation 5.893	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Nausea/vomiting symptom scales: Change at Day 100	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Nausea/vomiting symptom scales: Change at Day 128	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Nausea/vomiting symptom scales: Change at Day 156	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Nausea/vomiting symptom scales: Change at Day 184	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Nausea/vomiting symptom scales: Change at Day 212	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Nausea/vomiting symptom scales: Change at Day 240	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Nausea/vomiting symptom scales: Change at Day 268	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Nausea/vomiting symptom scales: Change at Day 296	0.00 Score on a scale Standard Deviation 47.140	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Nausea/vomiting symptom scales: Change at Day 324	0.00 Score on a scale Standard Deviation NA Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Dyspnea: Change at Day 7	4.17 Score on a scale Standard Deviation 45.207	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Dyspnea: Change at Day 28	-12.50 Score on a scale Standard Deviation 24.801	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Dyspnea: Change at Day 56	-4.17 Score on a scale Standard Deviation 21.362	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Dyspnea: Change at Day 78	8.33 Score on a scale Standard Deviation 29.547	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Dyspnea: Change at Day 100	0.00 Score on a scale Standard Deviation 17.817	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Dyspnea: Change at Day 128	-8.33 Score on a scale Standard Deviation 15.430	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Dyspnea: Change at Day 184	-12.50 Score on a scale Standard Deviation 24.801	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Dyspnea: Change at Day 212	-16.67 Score on a scale Standard Deviation 27.889	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Dyspnea: Change at Day 240	-11.11 Score on a scale Standard Deviation 38.490	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Dyspnea: Change at Day 268	0.00 Score on a scale Standard Deviation 47.140	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Dyspnea: Change at Day 296	0.00 Score on a scale Standard Deviation 47.140	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Dyspnea: Change at Day 324	33.33 Score on a scale Standard Deviation NA Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Insomnia: Change at Day 7	8.33 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Insomnia: Change at Day 28	-4.17 Score on a scale Standard Deviation 21.362	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Insomnia: Change at Day 56	-4.17 Score on a scale Standard Deviation 21.362	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Insomnia: Change at Day 78	0.00 Score on a scale Standard Deviation 17.817	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Insomnia: Change at Day 100	4.17 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Insomnia: Change at Day 128	-4.17 Score on a scale Standard Deviation 21.362	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Insomnia: Change at Day 156	-4.17 Score on a scale Standard Deviation 21.362	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Insomnia: Change at Day 184	-8.33 Score on a scale Standard Deviation 15.430	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Insomnia: Change at Day 212	0.00 Score on a scale Standard Deviation 21.082	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Insomnia: Change at Day 240	-11.11 Score on a scale Standard Deviation 19.245	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Insomnia: Change at Day 268	-16.67 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Insomnia: Change at Day 296	16.67 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Insomnia: Change at Day 324	0.00 Score on a scale	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Appetite loss: Change at Day 7	20.83 Score on a scale Standard Deviation 24.801	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Appetite loss: Change at Day 28	16.67 Score on a scale Standard Deviation 17.817	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Appetite loss: Change at Day 56	4.17 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Appetite loss: Change at Day 78	8.33 Score on a scale Standard Deviation 15.430	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Appetite loss: Change at Day 100	4.17 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Appetite loss: Change at Day 128	16.67 Score on a scale Standard Deviation 25.198	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Appetite loss: Change at Day 156	4.17 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Appetite loss: Change at Day 184	4.17 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Appetite loss: Change at Day 212	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Appetite loss: Change at Day 240	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Appetite loss: Change at Day 268	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Appetite loss: Change at Day 296	16.67 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Appetite loss: Change at Day 324	-33.33 Score on a scale Standard Deviation NA Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Constipation: Change at Day 7	0.00 Score on a scale Standard Deviation 17.817	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Constipation: Change at Day 28	-4.17 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Constipation: Change at Day 56	0.00 Score on a scale Standard Deviation 17.817	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Constipation: Change at Day 78	-4.17 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Constipation: Change at Day 100	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Constipation: Change at Day 128	-4.17 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Constipation: Change at Day 156	-4.17 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Constipation: Change at Day 184	-4.17 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Constipation: Change at Day 212	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Constipation: Change at Day 240	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Constipation: Change at Day 268	16.67 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Constipation: Change at Day 296	50.00 Score on a scale Standard Deviation 70.711	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Constipation: Change at Day 324	0.00 Score on a scale Standard Deviation NA Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Diarrhea: Change at Day 7	8.33 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Diarrhea: Change at Day 28	0.00 Score on a scale Standard Deviation 25.198	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Diarrhea: Change at Day 56	-12.50 Score on a scale Standard Deviation 24.801	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Diarrhea: Change at Day 78	-12.50 Score on a scale Standard Deviation 24.801	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Diarrhea: Change at Day 100	0.00 Score on a scale Standard Deviation 35.635	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Diarrhea: Change at Day 128	-8.33 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Diarrhea: Change at Day 156	-8.33 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Diarrhea: Change at Day 184	-8.33 Score on a scale Standard Deviation 15.430	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Diarrhea: Change at Day 212	0.00 Score on a scale Standard Deviation 21.082	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Diarrhea: Change at Day 240	11.11 Score on a scale Standard Deviation 19.245	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Diarrhea: Change at Day 268	33.33 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Diarrhea: Change at Day 296	-16.67 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Diarrhea: Change at Day 324	33.33 Score on a scale Standard Deviation NA Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Financial difficulties: Change at Day 7	-4.17 Score on a scale Standard Deviation 21.362	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Financial difficulties: Change at Day 28	-4.17 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Financial difficulties: Change at Day 56	-12.50 Score on a scale Standard Deviation 17.252	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Financial difficulties: Change at Day 78	-8.33 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Financial difficulties: Change at Day 100	-12.50 Score on a scale Standard Deviation 17.252	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Financial difficulties: Change at Day 128	0.00 Score on a scale Standard Deviation 30.861	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Financial difficulties: Change at Day 156	-12.50 Score on a scale Standard Deviation 17.252	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Financial difficulties: Change at Day 184	-12.50 Score on a scale Standard Deviation 17.252	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Financial difficulties: Change at Day 240	0.00 Score on a scale Standard Deviation 33.333	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Financial difficulties: Change at Day 268	-16.67 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Financial difficulties: Change at Day 296	-16.67 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Financial difficulties: Change at Day 324	-33.33 Score on a scale Standard Deviation NA Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.	—	—

