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NCT03548207 · OUTCOME

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

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: LEAST_SQUARES_MEAN
Unit: Score on a scale
Interval / dispersion: 95% Confidence Interval
Time frame: Baseline, Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380

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)	54

Reported measurements

Physical functional scales: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	54

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-14.4	Not reported	-19.7	-9.2	Not reported

Physical functional scales: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	53

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-7.2	Not reported	-12.4	-1.9	Not reported

Physical functional scales: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	52

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-5.2	Not reported	-10.5	0.1	Not reported

Physical functional scales: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	47

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2.3	Not reported	-7.7	3.1	Not reported

Physical functional scales: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	49

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.8	Not reported	-10.2	0.5	Not reported

Physical functional scales: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	40

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0	Not reported	-5.6	5.7	Not reported

Physical functional scales: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	36

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-3.9	Not reported	-9.7	2	Not reported

Physical functional scales: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	40

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-0.6	Not reported	-6.3	5.1	Not reported

Physical functional scales: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.2	Not reported	-3.9	8.2	Not reported

Physical functional scales: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	1.5	Not reported	-4.5	7.5	Not reported

Physical functional scales: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	36

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.4	Not reported	-3.4	8.2	Not reported

Physical functional scales: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	3.1	Not reported	-2.9	9.1	Not reported

Physical functional scales: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	14

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	6.6	Not reported	-1.3	14.6	Not reported

Physical functional scales: Change at Day 352

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	7

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	6.4	Not reported	-4.1	16.9	Not reported

Physical functional scales: Change at Day 380

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-5.5	Not reported	-24.2	13.2	Not reported

Role functional scales: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	54

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-24.2	Not reported	-32.1	-16.3	Not reported

Role functional scales: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	53

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-12.3	Not reported	-20.3	-4.3	Not reported

Role functional scales: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	52

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-8.5	Not reported	-16.5	-0.4	Not reported

Role functional scales: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	47

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-3.5	Not reported	-11.8	4.8	Not reported

Role functional scales: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	49

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-3	Not reported	-11.2	5.2	Not reported

Role functional scales: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	40

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.3	Not reported	-8.3	9	Not reported

Role functional scales: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	36

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-3.7	Not reported	-12.7	5.2	Not reported

Role functional scales: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	40

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	1.1	Not reported	-7.6	9.7	Not reported

Role functional scales: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.3	Not reported	-8.9	9.6	Not reported

Role functional scales: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	1.3	Not reported	-7.9	10.5	Not reported

Role functional scales: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	37

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	5.5	Not reported	-3.4	14.3	Not reported

Role functional scales: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.2	Not reported	-5	13.3	Not reported

Role functional scales: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	14

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	7.3	Not reported	-5	19.6	Not reported

Role functional scales: Change at Day 352

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	7

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	8.3	Not reported	-8.1	24.6	Not reported

Role functional scales: Change at Day 380

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-3.5	Not reported	-33	25.9	Not reported

Emotional functional scales: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	51

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	3.1	Not reported	-1.1	7.4	Not reported

Emotional functional scales: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	51

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	6.1	Not reported	1.9	10.4	Not reported

Emotional functional scales: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	50

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	5.6	Not reported	1.3	9.9	Not reported

Emotional functional scales: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	45

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	5.7	Not reported	1.3	10.1	Not reported

Emotional functional scales: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	47

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.8	Not reported	0.5	9.2	Not reported

Emotional functional scales: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	38

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	6.3	Not reported	1.7	10.9	Not reported

Emotional functional scales: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	35

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	1.7	Not reported	-3	6.4	Not reported

Emotional functional scales: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	39

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	5.7	Not reported	1.1	10.3	Not reported

Emotional functional scales: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	6.3	Not reported	1.4	11.1	Not reported

Emotional functional scales: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	7.2	Not reported	2.4	12.1	Not reported

Emotional functional scales: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	37

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	5.9	Not reported	1.3	10.6	Not reported

Emotional functional scales: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	8.4	Not reported	3.5	13.2	Not reported

