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NCT03548207 · OUTCOME

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

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 · Source last updated 2025-07-30

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

Measure: MEAN
Unit: Score on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324

What was measured

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.

Analysis 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 and "n" (number analyzed) signifies those participants who were evaluable for specified time points.

Groups in this outcome

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.

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

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Reported measurements

Physical functional scales: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2.50	12.312	Not reported	Not reported	Not reported

Physical functional scales: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.17	10.040	Not reported	Not reported	Not reported

Physical functional scales: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-1.67	6.901	Not reported	Not reported	Not reported

Physical functional scales: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	3.563	Not reported	Not reported	Not reported

Physical functional scales: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-1.67	5.909	Not reported	Not reported	Not reported

Physical functional scales: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-0.83	8.309	Not reported	Not reported	Not reported

Physical functional scales: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.83	6.607	Not reported	Not reported	Not reported

Physical functional scales: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.17	4.960	Not reported	Not reported	Not reported

Physical functional scales: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	6

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.44	5.443	Not reported	Not reported	Not reported

Physical functional scales: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	3

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.44	7.698	Not reported	Not reported	Not reported

Physical functional scales: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-3.33	4.714	Not reported	Not reported	Not reported

Physical functional scales: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	0.000	Not reported	Not reported	Not reported

Physical functional scales: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	1

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	Not reported	Not reported	Not reported	Not reported

Role functional scales: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-10.42	15.269	Not reported	Not reported	Not reported

Role functional scales: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-8.33	17.817	Not reported	Not reported	Not reported

Role functional scales: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-12.50	17.252	Not reported	Not reported	Not reported

Role functional scales: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-6.25	26.633	Not reported	Not reported	Not reported

Role functional scales: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-6.25	15.269	Not reported	Not reported	Not reported

Role functional scales: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-16.67	26.726	Not reported	Not reported	Not reported

Role functional scales: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-10.42	26.633	Not reported	Not reported	Not reported

Role functional scales: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-10.42	29.463	Not reported	Not reported	Not reported

Role functional scales: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	6

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-8.33	20.412	Not reported	Not reported	Not reported

Role functional scales: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	3

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-11.11	19.245	Not reported	Not reported	Not reported

Role functional scales: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-8.33	11.785	Not reported	Not reported	Not reported

Role functional scales: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-16.67	23.570	Not reported	Not reported	Not reported

Role functional scales: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	1

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-16.67	NA	Not reported	Not reported	Standard deviation (SD) could not be calculated as only 1 participant was available.

Emotional functional scales: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.08	9.708	Not reported	Not reported	Not reported

Emotional functional scales: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	1.04	8.259	Not reported	Not reported	Not reported

Emotional functional scales: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	6.25	8.626	Not reported	Not reported	Not reported

Emotional functional scales: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.17	9.960	Not reported	Not reported	Not reported

Emotional functional scales: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	5.21	8.839	Not reported	Not reported	Not reported

Emotional functional scales: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	3.13	11.732	Not reported	Not reported	Not reported

Emotional functional scales: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	5.21	9.898	Not reported	Not reported	Not reported

Emotional functional scales: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	9.38	6.954	Not reported	Not reported	Not reported

Emotional functional scales: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	6

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.78	6.804	Not reported	Not reported	Not reported

Emotional functional scales: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	3

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	11.11	9.623	Not reported	Not reported	Not reported

Emotional functional scales: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	8.33	11.785	Not reported	Not reported	Not reported

Emotional functional scales: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.17	5.893	Not reported	Not reported	Not reported

Emotional functional scales: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	1

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	16.67	NA	Not reported	Not reported	Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.

Cognitive functional scales: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.17	11.785	Not reported	Not reported	Not reported

Cognitive functional scales: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.08	5.893	Not reported	Not reported	Not reported

Cognitive functional scales: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.17	14.773	Not reported	Not reported	Not reported

Cognitive functional scales: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	12.599	Not reported	Not reported	Not reported

Cognitive functional scales: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2.08	10.681	Not reported	Not reported	Not reported

Cognitive functional scales: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.17	11.785	Not reported	Not reported	Not reported

Cognitive functional scales: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	15.430	Not reported	Not reported	Not reported

Cognitive functional scales: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.08	13.909	Not reported	Not reported	Not reported

Cognitive functional scales: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	6

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	14.907	Not reported	Not reported	Not reported

Cognitive functional scales: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	3

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	11.11	9.623	Not reported	Not reported	Not reported

Cognitive functional scales: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	8.33	11.785	Not reported	Not reported	Not reported

Cognitive functional scales: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-8.33	11.785	Not reported	Not reported	Not reported

Cognitive functional scales: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	1

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	NA	Not reported	Not reported	Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.

