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NCT02094573 · OUTCOME

Patient-reported Symptoms Global Health Status/Quality of Life (QoL) Scores

A Study to Evaluate the Efficacy of Brigatinib (AP26113) in Participants With Anaplastic Lymphoma Kinase (ALK)-Positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib · Source last updated 2021-03-15

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

Measure: MEAN
Unit: unit on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline and at each 28-day cycle up to end of the study (up to approximately 69 months)

What was measured

Patient-reported symptoms global health status/quality of life (QoL) scores were based on questions 29 and 30 of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ-C30). The first 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and last 2 questions on global health status/QoL scale are coded on 7-point scale (1=very poor to 7=excellent). Six single-item scales also are included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Raw scores for multi-item scales and single-item measures was linearly transformed to obtain the score ranging from 0 to 100, where higher score represents a higher ("better") level of functioning.

Analysis population: ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.

Groups in this outcome

Brigatinib 90 mg

Brigatinib 90 mg, tablets, orally, once daily in each Cycle of 28 days until disease progression or intolerable toxicity (median duration of exposure was 402 days).

Brigatinib 90 mg - 180 mg

Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in Cycle 2 and onward Cycles of 28 days until disease progression or intolerable toxicity (median duration of exposure was 522 days).

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
Brigatinib 90 mg	112
Brigatinib 90 mg - 180 mg	110

Reported measurements

Baseline

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	108
Brigatinib 90 mg - 180 mg	108

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	52.39	27.42	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	58.49	23.40	Not reported	Not reported	Not reported

Cycle 2

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	101
Brigatinib 90 mg - 180 mg	97

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	64.19	20.73	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	65.72	19.54	Not reported	Not reported	Not reported

Cycle 3

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	91
Brigatinib 90 mg - 180 mg	91

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	65.57	24.06	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	68.50	20.52	Not reported	Not reported	Not reported

Cycle 4

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	84
Brigatinib 90 mg - 180 mg	89

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	69.44	20.59	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	66.95	20.89	Not reported	Not reported	Not reported

Cycle 5

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	82
Brigatinib 90 mg - 180 mg	85

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	70.12	20.28	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	71.86	17.63	Not reported	Not reported	Not reported

Cycle 6

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	79
Brigatinib 90 mg - 180 mg	82

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	70.15	20.18	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	71.24	18.66	Not reported	Not reported	Not reported

Cycle 7

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	77
Brigatinib 90 mg - 180 mg	80

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	67.42	20.29	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	70.21	21.66	Not reported	Not reported	Not reported

Cycle 8

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	73
Brigatinib 90 mg - 180 mg	78

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	67.24	22.79	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	69.87	20.42	Not reported	Not reported	Not reported

Cycle 9

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	70
Brigatinib 90 mg - 180 mg	75

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	68.45	22.61	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	68.67	21.35	Not reported	Not reported	Not reported

Cycle 10

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	65
Brigatinib 90 mg - 180 mg	70

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	71.79	20.61	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	67.98	23.25	Not reported	Not reported	Not reported

Cycle 11

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	61
Brigatinib 90 mg - 180 mg	70

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	72.54	19.56	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	68.45	21.37	Not reported	Not reported	Not reported

Cycle 12

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	61
Brigatinib 90 mg - 180 mg	65

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	68.03	23.08	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	70.51	21.35	Not reported	Not reported	Not reported

Cycle 13

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	58
Brigatinib 90 mg - 180 mg	64

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	70.11	19.93	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	72.79	19.20	Not reported	Not reported	Not reported

Cycle 14

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	55
Brigatinib 90 mg - 180 mg	57

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	69.55	20.04	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	70.76	19.42	Not reported	Not reported	Not reported

Cycle 15

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	54
Brigatinib 90 mg - 180 mg	58

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	70.06	21.08	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	70.83	20.66	Not reported	Not reported	Not reported

Cycle 16

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	50
Brigatinib 90 mg - 180 mg	58

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	68.17	22.94	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	72.27	18.36	Not reported	Not reported	Not reported

Cycle 17

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	48
Brigatinib 90 mg - 180 mg	61

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	73.61	18.78	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	69.81	20.36	Not reported	Not reported	Not reported

Cycle 18

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	43
Brigatinib 90 mg - 180 mg	58

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	67.64	22.80	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	71.55	17.94	Not reported	Not reported	Not reported

Cycle 19

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	43
Brigatinib 90 mg - 180 mg	55

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	69.57	23.14	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	72.12	20.49	Not reported	Not reported	Not reported