SECONDARY outcome

Timeframe: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380

PGIS was a single item to assess severity of pain on a 5-point verbal rating scale ranged from 1 (no pain) to 5 (very severe pain), where 1: none; 2: mild; 3: moderate; 4: severe; 5: very severe. A higher score indicated a more severe pain.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=54 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=8 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 Change at Day 7	-0.3 Score on a scale Standard Deviation 0.96	0.3 Score on a scale Standard Deviation 0.71	—
Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 Change at Day 56	-0.3 Score on a scale Standard Deviation 0.79	0.3 Score on a scale Standard Deviation 0.46	—
Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 Change at Day 28	-0.3 Score on a scale Standard Deviation 0.94	-0.1 Score on a scale Standard Deviation 0.64	—
Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 Change at Day 78	-0.3 Score on a scale Standard Deviation 0.87	0.0 Score on a scale Standard Deviation 0.53	—
Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 Change at Day 100	-0.3 Score on a scale Standard Deviation 0.93	0.0 Score on a scale Standard Deviation 0.53	—
Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 Change at Day 128	-0.3 Score on a scale Standard Deviation 1.06	0.0 Score on a scale Standard Deviation 0.53	—
Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 Change at Day 156	-0.4 Score on a scale Standard Deviation 0.90	0.0 Score on a scale Standard Deviation 0.93	—
Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 Change at Day 184	-0.3 Score on a scale Standard Deviation 1.06	0.3 Score on a scale Standard Deviation 0.46	—
Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 Change at Day 212	-0.2 Score on a scale Standard Deviation 0.97	0.0 Score on a scale Standard Deviation 0.63	—
Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 Change at Day 240	-0.3 Score on a scale Standard Deviation 0.86	0.0 Score on a scale Standard Deviation 0.00	—
Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 Change at Day 268	-0.5 Score on a scale Standard Deviation 0.93	0.0 Score on a scale Standard Deviation NA Here, 'NA' signifies that SD could not be calculated as only 1 participant was evaluated.	—
Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 Change at Day 296	-0.2 Score on a scale Standard Deviation 1.20	0.0 Score on a scale Standard Deviation 0.00	—
Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 Change at Day 324	-0.6 Score on a scale Standard Deviation 1.12	0.0 Score on a scale Standard Deviation NA Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.	—
Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 Change at Day 352	-0.9 Score on a scale Standard Deviation 1.21	—	—
Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 Change at Day 380	-0.5 Score on a scale Standard Deviation 0.71	—	—