Social functional scales: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2.08	20.774	Not reported	Not reported	Not reported

Social functional scales: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.08	5.893	Not reported	Not reported	Not reported

Social functional scales: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.17	7.715	Not reported	Not reported	Not reported

Social functional scales: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2.08	16.517	Not reported	Not reported	Not reported

Social functional scales: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.17	19.416	Not reported	Not reported	Not reported

Social functional scales: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	8.909	Not reported	Not reported	Not reported

Social functional scales: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	15.430	Not reported	Not reported	Not reported

Social functional scales: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	6.25	12.400	Not reported	Not reported	Not reported

Social functional scales: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	6

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	10.541	Not reported	Not reported	Not reported

Social functional scales: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	3

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	11.11	9.623	Not reported	Not reported	Not reported

Social functional scales: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	16.67	23.570	Not reported	Not reported	Not reported

Social functional scales: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	0.000	Not reported	Not reported	Not reported

Social functional scales: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	1

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	33.33	NA	Not reported	Not reported	Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.

Global health status scale: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-8.33	15.430	Not reported	Not reported	Not reported

Global health status scale: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-13.54	30.190	Not reported	Not reported	Not reported

Global health status scale: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.17	17.817	Not reported	Not reported	Not reported

Global health status scale: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-6.25	8.626	Not reported	Not reported	Not reported

Global health status scale: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2.08	13.176	Not reported	Not reported	Not reported

Global health status scale: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-3.13	17.783	Not reported	Not reported	Not reported

Global health status scale: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-3.13	14.042	Not reported	Not reported	Not reported

Global health status scale: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-5.21	13.317	Not reported	Not reported	Not reported

Global health status scale: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	6

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2.78	6.804	Not reported	Not reported	Not reported

Global health status scale: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	3

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	5.56	12.729	Not reported	Not reported	Not reported

Global health status scale: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	12.50	5.893	Not reported	Not reported	Not reported

Global health status scale: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.17	17.678	Not reported	Not reported	Not reported

Global health status scale: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	1

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	16.67	NA	Not reported	Not reported	Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.

Pain symptom scales: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	20.83	30.538	Not reported	Not reported	Not reported

Pain symptom scales: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2.08	10.681	Not reported	Not reported	Not reported

Pain symptom scales: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	8.33	17.817	Not reported	Not reported	Not reported

Pain symptom scales: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.17	14.773	Not reported	Not reported	Not reported

Pain symptom scales: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.08	10.681	Not reported	Not reported	Not reported

Pain symptom scales: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.17	19.416	Not reported	Not reported	Not reported

Pain symptom scales: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	12.599	Not reported	Not reported	Not reported

Pain symptom scales: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.08	5.893	Not reported	Not reported	Not reported

Pain symptom scales: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	6

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2.78	12.546	Not reported	Not reported	Not reported

Pain symptom scales: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	3

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-5.56	9.623	Not reported	Not reported	Not reported

Pain symptom scales: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-8.33	11.785	Not reported	Not reported	Not reported

Pain symptom scales: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	23.570	Not reported	Not reported	Not reported

Pain symptom scales: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	1

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	NA	Not reported	Not reported	Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.

Fatigue symptom scales: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.17	30.825	Not reported	Not reported	Not reported

Fatigue symptom scales: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	1.39	13.849	Not reported	Not reported	Not reported

Fatigue symptom scales: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	6.94	10.179	Not reported	Not reported	Not reported

Fatigue symptom scales: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	6.94	13.197	Not reported	Not reported	Not reported

Fatigue symptom scales: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.78	9.849	Not reported	Not reported	Not reported

Fatigue symptom scales: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	6.94	19.642	Not reported	Not reported	Not reported

Fatigue symptom scales: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.78	7.857	Not reported	Not reported	Not reported

Fatigue symptom scales: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	5.939	Not reported	Not reported	Not reported

Fatigue symptom scales: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	6

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-5.56	9.296	Not reported	Not reported	Not reported

Fatigue symptom scales: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	3

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	3.70	35.717	Not reported	Not reported	Not reported

Fatigue symptom scales: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	15.713	Not reported	Not reported	Not reported

Fatigue symptom scales: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	16.67	23.570	Not reported	Not reported	Not reported

Fatigue symptom scales: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	1

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	11.11	NA	Not reported	Not reported	Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.