Cycle 20

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	40
Brigatinib 90 mg - 180 mg	52

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	66.04	24.05	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	72.76	18.53	Not reported	Not reported	Not reported

Cycle 21

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	39
Brigatinib 90 mg - 180 mg	50

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	69.23	22.87	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	69.83	19.04	Not reported	Not reported	Not reported

Cycle 22

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	36
Brigatinib 90 mg - 180 mg	46

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	72.69	21.70	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	71.20	18.90	Not reported	Not reported	Not reported

Cycle 23

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	35
Brigatinib 90 mg - 180 mg	47

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	72.38	21.93	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	71.10	20.10	Not reported	Not reported	Not reported

Cycle 24

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	32
Brigatinib 90 mg - 180 mg	42

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	72.66	19.66	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	71.43	15.74	Not reported	Not reported	Not reported

Cycle 25

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	34
Brigatinib 90 mg - 180 mg	39

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	71.57	21.72	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	70.09	19.38	Not reported	Not reported	Not reported

Cycle 26

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	32
Brigatinib 90 mg - 180 mg	36

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	71.88	22.28	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	69.68	20.43	Not reported	Not reported	Not reported

Cycle 27

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	33
Brigatinib 90 mg - 180 mg	36

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	71.46	20.94	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	70.83	21.96	Not reported	Not reported	Not reported

Cycle 28

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	31
Brigatinib 90 mg - 180 mg	37

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	71.24	22.24	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	69.59	20.24	Not reported	Not reported	Not reported

Cycle 29

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	30
Brigatinib 90 mg - 180 mg	37

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	70.00	21.73	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	71.17	22.27	Not reported	Not reported	Not reported

Cycle 30

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	29
Brigatinib 90 mg - 180 mg	34

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	69.25	21.72	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	70.83	18.03	Not reported	Not reported	Not reported

Cycle 31

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	26
Brigatinib 90 mg - 180 mg	33

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	75.64	17.63	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	69.95	18.15	Not reported	Not reported	Not reported

Cycle 32

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	25
Brigatinib 90 mg - 180 mg	31

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	73.00	20.02	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	70.97	20.28	Not reported	Not reported	Not reported

Cycle 33

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	25
Brigatinib 90 mg - 180 mg	32

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	71.67	20.41	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	70.31	20.84	Not reported	Not reported	Not reported

Cycle 34

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	21
Brigatinib 90 mg - 180 mg	31

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	72.62	20.61	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	69.62	20.70	Not reported	Not reported	Not reported

Cycle 35

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	21
Brigatinib 90 mg - 180 mg	31

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	72.22	18.88	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	66.67	22.97	Not reported	Not reported	Not reported

Cycle 36

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	20
Brigatinib 90 mg - 180 mg	30

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	68.33	22.72	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	71.67	19.89	Not reported	Not reported	Not reported

Cycle 37

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	20
Brigatinib 90 mg - 180 mg	30

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	73.33	19.42	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	72.50	19.47	Not reported	Not reported	Not reported

Cycle 38

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	18
Brigatinib 90 mg - 180 mg	29

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	68.98	22.10	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	72.99	17.49	Not reported	Not reported	Not reported

Cycle 39

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	17
Brigatinib 90 mg - 180 mg	26

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	68.63	25.09	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	73.72	19.96	Not reported	Not reported	Not reported

Cycle 40

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	17
Brigatinib 90 mg - 180 mg	26

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	71.57	24.13	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	69.87	23.10	Not reported	Not reported	Not reported

Cycle 41

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	17
Brigatinib 90 mg - 180 mg	26

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	72.55	21.20	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	68.27	22.98	Not reported	Not reported	Not reported

Cycle 42

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	17
Brigatinib 90 mg - 180 mg	24

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	72.06	21.84	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	72.57	20.78	Not reported	Not reported	Not reported

Cycle 43

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	17
Brigatinib 90 mg - 180 mg	23

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	67.65	24.63	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	71.01	22.17	Not reported	Not reported	Not reported

Cycle 44

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	17
Brigatinib 90 mg - 180 mg	22

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	72.55	20.57	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	73.48	19.35	Not reported	Not reported	Not reported

Cycle 45

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	14
Brigatinib 90 mg - 180 mg	22

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	66.67	19.88	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	72.35	22.03	Not reported	Not reported	Not reported

Cycle 46

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	15
Brigatinib 90 mg - 180 mg	22

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	70.56	19.12	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	71.59	20.52	Not reported	Not reported	Not reported

Cycle 47

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	14
Brigatinib 90 mg - 180 mg	21

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	60.12	25.36	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	73.02	19.88	Not reported	Not reported	Not reported

Cycle 48

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	13
Brigatinib 90 mg - 180 mg	21

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	65.38	20.93	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	74.60	19.80	Not reported	Not reported	Not reported

Cycle 49

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	13
Brigatinib 90 mg - 180 mg	20

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	57.69	24.88	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	71.67	22.69	Not reported	Not reported	Not reported

Cycle 50

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	13
Brigatinib 90 mg - 180 mg	20

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	61.54	26.47	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	70.00	24.54	Not reported	Not reported	Not reported

Cycle 51

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	12
Brigatinib 90 mg - 180 mg	21

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	63.19	23.96	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	69.05	22.69	Not reported	Not reported	Not reported

Cycle 52

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	12
Brigatinib 90 mg - 180 mg	21

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	56.94	22.71	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	72.22	22.26	Not reported	Not reported	Not reported

Cycle 53

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	12
Brigatinib 90 mg - 180 mg	20

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	61.11	21.42	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	70.83	23.02	Not reported	Not reported	Not reported

Cycle 54

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	12
Brigatinib 90 mg - 180 mg	19

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	61.81	25.24	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	71.49	20.47	Not reported	Not reported	Not reported

Cycle 55

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	10
Brigatinib 90 mg - 180 mg	19

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	63.33	26.12	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	72.37	20.42	Not reported	Not reported	Not reported

Cycle 56

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	9
Brigatinib 90 mg - 180 mg	18

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	63.89	23.94	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	73.61	19.23	Not reported	Not reported	Not reported

Cycle 57

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	10
Brigatinib 90 mg - 180 mg	17

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	65.00	19.95	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	73.53	19.37	Not reported	Not reported	Not reported

Cycle 58

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	10
Brigatinib 90 mg - 180 mg	14

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	65.00	25.09	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	70.83	20.61	Not reported	Not reported	Not reported

Cycle 59

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	9
Brigatinib 90 mg - 180 mg	14

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	64.81	25.27	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	71.43	19.81	Not reported	Not reported	Not reported

Cycle 60

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	8
Brigatinib 90 mg - 180 mg	9

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	70.83	27.82	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	73.15	19.44	Not reported	Not reported	Not reported

Cycle 61

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	7
Brigatinib 90 mg - 180 mg	8

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	71.43	28.41	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	78.13	19.89	Not reported	Not reported	Not reported

Cycle 62

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	5
Brigatinib 90 mg - 180 mg	7

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	66.67	23.57	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	79.76	15.85	Not reported	Not reported	Not reported

Cycle 63

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	4
Brigatinib 90 mg - 180 mg	7

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	58.33	31.91	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	78.57	17.91	Not reported	Not reported	Not reported

Cycle 64

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	3
Brigatinib 90 mg - 180 mg	7

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	61.11	34.69	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	77.38	20.81	Not reported	Not reported	Not reported

Cycle 65

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	2
Brigatinib 90 mg - 180 mg	6

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	75.00	35.36	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	76.39	22.62	Not reported	Not reported	Not reported

Cycle 66

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	2
Brigatinib 90 mg - 180 mg	4

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	75.00	35.36	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	77.08	31.46	Not reported	Not reported	Not reported

Cycle 67

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	2
Brigatinib 90 mg - 180 mg	1

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	75.00	35.36	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	41.67	NA	Not reported	Not reported	Standard deviation (SD) was not evaluable for 1 participant.

Cycle 68

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	0
Brigatinib 90 mg - 180 mg	1

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg - 180 mg	41.67	NA	Not reported	Not reported	SD was not evaluable for 1 participant.

Cycle 69

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	0
Brigatinib 90 mg - 180 mg	1

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg - 180 mg	58.33	NA	Not reported	Not reported	SD was not evaluable for 1 participant.

Cycle 70

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	0
Brigatinib 90 mg - 180 mg	1

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg - 180 mg	41.67	NA	Not reported	Not reported	SD was not evaluable for 1 participant.

Cycle 71

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	0
Brigatinib 90 mg - 180 mg	1

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg - 180 mg	41.67	NA	Not reported	Not reported	SD was not evaluable for 1 participant.

Cycle 72

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	0
Brigatinib 90 mg - 180 mg	1

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg - 180 mg	75.00	NA	Not reported	Not reported	SD was not evaluable for 1 participant.

End of Treatment

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	80
Brigatinib 90 mg - 180 mg	68

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	52.29	28.25	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	61.15	23.15	Not reported	Not reported	Not reported

Follow-Up 30 Days After Last Dose

Analysis denominator · Participants

Group	Source count
Brigatinib 90 mg	43
Brigatinib 90 mg - 180 mg	45

Values in unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Brigatinib 90 mg	61.05	30.58	Not reported	Not reported	Not reported
Brigatinib 90 mg - 180 mg	61.67	23.33	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
27.42
value
52.39
group Id
OG001
spread
23.40
value
58.49
denoms
counts
group Id
OG000
value
108
group Id
OG001
value
108
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
20.73
value
64.19
group Id
OG001
spread
19.54
value
65.72
denoms
counts
group Id
OG000
value
101
group Id
OG001
value
97
units
Participants
title
Cycle 2
categories
measurements
group Id
OG000
spread
24.06
value
65.57
group Id
OG001
spread
20.52
value
68.50
denoms
counts
group Id
OG000
value
91
group Id
OG001
value
91
units
Participants
title
Cycle 3
categories
measurements
group Id
OG000
spread
20.59
value
69.44
group Id
OG001
spread
20.89
value
66.95
denoms
counts
group Id
OG000
value
84
group Id
OG001
value
89
units
Participants
title
Cycle 4
categories
measurements
group Id
OG000
spread
20.28
value
70.12
group Id
OG001
spread
17.63
value
71.86
denoms
counts
group Id
OG000
value
82
group Id
OG001
value
85
units
Participants
title
Cycle 5
categories
measurements
group Id
OG000
spread
20.18
value
70.15
group Id
OG001
spread
18.66
value
71.24
denoms
counts
group Id
OG000
value
79
group Id
OG001
value
82
units
Participants
title
Cycle 6
categories
measurements
group Id
OG000
spread
20.29
value
67.42
group Id
OG001
spread
21.66
value
70.21
denoms
counts
group Id
OG000
value
77
group Id
OG001
value
80
units
Participants
title
Cycle 7
categories
measurements
group Id
OG000
spread
22.79
value
67.24
group Id
OG001
spread
20.42
value
69.87
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
78
units
Participants
title
Cycle 8
categories
measurements
group Id
OG000
spread
22.61
value
68.45
group Id
OG001
spread
21.35
value
68.67
denoms
counts
group Id
OG000
value
70
group Id
OG001
value
75
units
Participants
title
Cycle 9
categories
measurements
group Id
OG000
spread
20.61
value
71.79
group Id
OG001
spread
23.25
value
67.98
denoms
counts
group Id
OG000
value
65
group Id
OG001
value
70
units
Participants
title
Cycle 10
categories
measurements
group Id
OG000
spread
19.56
value
72.54
group Id
OG001
spread
21.37
value
68.45
denoms
counts
group Id
OG000
value
61
group Id
OG001
value
70
units
Participants
title
Cycle 11
categories
measurements
group Id
OG000
spread
23.08
value
68.03
group Id
OG001
spread
21.35
value
70.51
denoms
counts
group Id
OG000
value
61
group Id
OG001
value
65
units
Participants
title
Cycle 12

denoms

counts
group Id
OG000
value
112
group Id
OG001
value
110
units
Participants

description

Patient-reported symptoms global health status/quality of life (QoL) scores were based on questions 29 and 30 of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ-C30). The first 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and last 2 questions on global health status/QoL scale are coded on 7-point scale (1=very poor to 7=excellent). Six single-item scales also are included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Raw scores for multi-item scales and single-item measures was linearly transformed to obtain the score ranging from 0 to 100, where higher score represents a higher ("better") level of functioning.

dispersion Type

Standard Deviation

groups

description
Brigatinib 90 mg, tablets, orally, once daily in each Cycle of 28 days until disease progression or intolerable toxicity (median duration of exposure was 402 days).
id
OG000
title
Brigatinib 90 mg
description
Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in Cycle 2 and onward Cycles of 28 days until disease progression or intolerable toxicity (median duration of exposure was 522 days).
id
OG001
title
Brigatinib 90 mg - 180 mg

param Type

MEAN

population Description

ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.

reporting Status

POSTED

time Frame

Baseline and at each 28-day cycle up to end of the study (up to approximately 69 months)

title

Patient-reported Symptoms Global Health Status/Quality of Life (QoL) Scores

type

SECONDARY

unit Of Measure

unit on a scale

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

Preserved source evidence · Not medical advice