Emotional functional scales: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	14

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	12	Not reported	5.5	18.5	Not reported

Emotional functional scales: Change at Day 352

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	7

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	8.8	Not reported	0.1	17.4	Not reported

Emotional functional scales: Change at Day 380

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	16	Not reported	0.4	31.5	Not reported

Cognitive functional scales: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	51

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-0.4	Not reported	-4.8	4	Not reported

Cognitive functional scales: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	51

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	1.6	Not reported	-2.8	6	Not reported

Cognitive functional scales: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	50

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	1.2	Not reported	-3.3	5.6	Not reported

Cognitive functional scales: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	45

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.4	Not reported	-0.2	9.1	Not reported

Cognitive functional scales: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	47

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.3	Not reported	-2.3	6.8	Not reported

Cognitive functional scales: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	38

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	5	Not reported	0.1	9.9	Not reported

Cognitive functional scales: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	35

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.2	Not reported	-0.8	9.3	Not reported

Cognitive functional scales: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	39

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.1	Not reported	-0.7	9	Not reported

Cognitive functional scales: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	7.4	Not reported	2.2	12.5	Not reported

Cognitive functional scales: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	8.6	Not reported	3.4	13.8	Not reported

Cognitive functional scales: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	37

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	5.6	Not reported	0.7	10.6	Not reported

Cognitive functional scales: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	5.2	Not reported	0	10.4	Not reported

Cognitive functional scales: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	14

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	9.3	Not reported	2	16.6	Not reported

Cognitive functional scales: Change at Day 352

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	7

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.2	Not reported	-5.8	14.1	Not reported

Cognitive functional scales: Change at Day 380

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	22	Not reported	3.7	40.2	Not reported

Social functional scales: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	51

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-28.5	Not reported	-35.6	-21.5	Not reported

Social functional scales: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	51

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-13.8	Not reported	-20.9	-6.7	Not reported

Social functional scales: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	50

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-9.4	Not reported	-16.5	-2.2	Not reported

Social functional scales: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	45

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-3.8	Not reported	-11.2	3.6	Not reported

Social functional scales: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	47

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-3.5	Not reported	-10.8	3.8	Not reported

Social functional scales: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	38

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-1.2	Not reported	-9	6.6	Not reported

Social functional scales: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	35

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-1.5	Not reported	-9.5	6.5	Not reported

Social functional scales: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	39

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.4	Not reported	-7.4	8.1	Not reported

Social functional scales: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-1.3	Not reported	-9.4	6.9	Not reported

Social functional scales: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	1.1	Not reported	-7.1	9.4	Not reported

Social functional scales: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	37

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-0.5	Not reported	-8.3	7.4	Not reported

Social functional scales: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.2	Not reported	-5.9	10.4	Not reported

Social functional scales: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	14

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.5	Not reported	-10.7	11.6	Not reported

Social functional scales: Change at Day 352

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	7

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-0.1	Not reported	-15	14.9	Not reported

Social functional scales: Change at Day 380

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-0.5	Not reported	-27.7	26.6	Not reported

Global health status scale: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	50

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-9.7	Not reported	-15.1	-4.4	Not reported

Global health status scale: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	51

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-0.6	Not reported	-5.9	4.7	Not reported

Global health status scale: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	50

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	1.5	Not reported	-3.9	6.8	Not reported

Global health status scale: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	45

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.7	Not reported	-0.9	10.2	Not reported

Global health status scale: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	47

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.5	Not reported	-3	8	Not reported

Global health status scale: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	37

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	8.3	Not reported	2.3	14.3	Not reported

Global health status scale: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	35

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	8.4	Not reported	2.3	14.5	Not reported

Global health status scale: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	39

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	8.9	Not reported	3.1	14.8	Not reported

Global health status scale: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	7.7	Not reported	1.5	14	Not reported

Global health status scale: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	9.6	Not reported	3.3	16	Not reported

Global health status scale: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	37

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	7.8	Not reported	1.8	13.8	Not reported

Global health status scale: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	10.4	Not reported	4.2	16.7	Not reported

Global health status scale: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	14

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	11.5	Not reported	2.6	20.4	Not reported

Global health status scale: Change at Day 352

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	7

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	19.9	Not reported	7.8	32.1	Not reported

Global health status scale: Change at Day 380

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.4	Not reported	-17.9	26.8	Not reported

Pain symptom scales: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	54

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-1.9	Not reported	-8.5	4.6	Not reported

Pain symptom scales: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	53

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-9.9	Not reported	-16.5	-3.3	Not reported

Pain symptom scales: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	52

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-6.3	Not reported	-12.9	0.4	Not reported

Pain symptom scales: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	47

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-9.4	Not reported	-16.3	-2.5	Not reported

Pain symptom scales: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	50

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-10.5	Not reported	-17.3	-3.8	Not reported

Pain symptom scales: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	40

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-11.8	Not reported	-19.1	-4.6	Not reported

Pain symptom scales: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	36

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-13.1	Not reported	-20.6	-5.5	Not reported

Pain symptom scales: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	40

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-10	Not reported	-17.3	-2.7	Not reported

Pain symptom scales: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-11.7	Not reported	-19.5	-3.9	Not reported

Pain symptom scales: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-16.2	Not reported	-24.1	-8.3	Not reported

Pain symptom scales: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	37

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-16.7	Not reported	-24.2	-9.2	Not reported

Pain symptom scales: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-15.6	Not reported	-23.5	-7.8	Not reported

Pain symptom scales: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	14

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-14.9	Not reported	-25.9	-3.9	Not reported

Pain symptom scales: Change at Day 352

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	7

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-17.6	Not reported	-32.6	-2.6	Not reported

Pain symptom scales: Change at Day 380

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-0.7	Not reported	-28.2	26.7	Not reported

Fatigue symptom scales: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	54

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	14.3	Not reported	8.7	20	Not reported

Fatigue symptom scales: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	53

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	10.3	Not reported	4.6	16.1	Not reported

Fatigue symptom scales: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	52

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4	Not reported	-1.7	9.7	Not reported

Fatigue symptom scales: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	47

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-5.9	Not reported	-11.8	0	Not reported

Fatigue symptom scales: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	49

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0	Not reported	-5.9	5.8	Not reported

Fatigue symptom scales: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	40

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-7.7	Not reported	-13.9	-1.5	Not reported

Fatigue symptom scales: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	36

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-5.1	Not reported	-11.5	1.2	Not reported

Fatigue symptom scales: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	40

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-8.1	Not reported	-14.3	-1.9	Not reported

Fatigue symptom scales: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-11.5	Not reported	-18.1	-4.8	Not reported

Fatigue symptom scales: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-12.6	Not reported	-19.2	-5.9	Not reported

Fatigue symptom scales: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	37

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-13.4	Not reported	-19.8	-7.1	Not reported

Fatigue symptom scales: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-14.2	Not reported	-20.8	-7.6	Not reported

Fatigue symptom scales: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	14

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-14.6	Not reported	-23.6	-5.6	Not reported

Fatigue symptom scales: Change at Day 352

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	7

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-15.7	Not reported	-27.7	-3.7	Not reported

Fatigue symptom scales: Change at Day 380

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-5.6	Not reported	-27.3	16.1	Not reported

Nausea/vomiting symptom scales: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	54

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	13.3	Not reported	9.8	16.9	Not reported

Nausea/vomiting symptom scales: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	53

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	1.7	Not reported	-1.9	5.3	Not reported

Nausea/vomiting symptom scales: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	52

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.2	Not reported	-1.5	5.8	Not reported

Nausea/vomiting symptom scales: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	47

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-0.2	Not reported	-4	3.6	Not reported

Nausea/vomiting symptom scales: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	49

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-0.2	Not reported	-4	3.5	Not reported

Nausea/vomiting symptom scales: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	40

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2.6	Not reported	-6.6	1.5	Not reported

Nausea/vomiting symptom scales: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	36

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2.6	Not reported	-6.9	1.6	Not reported

Nausea/vomiting symptom scales: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	40

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-0.2	Not reported	-4.2	3.9	Not reported

Nausea/vomiting symptom scales: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-1	Not reported	-5.5	3.5	Not reported

Nausea/vomiting symptom scales: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-3.4	Not reported	-7.9	1	Not reported

Nausea/vomiting symptom scales: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	37

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2.5	Not reported	-6.7	1.7	Not reported

Nausea/vomiting symptom scales: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-3.5	Not reported	-7.9	1	Not reported

Nausea/vomiting symptom scales: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	14

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2.9	Not reported	-9.4	3.6	Not reported

Nausea/vomiting symptom scales: Change at Day 352

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	7

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.4	Not reported	-13.4	4.6	Not reported

Nausea/vomiting symptom scales: Change at Day 380

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.5	Not reported	-12.3	21.2	Not reported

Dyspnea: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	54

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.6	Not reported	-2.7	8	Not reported

Dyspnea: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	53

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	4.6	Not reported	-0.8	10	Not reported

Dyspnea: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	52

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	1.3	Not reported	-4.1	6.8	Not reported

Dyspnea: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	47

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-1.9	Not reported	-7.6	3.8	Not reported

Dyspnea: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	48

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-3	Not reported	-8.7	2.6	Not reported

Dyspnea: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	39

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-1.5	Not reported	-7.6	4.6	Not reported

Dyspnea: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	36

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-1.3	Not reported	-7.6	5	Not reported

Dyspnea: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	40

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2.9	Not reported	-8.9	3.2	Not reported

Dyspnea: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-7	Not reported	-13.6	-0.4	Not reported

Dyspnea: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.1	Not reported	-10.7	2.5	Not reported

Dyspnea: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	37

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-8.7	Not reported	-15	-2.5	Not reported

Dyspnea: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-10.9	Not reported	-17.5	-4.4	Not reported

Dyspnea: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	14

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-7.6	Not reported	-17	1.8	Not reported

Dyspnea: Change at Day 352

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	7

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-6.5	Not reported	-19.4	6.4	Not reported

Dyspnea: Change at Day 380

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-22.5	Not reported	-46.3	1.4	Not reported

Insomnia: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	54

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	9.4	Not reported	2.9	15.9	Not reported

Insomnia: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	52

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.6	Not reported	-11.2	2	Not reported

Insomnia: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	52

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-1.4	Not reported	-8	5.3	Not reported

Insomnia: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	47

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2.6	Not reported	-9.5	4.3	Not reported

Insomnia: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	49

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-3.1	Not reported	-9.9	3.6	Not reported

Insomnia: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	40

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-7.1	Not reported	-14.4	0.2	Not reported

Insomnia: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	36

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-7.1	Not reported	-14.7	0.5	Not reported

Insomnia: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	40

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2.3	Not reported	-9.6	5	Not reported

Insomnia: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.4	Not reported	-12.4	3.5	Not reported

Insomnia: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-6.3	Not reported	-14.2	1.7	Not reported

Insomnia: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	37

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-6.7	Not reported	-14.3	0.8	Not reported

Insomnia: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.9	Not reported	-12.8	3	Not reported

Insomnia: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	14

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-1.6	Not reported	-12.9	9.6	Not reported

Insomnia: Change at Day 352

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	7

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	1	Not reported	-14.4	16.5	Not reported

Insomnia: Change at Day 380

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-18.3	Not reported	-46.7	10.1	Not reported

Appetite loss: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	54

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	22.2	Not reported	16	28.4	Not reported

Appetite loss: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	53

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	8.4	Not reported	2.1	14.6	Not reported

Appetite loss: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	52

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	2.5	Not reported	-3.8	8.8	Not reported

Appetite loss: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	47

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-0.7	Not reported	-7.3	5.8	Not reported

Appetite loss: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	49

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	3	Not reported	-3.5	9.4	Not reported

Appetite loss: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	40

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.3	Not reported	-11.3	2.7	Not reported

Appetite loss: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	36

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-5	Not reported	-12.3	2.3	Not reported

Appetite loss: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	40

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.7	Not reported	-11.7	2.2	Not reported

Appetite loss: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-7.9	Not reported	-15.5	-0.3	Not reported

Appetite loss: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-10.5	Not reported	-18.1	-2.9	Not reported

Appetite loss: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	37

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-12.4	Not reported	-19.6	-5.2	Not reported

Appetite loss: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-11	Not reported	-18.5	-3.4	Not reported

Appetite loss: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	14

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-9.5	Not reported	-20.4	1.3	Not reported

Appetite loss: Change at Day 352

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	7

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-9.8	Not reported	-24.8	5.2	Not reported

Appetite loss: Change at Day 380

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-6.1	Not reported	-33.7	21.5	Not reported

Constipation: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	54

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	12.7	Not reported	8.4	17	Not reported

Constipation: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	53

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-0.1	Not reported	-4.5	4.2	Not reported

Constipation: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	52

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2	Not reported	-6.4	2.4	Not reported

Constipation: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	47

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-6.3	Not reported	-10.9	-1.7	Not reported

Constipation: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	49

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-7	Not reported	-11.5	-2.5	Not reported

Constipation: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	40

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.5	Not reported	-9.4	0.5	Not reported

Constipation: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	36

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-6.3	Not reported	-11.5	-1.2	Not reported

Constipation: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	40

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-8.1	Not reported	-13	-3.2	Not reported

Constipation: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.4	Not reported	-9.8	1.1	Not reported

Constipation: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-10.1	Not reported	-15.5	-4.6	Not reported

Constipation: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	37

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-6.6	Not reported	-11.7	-1.5	Not reported

Constipation: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-7.1	Not reported	-12.4	-1.7	Not reported

Constipation: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	14

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-9.3	Not reported	-17.2	-1.4	Not reported

Constipation: Change at Day 352

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	7

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-12.3	Not reported	-23.3	-1.3	Not reported

Constipation: Change at Day 380

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-16.5	Not reported	-36	36.9	Not reported

Diarrhea: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	51

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	1.7	Not reported	-3.6	6.9	Not reported

Diarrhea: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	50

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-3.1	Not reported	-8.4	2.2	Not reported

Diarrhea: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	50

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	1.2	Not reported	-4.1	6.5	Not reported

Diarrhea: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	45

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	5	Not reported	-0.5	10.6	Not reported

Diarrhea: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	47

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	0.1	Not reported	-5.3	5.5	Not reported

Diarrhea: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	38

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-1.6	Not reported	-7.5	4.3	Not reported

Diarrhea: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	35

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	1.1	Not reported	-5	7.2	Not reported

Diarrhea: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	39

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.5	Not reported	-10.3	1.4	Not reported

Diarrhea: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-6.8	Not reported	-13.1	-0.6	Not reported

Diarrhea: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2.6	Not reported	-9	3.7	Not reported

Diarrhea: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	37

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-5.4	Not reported	-11.3	0.6	Not reported

Diarrhea: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-8.2	Not reported	-14.5	-2	Not reported

Diarrhea: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	14

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-12.2	Not reported	-21.3	-3	Not reported

Diarrhea: Change at Day 352

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	7

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-11.9	Not reported	-24.5	0.7	Not reported

Diarrhea: Change at Day 380

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-26.2	Not reported	-49.5	-2.9	Not reported

Financial difficulties: Change at Day 7

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	50

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	3.8	Not reported	-2.5	10	Not reported

Financial difficulties: Change at Day 28

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	51

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2.7	Not reported	-8.9	3.6	Not reported

Financial difficulties: Change at Day 56

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	49

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-1.4	Not reported	-7.7	4.9	Not reported

Financial difficulties: Change at Day 78

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	45

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.5	Not reported	-10.9	2	Not reported

Financial difficulties: Change at Day 100

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	47

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.3	Not reported	-10.7	2.1	Not reported

Financial difficulties: Change at Day 128

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	38

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-6.4	Not reported	-13.3	0.4	Not reported

Financial difficulties: Change at Day 156

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	35

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.7	Not reported	-11.7	2.3	Not reported

Financial difficulties: Change at Day 184

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	39

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-5.2	Not reported	-11.9	1.6	Not reported

Financial difficulties: Change at Day 212

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-2.7	Not reported	-9.8	4.4	Not reported

Financial difficulties: Change at Day 240

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	32

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-4.1	Not reported	-11.3	3.1	Not reported

Financial difficulties: Change at Day 268

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	37

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-9.1	Not reported	-15.9	-2.2	Not reported

Financial difficulties: Change at Day 296

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	33

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-8.3	Not reported	-15.5	-1.2	Not reported

Financial difficulties: Change at Day 324

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	14

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-12	Not reported	-21.7	-2.3	Not reported

Financial difficulties: Change at Day 352

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	7

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-12.8	Not reported	-25.8	0.2	Not reported

Financial difficulties: Change at Day 380

Analysis denominator · Participants

Group	Source count
Phase 2 (US Population)	2

Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (US Population)	-21.2	Not reported	-44.6	2.3	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
-19.7
upper Limit
-9.2
value
-14.4
denoms
counts
group Id
OG000
value
54
units
Participants
title
Physical functional scales: Change at Day 7
categories
measurements
group Id
OG000
lower Limit
-12.4
upper Limit
-1.9
value
-7.2
denoms
counts
group Id
OG000
value
53
units
Participants
title
Physical functional scales: Change at Day 28
categories
measurements
group Id
OG000
lower Limit
-10.5
upper Limit
0.1
value
-5.2
denoms
counts
group Id
OG000
value
52
units
Participants
title
Physical functional scales: Change at Day 56
categories
measurements
group Id
OG000
lower Limit
-7.7
upper Limit
3.1
value
-2.3
denoms
counts
group Id
OG000
value
47
units
Participants
title
Physical functional scales: Change at Day 78
categories
measurements
group Id
OG000
lower Limit
-10.2
upper Limit
0.5
value
-4.8
denoms
counts
group Id
OG000
value
49
units
Participants
title
Physical functional scales: Change at Day 100
categories
measurements
group Id
OG000
lower Limit
-5.6
upper Limit
5.7
value
0
denoms
counts
group Id
OG000
value
40
units
Participants
title
Physical functional scales: Change at Day 128
categories
measurements
group Id
OG000
lower Limit
-9.7
upper Limit
2
value
-3.9
denoms
counts
group Id
OG000
value
36
units
Participants
title
Physical functional scales: Change at Day 156
categories
measurements
group Id
OG000
lower Limit
-6.3
upper Limit
5.1
value
-0.6
denoms
counts
group Id
OG000
value
40
units
Participants
title
Physical functional scales: Change at Day 184
categories
measurements
group Id
OG000
lower Limit
-3.9
upper Limit
8.2
value
2.2
denoms
counts
group Id
OG000
value
32
units
Participants
title
Physical functional scales: Change at Day 212
categories
measurements
group Id
OG000
lower Limit
-4.5
upper Limit
7.5
value
1.5
denoms
counts
group Id
OG000
value
32
units
Participants
title
Physical functional scales: Change at Day 240
categories
measurements
group Id
OG000
lower Limit
-3.4
upper Limit
8.2
value
2.4
denoms
counts
group Id
OG000
value
36
units
Participants
title
Physical functional scales: Change at Day 268
categories
measurements
group Id
OG000
lower Limit
-2.9
upper Limit
9.1
value
3.1
denoms
counts
group Id
OG000
value
33
units
Participants
title
Physical functional scales: Change at Day 296

denoms

counts
group Id
OG000
value
54
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

95% Confidence Interval

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

LEAST_SQUARES_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, 324, 352 and 380

title

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

type

SECONDARY

unit Of Measure

Score on a scale

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

Preserved source evidence · Not medical advice