Nausea/vomiting symptom scales: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	14.58	18.767	Not reported	Not reported	Not reported

Nausea/vomiting symptom scales: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.08	5.893	Not reported	Not reported	Not reported

Nausea/vomiting symptom scales: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.08	5.893	Not reported	Not reported	Not reported

Nausea/vomiting symptom scales: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.08	5.893	Not reported	Not reported	Not reported

Nausea/vomiting symptom scales: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	0.000	Not reported	Not reported	Not reported

Nausea/vomiting symptom scales: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	0.000	Not reported	Not reported	Not reported

Nausea/vomiting symptom scales: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	0.000	Not reported	Not reported	Not reported

Nausea/vomiting symptom scales: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	0.000	Not reported	Not reported	Not reported

Nausea/vomiting symptom scales: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	6

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	0.000	Not reported	Not reported	Not reported

Nausea/vomiting symptom scales: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	3

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	0.000	Not reported	Not reported	Not reported

Nausea/vomiting symptom scales: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	0.000	Not reported	Not reported	Not reported

Nausea/vomiting symptom scales: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	47.140	Not reported	Not reported	Not reported

Nausea/vomiting symptom scales: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	1

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	NA	Not reported	Not reported	Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.

Dyspnea: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.17	45.207	Not reported	Not reported	Not reported

Dyspnea: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-12.50	24.801	Not reported	Not reported	Not reported

Dyspnea: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.17	21.362	Not reported	Not reported	Not reported

Dyspnea: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	8.33	29.547	Not reported	Not reported	Not reported

Dyspnea: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	17.817	Not reported	Not reported	Not reported

Dyspnea: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-8.33	15.430	Not reported	Not reported	Not reported

Dyspnea: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-12.50	24.801	Not reported	Not reported	Not reported

Dyspnea: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-12.50	24.801	Not reported	Not reported	Not reported

Dyspnea: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	6

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-16.67	27.889	Not reported	Not reported	Not reported

Dyspnea: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	3

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-11.11	38.490	Not reported	Not reported	Not reported

Dyspnea: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	47.140	Not reported	Not reported	Not reported

Dyspnea: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	47.140	Not reported	Not reported	Not reported

Dyspnea: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	1

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	33.33	NA	Not reported	Not reported	Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.

Insomnia: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	8.33	23.570	Not reported	Not reported	Not reported

Insomnia: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.17	21.362	Not reported	Not reported	Not reported

Insomnia: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.17	21.362	Not reported	Not reported	Not reported

Insomnia: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	17.817	Not reported	Not reported	Not reported

Insomnia: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.17	11.785	Not reported	Not reported	Not reported

Insomnia: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.17	21.362	Not reported	Not reported	Not reported

Insomnia: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.17	21.362	Not reported	Not reported	Not reported

Insomnia: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-8.33	15.430	Not reported	Not reported	Not reported

Insomnia: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	6

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	21.082	Not reported	Not reported	Not reported

Insomnia: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	3

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-11.11	19.245	Not reported	Not reported	Not reported

Insomnia: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-16.67	23.570	Not reported	Not reported	Not reported

Insomnia: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	16.67	23.570	Not reported	Not reported	Not reported

Insomnia: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	1

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	Not reported	Not reported	Not reported	Not reported

Appetite loss: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	20.83	24.801	Not reported	Not reported	Not reported

Appetite loss: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	16.67	17.817	Not reported	Not reported	Not reported

Appetite loss: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.17	11.785	Not reported	Not reported	Not reported

Appetite loss: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	8.33	15.430	Not reported	Not reported	Not reported

Appetite loss: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.17	11.785	Not reported	Not reported	Not reported

Appetite loss: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	16.67	25.198	Not reported	Not reported	Not reported

Appetite loss: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.17	11.785	Not reported	Not reported	Not reported

Appetite loss: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.17	11.785	Not reported	Not reported	Not reported

Appetite loss: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	6

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	0.000	Not reported	Not reported	Not reported

Appetite loss: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	3

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	0.000	Not reported	Not reported	Not reported

Appetite loss: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	3

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	0.000	Not reported	Not reported	Not reported

Appetite loss: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	16.67	23.570	Not reported	Not reported	Not reported

Appetite loss: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	1

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-33.33	NA	Not reported	Not reported	Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.

Constipation: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	17.817	Not reported	Not reported	Not reported

Constipation: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.17	11.785	Not reported	Not reported	Not reported

Constipation: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	17.817	Not reported	Not reported	Not reported

Constipation: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.17	11.785	Not reported	Not reported	Not reported

Constipation: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	0.000	Not reported	Not reported	Not reported

Constipation: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.17	11.785	Not reported	Not reported	Not reported

Constipation: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.17	11.785	Not reported	Not reported	Not reported

Constipation: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.17	11.785	Not reported	Not reported	Not reported

Constipation: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	6

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	0.000	Not reported	Not reported	Not reported

Constipation: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	3

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	0.000	Not reported	Not reported	Not reported

Constipation: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	16.67	23.570	Not reported	Not reported	Not reported

Constipation: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	50.00	70.711	Not reported	Not reported	Not reported

Constipation: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	1

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	NA	Not reported	Not reported	Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.

Diarrhea: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	8.33	23.570	Not reported	Not reported	Not reported

Diarrhea: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	25.198	Not reported	Not reported	Not reported

Diarrhea: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-12.50	24.801	Not reported	Not reported	Not reported

Diarrhea: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-12.50	24.801	Not reported	Not reported	Not reported

Diarrhea: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	35.635	Not reported	Not reported	Not reported

Diarrhea: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-8.33	23.570	Not reported	Not reported	Not reported

Diarrhea: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-8.33	23.570	Not reported	Not reported	Not reported

Diarrhea: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-8.33	15.430	Not reported	Not reported	Not reported

Diarrhea: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	6

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	21.082	Not reported	Not reported	Not reported

Diarrhea: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	3

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	11.11	19.245	Not reported	Not reported	Not reported

Diarrhea: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	33.33	0.000	Not reported	Not reported	Not reported

Diarrhea: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-16.67	23.570	Not reported	Not reported	Not reported

Diarrhea: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	1

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	33.33	NA	Not reported	Not reported	Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.

Financial difficulties: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.17	21.362	Not reported	Not reported	Not reported

Financial difficulties: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.17	11.785	Not reported	Not reported	Not reported

Financial difficulties: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-12.50	17.252	Not reported	Not reported	Not reported

Financial difficulties: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-8.33	23.570	Not reported	Not reported	Not reported

Financial difficulties: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-12.50	17.252	Not reported	Not reported	Not reported

Financial difficulties: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	30.861	Not reported	Not reported	Not reported

Financial difficulties: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-12.50	17.252	Not reported	Not reported	Not reported

Financial difficulties: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-12.50	17.252	Not reported	Not reported	Not reported

Financial difficulties: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-11.11	27.217	Not reported	Not reported	Not reported

Financial difficulties: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.00	33.333	Not reported	Not reported	Not reported

Financial difficulties: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-16.67	23.570	Not reported	Not reported	Not reported

Financial difficulties: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-16.67	23.570	Not reported	Not reported	Not reported

Financial difficulties: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	8

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-33.33	NA	Not reported	Not reported	Here, 'NA' signifies that SD could not be calculated as only 1 participant was analyzed.

Complete source fields

classes

categories
measurements
group Id
OG000
spread
12.312
value
-2.50
denoms
counts
group Id
OG000
value
8
units
Participants
title
Physical functional scales: Change at Day 7
categories
measurements
group Id
OG000
spread
10.040
value
-4.17
denoms
counts
group Id
OG000
value
8
units
Participants
title
Physical functional scales: Change at Day 28
categories
measurements
group Id
OG000
spread
6.901
value
-1.67
denoms
counts
group Id
OG000
value
8
units
Participants
title
Physical functional scales: Change at Day 56
categories
measurements
group Id
OG000
spread
3.563
value
0.00
denoms
counts
group Id
OG000
value
8
units
Participants
title
Physical functional scales: Change at Day 78
categories
measurements
group Id
OG000
spread
5.909
value
-1.67
denoms
counts
group Id
OG000
value
8
units
Participants
title
Physical functional scales: Change at Day 100
categories
measurements
group Id
OG000
spread
8.309
value
-0.83
denoms
counts
group Id
OG000
value
8
units
Participants
title
Physical functional scales: Change at Day 128
categories
measurements
group Id
OG000
spread
6.607
value
0.83
denoms
counts
group Id
OG000
value
8
units
Participants
title
Physical functional scales: Change at Day 156
categories
measurements
group Id
OG000
spread
4.960
value
4.17
denoms
counts
group Id
OG000
value
8
units
Participants
title
Physical functional scales: Change at Day 184
categories
measurements
group Id
OG000
spread
5.443
value
4.44
denoms
counts
group Id
OG000
value
6
units
Participants
title
Physical functional scales: Change at Day 212
categories
measurements
group Id
OG000
spread
7.698
value
4.44
denoms
counts
group Id
OG000
value
3
units
Participants
title
Physical functional scales: Change at Day 240
categories
measurements
group Id
OG000
spread
4.714
value
-3.33
denoms
counts
group Id
OG000
value
2
units
Participants
title
Physical functional scales: Change at Day 268
categories
measurements
group Id
OG000
spread
0.000
value
0.00
denoms
counts
group Id
OG000
value
2
units
Participants
title
Physical functional scales: Change at Day 296

denoms

counts
group Id
OG000
value
8
units
Participants

description

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.

dispersion Type

Standard Deviation

groups

description
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.
id
OG000
title
Phase 2 (US Population)

param Type

MEAN

population Description

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 and "n" (number analyzed) signifies those participants who were evaluable for specified time points.

reporting Status

POSTED

time Frame

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

title

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

type

SECONDARY

unit Of Measure

Score on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice