NCT02008227 · OUTCOME

EORTC QLQ-LC13 Questionnaire Score: Sore Mouth

A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy · Source last updated 2019-12-20

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

Measure: MEAN
Unit: Units on a scale
Interval / dispersion: Standard Deviation
Time frame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

What was measured

QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for sore mouth.

Analysis population: The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Groups in this outcome

Docetaxel

Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.

Atezolizumab

Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.

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
Docetaxel	425
Atezolizumab	425

Reported measurements

Sore Mouth: Baseline (n= 387, 404)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	5.68	16.34	Not reported	Not reported	Not reported
Atezolizumab	4.95	15.32	Not reported	Not reported	Not reported

Sore Mouth: C2D1(n= 335, 357)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	15.52	25.75	Not reported	Not reported	Not reported
Atezolizumab	7.10	18.17	Not reported	Not reported	Not reported

Sore Mouth: C3D1(n= 252, 297)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	14.29	23.59	Not reported	Not reported	Not reported
Atezolizumab	5.61	14.18	Not reported	Not reported	Not reported

Sore Mouth: C4D1(n= 219, 270)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	14.00	22.95	Not reported	Not reported	Not reported
Atezolizumab	4.81	13.99	Not reported	Not reported	Not reported

Sore Mouth: C5D1(n= 165, 234)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	11.31	19.65	Not reported	Not reported	Not reported
Atezolizumab	4.27	13.49	Not reported	Not reported	Not reported

Sore Mouth: C6D1(n= 148, 218)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	13.29	23.24	Not reported	Not reported	Not reported
Atezolizumab	4.13	13.89	Not reported	Not reported	Not reported

Sore Mouth: C7D1(n= 87, 185)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	9.20	20.77	Not reported	Not reported	Not reported
Atezolizumab	5.59	15.50	Not reported	Not reported	Not reported

Sore Mouth: C8D1(n=70, 166)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	8.57	16.73	Not reported	Not reported	Not reported
Atezolizumab	5.02	14.96	Not reported	Not reported	Not reported

Sore Mouth: C9D1(n= 50, 151)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	6.00	17.42	Not reported	Not reported	Not reported
Atezolizumab	3.09	14.06	Not reported	Not reported	Not reported

Sore Mouth: C10D1(n= 47, 143)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	7.09	15.44	Not reported	Not reported	Not reported
Atezolizumab	3.96	14.53	Not reported	Not reported	Not reported

Sore Mouth: C11D1(n= 37, 130)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	4.50	13.97	Not reported	Not reported	Not reported
Atezolizumab	3.33	12.35	Not reported	Not reported	Not reported

Sore Mouth: C12D1(n= 30, 129)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	2.22	8.46	Not reported	Not reported	Not reported
Atezolizumab	4.65	14.87	Not reported	Not reported	Not reported

Sore Mouth: C13D1(n= 19, 121)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	1.75	7.65	Not reported	Not reported	Not reported
Atezolizumab	5.23	15.52	Not reported	Not reported	Not reported

Sore Mouth: C14D1(n= 18, 119)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	3.70	10.78	Not reported	Not reported	Not reported
Atezolizumab	5.32	15.64	Not reported	Not reported	Not reported

Sore Mouth: C15D1(n= 15, 110)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	0.00	0.00	Not reported	Not reported	Not reported
Atezolizumab	4.24	13.63	Not reported	Not reported	Not reported

Sore Mouth: C16D1(n= 13, 106)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	0.00	0.00	Not reported	Not reported	Not reported
Atezolizumab	3.77	16.15	Not reported	Not reported	Not reported

Sore Mouth: C17D1(n= 11, 95)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	3.03	10.05	Not reported	Not reported	Not reported
Atezolizumab	6.32	17.73	Not reported	Not reported	Not reported

Sore Mouth: C18D1(n= 10, 90)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	3.33	10.54	Not reported	Not reported	Not reported
Atezolizumab	3.70	11.66	Not reported	Not reported	Not reported

Sore Mouth: C19D1(n= 9, 82)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	0.00	0.00	Not reported	Not reported	Not reported
Atezolizumab	4.47	12.57	Not reported	Not reported	Not reported

Sore Mouth: C20D1(n= 9, 78)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	0.00	0.00	Not reported	Not reported	Not reported
Atezolizumab	5.56	15.59	Not reported	Not reported	Not reported

Sore Mouth: C21D1(n= 9, 73)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	0.00	0.00	Not reported	Not reported	Not reported
Atezolizumab	7.76	17.14	Not reported	Not reported	Not reported

Sore Mouth: C22D1(n= 8, 67)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	4.17	11.78	Not reported	Not reported	Not reported
Atezolizumab	6.47	17.64	Not reported	Not reported	Not reported

Sore Mouth: C23D1(n= 8, 64)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	4.17	11.78	Not reported	Not reported	Not reported
Atezolizumab	6.25	16.67	Not reported	Not reported	Not reported

Sore Mouth: C24D1(n= 5, 62)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	0.00	0.00	Not reported	Not reported	Not reported
Atezolizumab	5.38	13.75	Not reported	Not reported	Not reported

Sore Mouth: C25D1(n= 3, 57)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	0.00	0.00	Not reported	Not reported	Not reported
Atezolizumab	3.51	10.32	Not reported	Not reported	Not reported

Sore Mouth: C26D1(n= 3, 53)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	0.00	0.00	Not reported	Not reported	Not reported
Atezolizumab	6.92	13.65	Not reported	Not reported	Not reported

Sore Mouth: C27D1(n= 3, 50)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	0.00	0.00	Not reported	Not reported	Not reported
Atezolizumab	4.00	10.94	Not reported	Not reported	Not reported

Sore Mouth: C28D1(n= 2, 46)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	0.00	0.00	Not reported	Not reported	Not reported
Atezolizumab	4.35	11.35	Not reported	Not reported	Not reported

Sore Mouth: C29D1(n= 2, 38)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	0.00	0.00	Not reported	Not reported	Not reported
Atezolizumab	3.51	10.37	Not reported	Not reported	Not reported

Sore Mouth: C30D1(n= 1, 31)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	0.00	NA	Not reported	Not reported	Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
Atezolizumab	4.30	11.36	Not reported	Not reported	Not reported

Sore Mouth: C31D1(n= 0, 24)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	NA	NA	Not reported	Not reported	Data not reported because no participant was evaluated for this category
Atezolizumab	4.17	11.26	Not reported	Not reported	Not reported

Sore Mouth: C32D1(n= 0, 23)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	NA	NA	Not reported	Not reported	Data not reported because no participant was evaluated for this category
Atezolizumab	4.35	11.48	Not reported	Not reported	Not reported

Sore Mouth: C33D1(n= 0, 16)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	NA	NA	Not reported	Not reported	Data not reported because no participant was evaluated for this category
Atezolizumab	4.17	11.39	Not reported	Not reported	Not reported

Sore Mouth: C34D1(n= 0, 14)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	NA	NA	Not reported	Not reported	Data not reported because no participant was evaluated for this category
Atezolizumab	9.52	15.63	Not reported	Not reported	Not reported

Sore Mouth: C35D1(n= 0, 11)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	NA	NA	Not reported	Not reported	Data not reported because no participant was evaluated for this category
Atezolizumab	6.06	13.48	Not reported	Not reported	Not reported

Sore Mouth: C36D1(n= 0, 8)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	NA	NA	Not reported	Not reported	Data not reported because no participant was evaluated for this category
Atezolizumab	4.17	11.78	Not reported	Not reported	Not reported

Sore Mouth: C37D1(n= 0, 5)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	NA	NA	Not reported	Not reported	Data not reported because no participant was evaluated for this category
Atezolizumab	13.33	29.81	Not reported	Not reported	Not reported

Sore Mouth: C38D1(n= 0, 2)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	NA	NA	Not reported	Not reported	Data not reported because no participant was evaluated for this category
Atezolizumab	0.00	0.00	Not reported	Not reported	Not reported

Sore Mouth: EOT(n= 265, 243)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	11.57	22.85	Not reported	Not reported	Not reported
Atezolizumab	7.00	17.18	Not reported	Not reported	Not reported

Sore Mouth: Pro Week 6 Pd(n= 0,1)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	NA	NA	Not reported	Not reported	Data not reported because no participant was evaluated for this category
Atezolizumab	66.67	NA	Not reported	Not reported	Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.

Sore Mouth: Survival FU 1 (n= 2, 1)

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel	16.67	23.57	Not reported	Not reported	Not reported
Atezolizumab	0.00	NA	Not reported	Not reported	Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.

Complete source fields

classes

categories
measurements
group Id
OG000
spread
16.34
value
5.68
group Id
OG001
spread
15.32
value
4.95
title
Sore Mouth: Baseline (n= 387, 404)
categories
measurements
group Id
OG000
spread
25.75
value
15.52
group Id
OG001
spread
18.17
value
7.10
title
Sore Mouth: C2D1(n= 335, 357)
categories
measurements
group Id
OG000
spread
23.59
value
14.29
group Id
OG001
spread
14.18
value
5.61
title
Sore Mouth: C3D1(n= 252, 297)
categories
measurements
group Id
OG000
spread
22.95
value
14.00
group Id
OG001
spread
13.99
value
4.81
title
Sore Mouth: C4D1(n= 219, 270)
categories
measurements
group Id
OG000
spread
19.65
value
11.31
group Id
OG001
spread
13.49
value
4.27
title
Sore Mouth: C5D1(n= 165, 234)
categories
measurements
group Id
OG000
spread
23.24
value
13.29
group Id
OG001
spread
13.89
value
4.13
title
Sore Mouth: C6D1(n= 148, 218)
categories
measurements
group Id
OG000
spread
20.77
value
9.20
group Id
OG001
spread
15.50
value
5.59
title
Sore Mouth: C7D1(n= 87, 185)
categories
measurements
group Id
OG000
spread
16.73
value
8.57
group Id
OG001
spread
14.96
value
5.02
title
Sore Mouth: C8D1(n=70, 166)
categories
measurements
group Id
OG000
spread
17.42
value
6.00
group Id
OG001
spread
14.06
value
3.09
title
Sore Mouth: C9D1(n= 50, 151)
categories
measurements
group Id
OG000
spread
15.44
value
7.09
group Id
OG001
spread
14.53
value
3.96
title
Sore Mouth: C10D1(n= 47, 143)
categories
measurements
group Id
OG000
spread
13.97
value
4.50
group Id
OG001
spread
12.35
value
3.33
title
Sore Mouth: C11D1(n= 37, 130)
categories
measurements
group Id
OG000
spread
8.46
value
2.22
group Id
OG001
spread
14.87
value
4.65
title
Sore Mouth: C12D1(n= 30, 129)

denoms

counts
group Id
OG000
value
425
group Id
OG001
value
425
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
id
OG000
title
Docetaxel
description
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
id
OG001
title
Atezolizumab

param Type

MEAN

population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

reporting Status

POSTED

time Frame

Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

title

EORTC QLQ-LC13 Questionnaire Score: Sore Mouth

type

SECONDARY

unit Of Measure

Units on a scale

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Preserved source evidence · Not medical advice