SECONDARY outcome

Timeframe: Days 28, 56, 78, 100

PGIC was a single item to assess the participant's perception in change of their overall health status using a 7-point verbal rating scale ranging from 1(a lot better now) to 7 (a lot verse now), where 1: a lot better now; 2: moderately better now; 3: a little better now; 4: neither better nor worse; 5: a little worse now; 6: moderately worse now; 7: a lot worse now. Higher score indicated worse health status.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=54 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) n=8 Participants Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 2: Patient Global Impression of Change (PGIC) Score at Days 28, 56, 78, 100 Change at Day 78	2.2 Score on a scale Standard Deviation 1.51	2.5 Score on a scale Standard Deviation 0.93	—
Phase 2: Patient Global Impression of Change (PGIC) Score at Days 28, 56, 78, 100 Change at Day 28	2.7 Score on a scale Standard Deviation 1.63	2.8 Score on a scale Standard Deviation 0.89	—
Phase 2: Patient Global Impression of Change (PGIC) Score at Days 28, 56, 78, 100 Change at Day 56	2.5 Score on a scale Standard Deviation 1.66	2.9 Score on a scale Standard Deviation 1.25	—
Phase 2: Patient Global Impression of Change (PGIC) Score at Days 28, 56, 78, 100 Change at Day 100	2.0 Score on a scale Standard Deviation 1.43	2.4 Score on a scale Standard Deviation 0.79	—

SECONDARY outcome

Timeframe: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380

EORTC QLQ-MY20 scale comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (includes bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity), side effects of treatment (includes drowsiness, thirst, feeling ill, dry mouth, hair loss, upset by hair loss, tingling hands or feet, restlessness/agitation, acid indigestion/heartburn, and burning or sore eyes), future perspective (includes worry about death and health in the future, and thinking about illness) and body image. The scale was administered to assess 4 single items: feel restless or agitated, thinking about your illness, worried about dying, worried about health in the future. Scores were averaged and scales were transformed on a 0 to 100 scale. A high score for side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective represented better outcomes.

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=54 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Restless or agitated: Change at Day 28	-5.5 Score on a scale Interval -10.7 to -0.3	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Restless or agitated: Change at Day 184	-3.6 Score on a scale Interval -9.4 to 2.1	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Thinking about illness: Change at Day 56	17.1 Score on a scale Interval 10.8 to 23.3	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about dying: Change at Day 296	16.3 Score on a scale Interval 10.8 to 21.8	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about health in future: Change at Day 78	19.7 Score on a scale Interval 13.4 to 26.0	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Restless or agitated: Change at Day 7	5.7 Score on a scale Interval 0.6 to 10.8	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Restless or agitated: Change at Day 56	1.6 Score on a scale Interval -3.6 to 6.7	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Restless or agitated: Change at Day 78	-2.7 Score on a scale Interval -8.1 to 2.8	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Restless or agitated: Change at Day 100	-3.3 Score on a scale Interval -8.6 to 2.0	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Restless or agitated: Change at Day 128	-3.9 Score on a scale Interval -9.6 to 1.9	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Restless or agitated: Change at Day 156	0.9 Score on a scale Interval -5.0 to 6.9	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Restless or agitated: Change at Day 212	-3.9 Score on a scale Interval -10.1 to 2.3	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Restless or agitated: Change at Day 240	-12.7 Score on a scale Interval -19.0 to -6.5	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Restless or agitated: Change at Day 268	-1.7 Score on a scale Interval -7.8 to 4.3	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Restless or agitated: Change at Day 296	-7.8 Score on a scale Interval -14.0 to -1.5	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Restless or agitated: Change at Day 324	-11.5 Score on a scale Interval -20.4 to -2.5	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Restless or agitated: Change at Day 352	1.1 Score on a scale Interval -11.1 to 13.4	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Restless or agitated: Change at Day 380	-23.2 Score on a scale Interval -45.8 to -0.6	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Thinking about illness: Change at Day 7	7.8 Score on a scale Interval 1.7 to 14.0	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Thinking about illness: Change at Day 28	15 Score on a scale Interval 8.8 to 21.2	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Thinking about illness: Change at Day 78	23.1 Score on a scale Interval 16.7 to 29.6	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Thinking about illness: Change at Day 100	25.7 Score on a scale Interval 19.4 to 32.0	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Thinking about illness: Change at Day 128	27.6 Score on a scale Interval 20.8 to 34.3	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Thinking about illness: Change at Day 156	29.9 Score on a scale Interval 22.8 to 36.9	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Thinking about illness: Change at Day 184	27.9 Score on a scale Interval 21.2 to 34.7	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Thinking about illness: Change at Day 212	34.7 Score on a scale Interval 27.5 to 41.8	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Thinking about illness: Change at Day 240	32.1 Score on a scale Interval 24.8 to 39.3	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Thinking about illness: Change at Day 268	34.9 Score on a scale Interval 27.8 to 41.9	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Thinking about illness: Change at Day 296	32.6 Score on a scale Interval 25.3 to 39.8	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Thinking about illness: Change at Day 324	35.1 Score on a scale Interval 25.3 to 45.0	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Thinking about illness: Change at Day 352	33.5 Score on a scale Interval 20.3 to 46.8	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Thinking about illness: Change at Day 380	34.3 Score on a scale Interval 10.2 to 58.4	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about dying: Change at Day 7	13.2 Score on a scale Interval 8.5 to 17.8	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about dying: Change at Day 28	18.2 Score on a scale Interval 13.6 to 22.9	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about dying: Change at Day 56	16.8 Score on a scale Interval 12.1 to 21.5	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about dying: Change at Day 78	18.3 Score on a scale Interval 13.4 to 23.1	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about dying: Change at Day 100	18.9 Score on a scale Interval 14.1 to 23.7	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about dying: Change at Day 128	16.8 Score on a scale Interval 11.7 to 21.9	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about dying: Change at Day 156	14.9 Score on a scale Interval 9.6 to 20.2	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about dying: Change at Day 184	15.8 Score on a scale Interval 10.7 to 21.0	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about dying: Change at Day 212	13.3 Score on a scale Interval 7.9 to 18.8	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about dying: Change at Day 240	14.7 Score on a scale Interval 9.1 to 20.2	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about dying: Change at Day 268	10 Score on a scale Interval 4.7 to 15.4	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about dying: Change at Day 324	17.6 Score on a scale Interval 9.9 to 25.3	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about dying: Change at Day 352	14.9 Score on a scale Interval 4.5 to 25.3	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about dying: Change at Day 380	27.1 Score on a scale Interval 8.0 to 46.1	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about health in future: Change at Day 7	8.2 Score on a scale Interval 2.2 to 14.2	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about health in future: Change at Day 28	18.2 Score on a scale Interval 12.2 to 24.2	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about health in future: Change at Day 56	15.5 Score on a scale Interval 9.4 to 21.5	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about health in future: Change at Day 100	14.3 Score on a scale Interval 8.1 to 20.4	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about health in future: Change at Day 128	20.4 Score on a scale Interval 13.8 to 26.9	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about health in future: Change at Day 156	18.9 Score on a scale Interval 12.0 to 25.7	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about health in future: Change at Day 184	19 Score on a scale Interval 12.3 to 25.6	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about health in future: Change at Day 212	19.9 Score on a scale Interval 12.9 to 26.9	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about health in future: Change at Day 240	19.7 Score on a scale Interval 12.6 to 26.8	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about health in future: Change at Day 268	17.1 Score on a scale Interval 10.2 to 23.9	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about health in future: Change at Day 296	24.2 Score on a scale Interval 17.2 to 31.3	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about health in future: Change at Day 324	20.2 Score on a scale Interval 10.5 to 29.8	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about health in future: Change at Day 352	25.1 Score on a scale Interval 12.1 to 38.0	—	—
Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 Worried about health in future: Change at Day 380	7.7 Score on a scale Interval -15.8 to 31.2	—	—

SECONDARY outcome

Timeframe: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324

Outcome measures

Outcome measures
Measure	Phase 1b (US Population) n=8 Participants Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\10\^6 CAR-positive viable cells/kg) as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.	Phase 2 (Japan Population) Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about health in future: Change at Day 7	0.00 Score on a scale Standard Deviation 17.817	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about health in future: Change at Day 56	4.17 Score on a scale Standard Deviation 21.362	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about health in future: Change at Day 78	4.17 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about health in future: Change at Day 156	4.17 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about health in future: Change at Day 28	-4.17 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about health in future: Change at Day 100	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about health in future: Change at Day 128	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about health in future: Change at Day 184	8.33 Score on a scale Standard Deviation 15.430	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about health in future: Change at Day 212	5.56 Score on a scale Standard Deviation 13.608	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about health in future: Change at Day 240	22.22 Score on a scale Standard Deviation 19.245	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about health in future: Change at Day 268	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about health in future: Change at Day 296	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about health in future: Change at Day 324	0.00 Score on a scale	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Restless or agitated: Change at Day 7	12.50 Score on a scale Standard Deviation 17.252	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Restless or agitated: Change at Day 28	8.33 Score on a scale Standard Deviation 15.430	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Restless or agitated: Change at Day 56	0.00 Score on a scale Standard Deviation 25.198	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Restless or agitated: Change at Day 78	0.00 Score on a scale Standard Deviation 17.817	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Restless or agitated: Change at Day 100	0.00 Score on a scale Standard Deviation 17.817	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Restless or agitated: Change at Day 128	0.00 Score on a scale Standard Deviation 25.198	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Restless or agitated: Change at Day 156	-8.33 Score on a scale Standard Deviation 15.430	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Restless or agitated: Change at Day 184	-4.17 Score on a scale Standard Deviation 21.362	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Restless or agitated: Change at Day 212	-5.56 Score on a scale Standard Deviation 13.608	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Restless or agitated: Change at Day 240	-11.11 Score on a scale Standard Deviation 19.245	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Restless or agitated: Change at Day 268	-16.67 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Restless or agitated: Change at Day 296	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Restless or agitated: Change at Day 324	-33.33 Score on a scale Standard Deviation NA SD could not be calculated as only 1 participant was analyzed.	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Thinking about illness: Change at Day 7	4.17 Score on a scale Standard Deviation 33.034	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Thinking about illness: Change at Day 28	-4.17 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Thinking about illness: Change at Day 56	8.33 Score on a scale Standard Deviation 15.430	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Thinking about illness: Change at Day 78	4.17 Score on a scale Standard Deviation 11.785	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Thinking about illness: Change at Day 100	8.33 Score on a scale Standard Deviation 15.430	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Thinking about illness: Change at Day 128	8.33 Score on a scale Standard Deviation 15.430	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Thinking about illness: Change at Day 156	12.50 Score on a scale Standard Deviation 24.801	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Thinking about illness: Change at Day 184	12.50 Score on a scale Standard Deviation 17.252	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Thinking about illness: Change at Day 212	22.22 Score on a scale Standard Deviation 27.217	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Thinking about illness: Change at Day 240	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Thinking about illness: Change at Day 268	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Thinking about illness: Change at Day 296	0.00 Score on a scale Standard Deviation 0.000	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Thinking about illness: Change at Day 324	0.00 Score on a scale	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about dying: Change at Day 7	16.67 Score on a scale Standard Deviation 17.817	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about dying: Change at Day 28	8.33 Score on a scale Standard Deviation 15.430	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about dying: Change at Day 56	16.67 Score on a scale Standard Deviation 25.198	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about dying: Change at Day 78	25.00 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about dying: Change at Day 100	25.00 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about dying: Change at Day 128	25.00 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about dying: Change at Day 156	20.83 Score on a scale Standard Deviation 24.801	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about dying: Change at Day 184	29.17 Score on a scale Standard Deviation 21.362	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about dying: Change at Day 212	27.78 Score on a scale Standard Deviation 25.092	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about dying: Change at Day 240	11.11 Score on a scale Standard Deviation 19.245	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about dying: Change at Day 268	16.67 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about dying: Change at Day 296	16.67 Score on a scale Standard Deviation 23.570	—	—
Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 Worried about dying: Change at Day 324	0.00 Score on a scale	—	—

Adverse Events

Phase 1b (US Population)

Serious events: 11 serious events

Other events: 29 other events

Deaths: 10 deaths

Phase 2 (US Population)

Serious events: 42 serious events

Other events: 68 other events

Deaths: 25 deaths

Phase 2 (Japan Population)

Serious events: 1 serious events

Other events: 9 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Vice President Research and Development, Cellular Therapy

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER