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    Clinical Trial Results:
    A Phase III, Open-Label Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti−PD-L1 Antibody) Compared With Docetaxel in Patients With Non−Small Cell Lung Cancer After Failure With Platinum-Containing Chemotherapy (OAK)

    Summary
    EudraCT number
    		 2013-003331-30
    Trial protocol
    		 AT   SE   FI   IT   DE   PT   HU   NL   ES   PL   GR   FR  
    Global end of trial date
    09 Jan 2019

    Results information
    Results version number
    		 v3(current)
    This version publication date
    22 Dec 2019
    First version publication date
    26 May 2017
    Other versions
    		 v1 , v2
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    GO28915
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02008227
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F.Hoffmann-La Roche Ltd., Roche Trial Information Hotline, 41 61 6878333, global.trial_information@roche.com
    Scientific contact
    F.Hoffmann-La Roche Ltd., Roche Trial Information Hotline, 41 61 6878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Jun 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jan 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This was a Phase III, open-label, multicenter, randomized study to investigate the efficacy (an improved overall survival [OS] as primary objective) and safety of atezolizumab (an anti-programmed death−ligand 1 [anti-PD-L1] antibody) compared with docetaxel in participants with non−small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy.
    Protection of trial subjects
    This study was conducted in accordance with the International Conference on Harmonisation (ICH)-E6 guideline for Good Clinical Practice, or the laws and regulations of the country in which the research was conducted, whichever affords the greater protection to the individual. The investigators were trained according to applicable sponsor standard operating procedures.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Mar 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 27 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 330
    Country: Number of subjects enrolled
    France: 114
    Country: Number of subjects enrolled
    Spain: 112
    Country: Number of subjects enrolled
    Japan: 101
    Country: Number of subjects enrolled
    Germany: 92
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 85
    Country: Number of subjects enrolled
    Italy: 79
    Country: Number of subjects enrolled
    Poland: 54
    Country: Number of subjects enrolled
    United Kingdom: 31
    Country: Number of subjects enrolled
    Turkey: 26
    Country: Number of subjects enrolled
    Hungary: 20
    Country: Number of subjects enrolled
    Chile: 19
    Country: Number of subjects enrolled
    New Zealand: 17
    Country: Number of subjects enrolled
    Thailand: 16
    Country: Number of subjects enrolled
    Norway: 16
    Country: Number of subjects enrolled
    Canada: 15
    Country: Number of subjects enrolled
    Taiwan: 14
    Country: Number of subjects enrolled
    Switzerland: 13
    Country: Number of subjects enrolled
    Portugal: 12
    Country: Number of subjects enrolled
    Finland: 9
    Country: Number of subjects enrolled
    Netherlands: 8
    Country: Number of subjects enrolled
    Ukraine: 8
    Country: Number of subjects enrolled
    Greece: 8
    Country: Number of subjects enrolled
    Austria: 5
    Country: Number of subjects enrolled
    Russian Federation: 5
    Country: Number of subjects enrolled
    Serbia: 5
    Country: Number of subjects enrolled
    Brazil: 4
    Country: Number of subjects enrolled
    Guatemala: 4
    Country: Number of subjects enrolled
    Argentina: 1
    Country: Number of subjects enrolled
    Panama: 1
    Country: Number of subjects enrolled
    Sweden: 1
    Worldwide total number of subjects
    1225
    EEA total number of subjects
    561
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    661
    From 65 to 84 years
    562
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Twelve hundred and twenty-five participants were randomized in the study and were considered the Secondary Population (SP), out of which first 850 randomized participants were considered the Primary Population (PP).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Docetaxel
    Arm 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.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Docetaxel was administered 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.

    Arm title
    		 Atezolizumab
    Arm description
    		 Atezolizumab 1200 milligrams (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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    Other name
    MPDL3280A
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab 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.

    Number of subjects in period 1
    		Docetaxel Atezolizumab
    Started
    612
    613
    Completed
    0
    0
    Not completed
    612
    613
         Consent withdrawn by subject
    67
    36
         Study Terminated By Sponsor
    44
    83
         Death
    494
    485
         Lost to follow-up
    7
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Docetaxel
    Reporting group 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.

    Reporting group title
    Atezolizumab
    Reporting group description
    		 Atezolizumab 1200 milligrams (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.

    Reporting group values
    		 Docetaxel Atezolizumab Total
    Number of subjects
    		 612 613 1225
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.9 ( 9.2 ) 62.7 ( 9.8 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 233 234 467
        Male
    		 379 379 758
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 2 1 3
        Asian
    		 125 124 249
        Black or African American
    		 16 11 27
        Native Hawaiian or other Pacific Islander
    		 2 3 5
        White
    		 432 438 870
        Other
    		 12 11 23
        Multiple
    		 1 2 3
        Unknown
    		 22 23 45
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 42 48 90
        Not Hispanic or Latino
    		 541 540 1081
        Not reported
    		 21 14 35
        Unknown
    		 8 11 19

    End points

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    End points reporting groups
    Reporting group title
    Docetaxel
    Reporting group 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.

    Reporting group title
    Atezolizumab
    Reporting group description
    		 Atezolizumab 1200 milligrams (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.

    Primary: Percentage of Participants Who Died: Primary Population PP-ITT

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    End point title
    		 Percentage of Participants Who Died: Primary Population PP-ITT [1]
    End point description
    PP-ITT analysis set included the first 850 randomized ITT participants regardless of whether they received any study drug.
    End point type
    Primary
    End point timeframe
    Baseline until death due to any cause (up to approximately 2.25 years)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses for this end point
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Percentage of Participants
        number (not applicable)
    70.1
    63.8
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP

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    End point title
    		 Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP [2]
    End point description
    TC1=presence of discernible PD-L1 staining of any intensity in >/=1% & <5% TCs;TC2:presence of discernible PD-L1 staining of any intensity in >/=5% & <50% TCs;TC3=presence of discernible PD-L1 staining of any intensity in >/=50% TCs;IC1=presence of discernible PD-L1 staining of any intensity in ICs covering between >/=1% & <5% of tumor area occupied by tumor cells,associated intratumoral & contiguous peri-tumoral desmoplastic stroma;IC2=presence of discernible PD-L1 staining of any intensity in ICs covering between >/=5% & <10% of tumor area occupied by tumor cells,associated intratumoral & contiguous peri-tumoral desmoplastic stroma; IC3=presence of discernible PD-L1 staining of any intensity in ICs covering >/=10% of tumor area occupied by tumor cells,associated intratumoral & contiguous peri-tumoral desmoplastic stroma. TC1/2/3 or IC1/2/3 subgroup within PP included ITT participants with the corresponding PD-L1 expression status.
    End point type
    Primary
    End point timeframe
    Baseline until death due to any cause (up to approximately 2.25 years)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses for this end point
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    222
    241
    Units: Percentage of Participants
        number (not applicable)
    67.1
    62.7
    No statistical analyses for this end point

    Primary: Overall Survival (OS): PP-ITT

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    End point title
    		 Overall Survival (OS): PP-ITT
    End point description
    OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology. The PP-ITT analysis set.
    End point type
    Primary
    End point timeframe
    Baseline until death due to any cause (up to approximately 2.25 years)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Months
        median (confidence interval 95%)
    9.6 (8.6 to 11.2)
    13.8 (11.8 to 15.7)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    850
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 0.87
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Unstratified Analysis
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    850
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 0.86

    Primary: OS: TC1/2/3 or IC1/2/3 Subgroup of PP

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    End point title
    		 OS: TC1/2/3 or IC1/2/3 Subgroup of PP
    End point description
    OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology. TC1/2/3 or IC1/2/3 subgroup of PP.
    End point type
    Primary
    End point timeframe
    Baseline until death due to any cause (up to approximately 2.25 years)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    222
    241
    Units: Months
        median (confidence interval 95%)
    10.3 (8.8 to 12.0)
    15.7 (12.6 to 18.0)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    463
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0102
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 0.93
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Unstratified Analysis
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    463
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0052
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 0.91

    Primary: OS: SP-ITT

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    End point title
    		 OS: SP-ITT
    End point description
    OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology. Secondary population (SP) ITT analysis set included all 1225 randomized participants regardless of whether they received any study drug.
    End point type
    Primary
    End point timeframe
    Baseline until death due to any cause (up to approximately 2.87 years)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    612
    613
    Units: Months
        median (confidence interval 95%)
    9.8 (8.8 to 11.3)
    13.3 (11.3 to 14.9)
    Statistical analysis title
    		 Statistical Analysis SP-ITT
    Statistical analysis description
    Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    1225
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0012
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 0.92

    Primary: OS: TC1/2/3 or IC1/2/3 Subgroup of SP

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    End point title
    		 OS: TC1/2/3 or IC1/2/3 Subgroup of SP
    End point description
    OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology. TC1/2/3 Or IC1/2/3 Subgroup of SP analysis set.
    End point type
    Primary
    End point timeframe
    Baseline until death from any cause (approximately 2.87 years)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    337
    347
    Units: Months
        median (confidence interval 95%)
    10.8 (9.3 to 12.0)
    14.3 (12.4 to 16.7)
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    684
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0045
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 0.92

    Primary: OS: TC2/3 or IC2/3 Subgroup of SP

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    End point title
    		 OS: TC2/3 or IC2/3 Subgroup of SP
    End point description
    OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology. TC2/3 or IC2/3 Subgroup of SP analysis set.
    End point type
    Primary
    End point timeframe
    Baseline until death due to any cause (up to approximately 2.87 years)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    182
    168
    Units: Months
        median (confidence interval 95%)
    11.4 (9.3 to 12.9)
    16.6 (13.6 to 20.1)
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    350
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0012
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 0.84

    Primary: OS: TC3 or IC3 Subgroup of SP

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    End point title
    		 OS: TC3 or IC3 Subgroup of SP
    End point description
    OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology. TC3 or IC3 Subgroup of SP analysis set.
    End point type
    Primary
    End point timeframe
    Baseline until death due to any cause (up to approximately 2.87 years)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    85
    89
    Units: Months
        median (confidence interval 95%)
    9.7 (7.9 to 11.6)
    20.5 (16.8 to 30.2)
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    174
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 0.68

    Secondary: Percentage of Participants With Disease Progression (PD) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death: PP-ITT

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    End point title
    		 Percentage of Participants With Disease Progression (PD) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death: PP-ITT
    End point description
    PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeters (mm), or presence of new lesions. The PP-ITT analysis set.
    End point type
    Secondary
    End point timeframe
    Baseline up to PD or Death (up to approximately 2.25 years)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Percentage of Participants
        number (not applicable)
    88.2
    89.4
    No statistical analyses for this end point

    Secondary: Percentage of Participants With PD as Determined by Investigator Using RECIST v1.1 or Death: TC1/2/3 or IC1/2/3 Subgroup of PP

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    End point title
    		 Percentage of Participants With PD as Determined by Investigator Using RECIST v1.1 or Death: TC1/2/3 or IC1/2/3 Subgroup of PP
    End point description
    PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions. TC1/2/3 or IC1/2/3 subgroup of PP.
    End point type
    Secondary
    End point timeframe
    Baseline up to PD or Death (up to approximately 2.25 years)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    222
    241
    Units: Percentage of Participants
        number (not applicable)
    86.9
    89.6
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT

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    End point title
    		 Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT
    End point description
    PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions. The PP-ITT analysis set.
    End point type
    Secondary
    End point timeframe
    Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Months
        median (confidence interval 95%)
    4.0 (3.3 to 4.2)
    2.8 (2.6 to 3.0)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    850
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4928
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.1
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Unstratified Analysis
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    850
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3596
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.08

    Secondary: PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP

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    End point title
    		 PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
    End point description
    PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions. The TC1/2/3 or IC1/2/3 subgroup of PP.
    End point type
    Secondary
    End point timeframe
    Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    222
    241
    Units: Months
        median (confidence interval 95%)
    4.1 (2.9 to 4.3)
    2.8 (2.6 to 4.0)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    463
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3806
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.12
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Unstratified Analysis
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    463
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3249
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.1

    Secondary: Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT

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    End point title
    		 Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT
    End point description
    Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions. The PP-ITT analysis set.
    End point type
    Secondary
    End point timeframe
    Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Percentage of Participants
        number (confidence interval 95%)
    13.4 (10.32 to 17.02)
    13.6 (10.53 to 17.28)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP

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    End point title
    		 Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
    End point description
    Objective response (OR) is defined as a CR or PR as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions. The TC1/2/3 or IC1/2/3 subgroup of PP.
    End point type
    Secondary
    End point timeframe
    Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    222
    241
    Units: Percentage of Participants
        number (confidence interval 95%)
    16.2 (11.62 to 21.74)
    17.8 (13.22 to 23.27)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT

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    End point title
    		 Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT
    End point description
    DOR:Duration from first tumor assessment that supports the participant's OR to PD or death due to any cause.CR:complete disappearance of all target lesions&non-target disease.All nodes,both target&non-target,must decrease to normal.No new lesions.PR:At least 30% decrease in sum of the diameters of all target&all new measurable lesions,taking as reference the baseline sum of diameters,in absence of CR.Participants without PD at time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at randomization date plus 1 day.PD:at least 20% increase in sum of diameters of target lesions compared to the smallest sum of diameters on-study&absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.’99999’:due to higher number of censored participants data not estimable. PP-ITT analysis set.
    End point type
    Secondary
    End point timeframe
    From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    57
    58
    Units: Months
        median (confidence interval 95%)
    6.2 (4.9 to 7.6)
    16.3 (10.0 to 99999)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.18
         upper limit
    		 0.55
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Unstratified Analysis
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.21
         upper limit
    		 0.55

    Secondary: DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP

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    End point title
    		 DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
    End point description
    DOR:Duration from first tumor assessment that supports the participant's OR to PD or death due to any cause.CR:complete disappearance of all target lesions&non-target disease.All nodes,both target&non-target,must decrease to normal.No new lesions.PR:At least 30% decrease in sum of the diameters of all target&all new measurable lesions,taking as reference the baseline sum of diameters,in absence of CR.Participants without PD at time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at randomization date plus 1 day.PD:at least 20% increase in sum of diameters of target lesions compared to the smallest sum of diameters on-study&absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.’99999’:due to higher number of censored participants data not estimable. TC1/2/3 or IC1/2/3 Subgroup of PP.
    End point type
    Secondary
    End point timeframe
    From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    36
    43
    Units: Months
        median (confidence interval 95%)
    6.2 (4.9 to 9.2)
    16.0 (9.7 to 99999)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0006
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.15
         upper limit
    		 0.62
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Unstratified Analysis
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.22
         upper limit
    		 0.65

    Secondary: Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab

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    End point title
    		 Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab [3]
    End point description
    ATA evaluable population included all participants who received atezolizumab treatment and had at least one post treatment ATA result.
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 2.25 years (assessed at predose [Hour {Hr} 0] on Day 1 of Cycles 1, 2, 3, 4, 8, 16, then every 8 cycles up to end of treatment (EOT) [approximately 2.25 years]; 120 days after EOT [approximately 2.25 years] [1 Cycle=21 days])
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses for this end point
    End point values
    		 Atezolizumab
    Number of subjects analysed
    565
    Units: Percentage of Participants
        number (not applicable)
    30.4
    No statistical analyses for this end point

    Secondary: Maximum Observed Serum Atezolizumab Concentration (Cmax)

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    End point title
    		 Maximum Observed Serum Atezolizumab Concentration (Cmax) [4]
    End point description
    Pharmacokinetic (PK) evaluable population included participants who received atezolizumab treatment and had at least one measurable PK concentration.
    End point type
    Secondary
    End point timeframe
    Predose (Hr 0), 30 minutes (min) post-infusion (infusion duration: 60 min) on Cycle 1 Day 1 (1 Cycle=21 days)
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses for this end point
    End point values
    		 Atezolizumab
    Number of subjects analysed
    606
    Units: Micrograms per milliliter (mcg/mL)
        arithmetic mean (standard deviation)
    400 ( 127 )
    No statistical analyses for this end point

    Secondary: Minimum Observed Serum Atezolizumab Concentration (Cmin)

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    End point title
    		 Minimum Observed Serum Atezolizumab Concentration (Cmin) [5]
    End point description
    PK evaluable participants. Here, 'n' signifies those participants evaluated for this measure at specific time point. All 606 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
    End point type
    Secondary
    End point timeframe
    Predose (Hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24, 32, EOT (approximately 2.25 years); 120 days after EOT (approximately 2.25 years) (1 Cycle=21 days)
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses for this end point
    End point values
    		 Atezolizumab
    Number of subjects analysed
    606
    Units: mcg/mL
    arithmetic mean (standard deviation)
        C1D1 (n= 593)
    2.59 ( 30.9 )
        C2D1 (n= 534)
    83.2 ( 31.0 )
        C3D1 (n= 445)
    130 ( 55.8 )
        C4D1 (n= 405)
    158 ( 66.4 )
        C8D1 (n= 222)
    205 ( 99.4 )
        C16D1 (n= 132)
    226 ( 105 )
        C24D1 (n= 63)
    250 ( 99.8 )
        C32D1 (n= 11)
    277 ( 117 )
        EOT (n= 347)
    144 ( 101 )
        120 days after EOT (n= 124)
    10.4 ( 20.0 )
    No statistical analyses for this end point

    Secondary: Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)

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    End point title
    		 Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)
    End point description
    TTD in patient-reported lung cancer symptoms (pain in chest or in arm/shoulder, dyspnea, or cough) was a composite endpoint defined as the time from randomization to the earliest time the participant’s scale scores showed a 10 point or greater increase after baseline in any of the symptoms. A >/=10-point change in the score perceived by participants was considered as clinically significant. The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity. The PP-ITT analysis set. 99999 denotes the data not reported because upper limit of CI was not estimable due to higher number of censored participants.
    End point type
    Secondary
    End point timeframe
    Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Months
    median (confidence interval 95%)
        Pain in Chest
    8.3 (4.6 to 12.5)
    18.0 (11.0 to 99999)
        Cough
    5.6 (4.0 to 12.8)
    5.5 (4.2 to 7.9)
        Dyspnoea
    2.1 (1.6 to 2.3)
    1.8 (1.5 to 2.3)
        Arm/Shoulder Pain
    6.2 (4.9 to 14.7)
    8.3 (5.8 to 12.8)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Pain in Chest: Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    850
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0111
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 0.93
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Cough: Unstratified Analysis
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    850
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6305
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.33
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Dyspnoea: Unstratified Analysis
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    850
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7406
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.16
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Arm/Shoulder Pain: Unstratified Analysis
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    850
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5221
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.17

    Secondary: EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items

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    End point title
    		 EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
    End point description
    EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional (Fx) scales (physical, role, cognitive, emotional, social), symptom (Sx) scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions on 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were 7-point scale (1/Very Poor to 7/Excellent). For instrument, GHS/QOL and Fx scales linearly transformed so each score 0-100; lower scores=poorer Fx (worsening), higher scores=better Fx (improvement). Sx scales/items also linearly transformed so each score 0-100; higher scores=worse Sx (more severe/worsened), lower scores=less Sx (less severe/improvement). PP-ITT analysis set. ’n’=subjects evaluated at specific timepoint for each group. '99999'=standard deviation (SD) non-estimable due to 1 participant evaluated. '00000'=data not reported due to no participant evaluated.
    End point type
    Secondary
    End point timeframe
    Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Appetite Loss: Baseline (n= 390, 413)
    26.58 ( 31.57 )
    22.92 ( 29.41 )
        Appetite Loss: C2D1(n= 342, 368)
    27.49 ( 30.39 )
    26.99 ( 31.16 )
        Appetite Loss: C3D1(n= 256, 304)
    21.35 ( 28.84 )
    21.16 ( 28.94 )
        Appetite Loss: C4D1(n= 224, 279)
    18.75 ( 25.36 )
    18.40 ( 26.60 )
        Appetite Loss: C5D1(n= 166, 238)
    18.88 ( 23.89 )
    16.67 ( 27.52 )
        Appetite Loss: C6D1(n= 151, 224)
    18.98 ( 25.68 )
    14.88 ( 25.39 )
        Appetite Loss: C7D1(n= 88, 190)
    15.91 ( 24.75 )
    12.46 ( 23.06 )
        Appetite Loss: C8D1(n= 72, 170)
    13.89 ( 22.20 )
    12.94 ( 23.27 )
        Appetite Loss: C9D1(n= 50, 153)
    8.00 ( 18.52 )
    11.33 ( 22.35 )
        Appetite Loss: C10D1(n= 47, 146)
    7.80 ( 15.87 )
    12.33 ( 21.45 )
        Appetite Loss: C11D1(n= 37, 134)
    11.71 ( 23.85 )
    11.44 ( 22.43 )
        Appetite Loss: C12D1(n= 30, 132)
    11.11 ( 20.22 )
    8.84 ( 18.81 )
        Appetite Loss: C13D1(n= 19, 123)
    10.53 ( 15.92 )
    8.40 ( 15.74 )
        Appetite Loss: C14D1(n= 18, 120)
    7.41 ( 14.26 )
    10.00 ( 17.61 )
        Appetite Loss: C15D1(n= 16, 113)
    6.25 ( 13.44 )
    12.39 ( 22.80 )
        Appetite Loss: C16D1(n= 13, 109)
    7.69 ( 14.62 )
    10.09 ( 19.51 )
        Appetite Loss: C17D1(n= 11, 98)
    6.06 ( 13.48 )
    7.82 ( 18.41 )
        Appetite Loss: C18D1(n= 10, 91)
    6.67 ( 14.05 )
    8.06 ( 18.15 )
        Appetite Loss: C19D1(n= 9, 84)
    7.41 ( 14.70 )
    9.13 ( 18.18 )
        Appetite Loss: C20D1(n= 9, 80)
    11.11 ( 23.57 )
    9.58 ( 21.34 )
        Appetite Loss: C21D1(n= 9, 75)
    3.70 ( 11.11 )
    12.44 ( 26.15 )
        Appetite Loss: C22D1(n= 8, 69)
    8.33 ( 15.43 )
    6.76 ( 16.74 )
        Appetite Loss: C23D1(n= 8, 66)
    8.33 ( 15.43 )
    7.58 ( 17.34 )
        Appetite Loss: C24D1(n= 5, 64)
    13.33 ( 18.26 )
    8.33 ( 15.71 )
        Appetite Loss: C25D1(n= 3, 60)
    0.00 ( 0.00 )
    6.11 ( 13.01 )
        Appetite Loss: C26D1(n= 3, 55)
    22.22 ( 19.24 )
    5.45 ( 12.45 )
        Appetite Loss: C27D1(n= 3, 52)
    0.00 ( 0.00 )
    9.62 ( 19.06 )
        Appetite Loss: C28D1(n= 1, 49)
    0.00 ( 99999 )
    7.48 ( 15.61 )
        Appetite Loss: C29D1(n= 2, 40)
    33.33 ( 47.14 )
    9.17 ( 16.86 )
        Appetite Loss: C30D1(n= 1, 31)
    0.00 ( 99999 )
    1.08 ( 5.99 )
        Appetite Loss: C31D1(n= 0, 24)
    00000 ( 00000 )
    6.94 ( 13.83 )
        Appetite Loss: C32D1(n= 0, 22)
    00000 ( 00000 )
    7.58 ( 22.84 )
        Appetite Loss: C33D1(n= 0,16)
    00000 ( 00000 )
    8.33 ( 25.82 )
        Appetite Loss: C34D1(n= 0, 14)
    00000 ( 00000 )
    4.76 ( 17.82 )
        Appetite Loss: C35D1(n= 0, 12)
    00000 ( 00000 )
    8.33 ( 20.72 )
        Appetite Loss: C36D1(n= 0, 8)
    00000 ( 00000 )
    4.17 ( 11.78 )
        Appetite Loss: C37D1(n= 0, 5)
    00000 ( 00000 )
    6.67 ( 14.91 )
        Appetite Loss: C38D1(n= 0, 2)
    00000 ( 00000 )
    0.00 ( 0.00 )
        Appetite Loss: End of treatment (EOT)(n= 265, 246)
    29.81 ( 31.85 )
    31.98 ( 33.51 )
        Appetite Loss: Pro Week 6 Pd(n= 0,1)
    00000 ( 00000 )
    33.33 ( 99999 )
        Appetite Loss: Survival Follow-up (FU) 1 (n= 2, 1)
    50.00 ( 70.71 )
    66.67 ( 99999 )
        Constipation: Baseline (n= 388, 410)
    19.93 ( 27.39 )
    16.50 ( 26.81 )
        Constipation: C2D1(n= 339, 363)
    19.47 ( 26.42 )
    18.09 ( 26.92 )
        Constipation: C3D1(n= 255, 304)
    19.74 ( 26.91 )
    15.13 ( 23.71 )
        Constipation: C4D1(n= 224, 277)
    17.86 ( 23.38 )
    14.56 ( 23.58 )
        Constipation: C5D1(n= 166, 236)
    13.05 ( 21.33 )
    12.15 ( 21.16 )
        Constipation: C6D1(n= 151, 225)
    14.35 ( 23.89 )
    12.89 ( 22.42 )
        Constipation: C7D1(n= 87, 188)
    13.41 ( 20.62 )
    11.52 ( 21.04 )
        Constipation: C8D1(n= 72, 171)
    8.33 ( 15.57 )
    12.28 ( 21.36 )
        Constipation: C9D1(n= 50, 153)
    9.33 ( 19.10 )
    10.68 ( 17.79 )
        Constipation: C10D1(n= 47, 146)
    9.22 ( 17.99 )
    9.82 ( 17.58 )
        Constipation: C11D1(n= 37, 134)
    5.41 ( 12.46 )
    9.95 ( 17.83 )
        Constipation: C12D1(n= 30, 132)
    11.11 ( 20.22 )
    10.86 ( 18.65 )
        Constipation: C13D1(n= 19, 124)
    5.26 ( 12.49 )
    8.60 ( 15.83 )
        Constipation: C14D1(n= 17, 121)
    15.69 ( 23.91 )
    9.09 ( 16.67 )
        Constipation: C15D1(n= 15, 113)
    2.22 ( 8.61 )
    10.03 ( 17.75 )
        Constipation: C16D1(n= 13, 109)
    20.51 ( 32.03 )
    9.79 ( 18.87 )
        Constipation: C17D1(n= 11, 98)
    12.12 ( 22.47 )
    9.86 ( 19.27 )
        Constipation: C18D1(n= 10, 92)
    6.67 ( 14.05 )
    9.06 ( 17.89 )
        Constipation: C19D1(n= 9, 83)
    7.41 ( 14.70 )
    9.64 ( 18.43 )
        Constipation: C20D1(n=9, 80)
    14.81 ( 33.79 )
    12.50 ( 23.35 )
        Constipation: C21D1(n= 9, 75)
    7.41 ( 14.70 )
    14.22 ( 25.22 )
        Constipation: C22D1(n= 8, 69)
    12.50 ( 24.80 )
    11.59 ( 21.26 )
        Constipation: C23D1(n= 8, 66)
    4.17 ( 11.78 )
    10.10 ( 20.23 )
        Constipation: C24D1(n=5, 65)
    20.00 ( 29.81 )
    9.74 ( 17.40 )
        Constipation: C25D1(n= 3, 60)
    0.00 ( 0.00 )
    11.11 ( 19.08 )
        Constipation: C26D1(n= 2, 55)
    0.00 ( 0.00 )
    12.12 ( 20.65 )
        Constipation: C27D1(n= 3, 52)
    0.00 ( 0.00 )
    13.46 ( 20.09 )
        Constipation: C28D1(n= 1, 48)
    0.00 ( 99999 )
    11.81 ( 22.27 )
        Constipation: C29D1(n= 2, 40)
    50.00 ( 70.71 )
    15.83 ( 23.86 )
        Constipation: C30D1(n= 1, 31)
    0.00 ( 99999 )
    8.60 ( 19.18 )
        Constipation: C31D1(n= 0, 24)
    00000 ( 00000 )
    9.72 ( 20.80 )
        Constipation: C32D1(n= 0, 22)
    00000 ( 00000 )
    6.06 ( 13.16 )
        Constipation: C33D1(n= 0, 16)
    00000 ( 00000 )
    4.17 ( 11.39 )
        Constipation: C34D1(n= 0, 14)
    00000 ( 00000 )
    7.14 ( 14.19 )
        Constipation: C35D1(n= 0, 12)
    00000 ( 00000 )
    5.56 ( 12.97 )
        Constipation: C36D1(n= 0, 8)
    00000 ( 00000 )
    4.17 ( 11.78 )
        Constipation: C37D1(n= 0, 5)
    00000 ( 00000 )
    0.00 ( 0.00 )
        Constipation: C38D1(n= 0, 2)
    00000 ( 00000 )
    0.00 ( 0.00 )
        Constipation: EOT (n= 265, 246)
    19.12 ( 27.28 )
    19.78 ( 28.36 )
        Constipation: Pro Week 6 Pd(n= 0,1)
    00000 ( 00000 )
    66.67 ( 99999 )
        Constipation: Survival FU-1 (n= 2,1)
    33.33 ( 47.14 )
    66.67 ( 99999 )
        Diarrhea: Baseline (n= 388, 411)
    5.84 ( 13.77 )
    7.22 ( 17.86 )
        Diarrhea: C2D1(n= 339, 361)
    11.21 ( 20.65 )
    7.29 ( 17.72 )
        Diarrhea: C3D1(n= 255, 304)
    10.07 ( 18.68 )
    6.14 ( 15.75 )
        Diarrhea: C4D1(n= 223, 280)
    8.22 ( 16.35 )
    6.67 ( 17.71 )
        Diarrhea: C5D1(n= 166, 238)
    8.43 ( 17.48 )
    6.58 ( 16.16 )
        Diarrhea: C6D1(n= 151, 222)
    7.51 ( 14.99 )
    6.31 ( 14.88 )
        Diarrhea: C7D1(n= 87, 189)
    10.34 ( 17.10 )
    7.94 ( 17.24 )
        Diarrhea: C8D1(n= 72, 171)
    7.41 ( 15.03 )
    8.77 ( 17.56 )
        Diarrhea: C9D1(n= 50, 153)
    11.33 ( 17.31 )
    7.63 ( 16.44 )
        Diarrhea: C10D1(n= 47, 146)
    7.80 ( 14.27 )
    5.48 ( 15.67 )
        Diarrhea: C11D1(n= 36, 134)
    8.33 ( 14.64 )
    4.98 ( 14.46 )
        Diarrhea: C12D1(n= 30, 132)
    10.00 ( 17.83 )
    6.31 ( 16.54 )
        Diarrhea: C13D1(n= 18, 124)
    11.11 ( 16.17 )
    5.65 ( 14.55 )
        Diarrhea: C14D1(n= 17, 121)
    3.92 ( 11.07 )
    9.92 ( 19.07 )
        Diarrhea: C15D1(n= 15, 113)
    8.89 ( 15.26 )
    7.96 ( 17.97 )
        Diarrhea: C16D1(n= 12, 108)
    13.89 ( 17.16 )
    6.48 ( 14.02 )
        Diarrhea: C17D1(n= 11, 98)
    9.09 ( 15.57 )
    7.82 ( 16.44 )
        Diarrhea: C18D1(n= 10, 92)
    13.33 ( 17.21 )
    8.70 ( 17.73 )
        Diarrhea: C19D1(n= 9, 84)
    14.81 ( 17.57 )
    7.94 ( 18.38 )
        Diarrhea: C20D1(n= 9, 80)
    7.41 ( 14.70 )
    6.67 ( 14.43 )
        Diarrhea: C21D1(n= 9, 75)
    18.52 ( 17.57 )
    11.11 ( 18.45 )
        Diarrhea: C22D1(n= 8, 68)
    16.67 ( 25.20 )
    7.84 ( 16.41 )
        Diarrhea: C23D1(n= 8, 66)
    8.33 ( 15.43 )
    6.06 ( 16.44 )
        Diarrhea: C24D1(n= 5, 64)
    6.67 ( 14.91 )
    6.25 ( 16.67 )
        Diarrhea: C25D1(n= 3, 60)
    0.00 ( 0.00 )
    6.11 ( 14.38 )
        Diarrhea: C26D1(n= 3, 55)
    11.11 ( 19.24 )
    10.30 ( 21.15 )
        Diarrhea: C27D1(n= 3, 52)
    11.11 ( 19.24 )
    5.77 ( 15.79 )
        Diarrhea: C28D1(n= 1, 48)
    0.00 ( 99999 )
    4.86 ( 13.73 )
        Diarrhea: C29D1(n= 2, 40)
    50.00 ( 70.71 )
    9.17 ( 18.47 )
        Diarrhea: C30D1(n= 1, 31)
    0.00 ( 99999 )
    7.53 ( 16.58 )
        Diarrhea: C31D1(n= 0, 24)
    00000 ( 00000 )
    6.94 ( 16.97 )
        Diarrhea: C32D1(n= 0, 22)
    00000 ( 00000 )
    12.12 ( 16.41 )
        Diarrhea: C33D1(n= 0, 16)
    00000 ( 00000 )
    8.33 ( 14.91 )
        Diarrhea: C34D1(n= 0, 14)
    00000 ( 00000 )
    4.76 ( 12.10 )
        Diarrhea: C35D1(n= 0, 12)
    00000 ( 00000 )
    5.56 ( 12.97 )
        Diarrhea: C36D1(n= 0, 8)
    00000 ( 00000 )
    4.17 ( 11.78 )
        Diarrhea: C37D1(n= 0, 5)
    00000 ( 00000 )
    6.67 ( 14.91 )
        Diarrhea: C38D1(n= 0, 2)
    00000 ( 00000 )
    0.00 ( 0.00 )
        Diarrhea: EOT(n= 265, 246)
    10.57 ( 19.18 )
    9.35 ( 20.39 )
        Diarrhea: Pro Week 6 Pd(n= 0, 1)
    00000 ( 00000 )
    0.00 ( 99999 )
        Diarrhea: Survival FU-1 (n= 2, 1)
    33.33 ( 47.14 )
    33.33 ( 99999 )
        Financial Difficulties: Baseline (n=390, 413)
    20.76 ( 27.61 )
    18.09 ( 28.32 )
        Financial Difficulties: C2D1 (n=343, 369)
    18.45 ( 26.20 )
    15.93 ( 26.28 )
        Financial Difficulties: C3D1 (n=256, 304)
    16.86 ( 24.24 )
    15.63 ( 25.79 )
        Financial Difficulties: C4D1 (n=224, 278)
    16.74 ( 23.97 )
    15.12 ( 24.72 )
        Financial Difficulties: C5D1 (n=167, 238)
    16.57 ( 24.03 )
    15.13 ( 25.71 )
        Financial Difficulties: C6D1 (n=151, 225)
    15.66 ( 24.06 )
    16.67 ( 26.41 )
        Financial Difficulties: C7D1 (n=88, 190)
    16.28 ( 24.92 )
    17.46 ( 27.41 )
        Financial Difficulties: C8D1 (n=72, 170)
    13.15 ( 21.44 )
    18.82 ( 27.59 )
        Financial Difficulties: C9D1 (n=50, 153)
    16.33 ( 28.16 )
    17.54 ( 27.38 )
        Financial Difficulties: C10D1 (n=47, 145)
    14.49 ( 23.99 )
    17.81 ( 29.08 )
        Financial Difficulties: C11D1 (n=37, 134)
    9.26 ( 21.98 )
    19.65 ( 30.10 )
        Financial Difficulties: C12D1 (n=30, 132)
    12.22 ( 23.95 )
    18.43 ( 28.92 )
        Financial Difficulties: C13D1 (n=19, 124)
    12.96 ( 25.92 )
    18.31 ( 29.10 )
        Financial Difficulties: C14D1 (n=18, 121)
    15.69 ( 26.66 )
    18.46 ( 29.17 )
        Financial Difficulties: C15D1 (n=16, 113)
    6.67 ( 18.69 )
    18.29 ( 28.86 )
        Financial Difficulties: C16D1 (n=13, 109)
    13.89 ( 30.01 )
    18.65 ( 29.20 )
        Financial Difficulties: C17D1 (n=11, 98)
    15.15 ( 22.92 )
    18.37 ( 27.55 )
        Financial Difficulties: C18D1 (n=10, 92)
    10.00 ( 22.50 )
    19.57 ( 28.45 )
        Financial Difficulties: C19D1 (n=9, 84)
    3.70 ( 11.11 )
    19.05 ( 28.94 )
        Financial Difficulties: C20D1 (n=9, 80)
    11.11 ( 33.33 )
    18.75 ( 27.99 )
        Financial Difficulties: C21D1 (n=9, 75)
    11.11 ( 33.33 )
    23.11 ( 30.99 )
        Financial Difficulties: C22D1 (n=8, 68)
    12.50 ( 35.36 )
    18.63 ( 28.44 )
        Financial Difficulties: C23D1 (n=8, 66)
    9.52 ( 25.20 )
    21.72 ( 30.66 )
        Financial Difficulties: C24D1 (n=5, 64)
    13.33 ( 29.81 )
    20.83 ( 29.99 )
        Financial Difficulties: C25D1 (n=3, 60)
    0.00 ( 0.00 )
    21.67 ( 31.19 )
        Financial Difficulties: C26D1 (n=3, 55)
    0.00 ( 0.00 )
    20.00 ( 30.50 )
        Financial Difficulties: C27D1 (n=3, 52)
    0.00 ( 0.00 )
    17.31 ( 28.38 )
        Financial Difficulties: C28D1 (n=1, 48)
    0.00 ( 99999 )
    18.06 ( 26.59 )
        Financial Difficulties: C29D1 (n=2, 40)
    50.00 ( 70.71 )
    19.17 ( 28.13 )
        Financial Difficulties: C30D1 (n=1, 31)
    0.00 ( 99999 )
    17.20 ( 25.63 )
        Financial Difficulties: C31D1(n=0, 24)
    00000 ( 00000 )
    20.83 ( 25.66 )
        Financial Difficulties: C32D1(n=0, 22)
    00000 ( 00000 )
    21.21 ( 26.32 )
        Financial Difficulties: C33D1(n=0, 16)
    00000 ( 00000 )
    22.92 ( 29.11 )
        Financial Difficulties: C34D1(n=0, 14)
    00000 ( 00000 )
    26.19 ( 35.03 )
        Financial Difficulties: C35D1(n=0, 12)
    00000 ( 00000 )
    27.78 ( 37.15 )
        Financial Difficulties: C36D1(n=0, 8)
    00000 ( 00000 )
    8.33 ( 15.43 )
        Financial Difficulties: C37D1(n=0, 5)
    00000 ( 00000 )
    26.67 ( 43.46 )
        Financial Difficulties: C38D1(n=0, 2)
    00000 ( 00000 )
    16.67 ( 23.57 )
        Financial Difficulties: EOT(n=267, 245)
    21.80 ( 29.23 )
    19.46 ( 28.75 )
        Financial Difficulties: Pro Week 6 Pd (n=0, 1)
    00000 ( 00000 )
    33.33 ( 99999 )
        Financial Difficulties:Survival FU-1 (n=2,24)
    83.33 ( 23.57 )
    66.67 ( 99999 )
        Insomnia: Baseline (n= 388, 413)
    28.87 ( 30.55 )
    26.15 ( 28.72 )
        Insomnia: C2D1(n= 340, 367)
    27.55 ( 30.87 )
    26.52 ( 28.61 )
        Insomnia: C3D1(n= 253, 304)
    25.69 ( 29.15 )
    24.89 ( 27.32 )
        Insomnia: C4D1(n= 222, 279)
    21.32 ( 26.07 )
    23.66 ( 26.48 )
        Insomnia: C5D1(n= 166, 237)
    21.49 ( 25.43 )
    25.88 ( 29.84 )
        Insomnia: C6D1(n= 150, 225)
    22.00 ( 26.71 )
    23.41 ( 27.73 )
        Insomnia: C7D1(n= 87, 189)
    21.07 ( 25.47 )
    23.99 ( 26.65 )
        Insomnia: C8D1(n= 70, 169)
    15.24 ( 23.87 )
    23.87 ( 26.27 )
        Insomnia: C9D1(n= 49, 153)
    16.33 ( 26.46 )
    22.88 ( 27.16 )
        Insomnia: C10D1(n= 46, 144)
    13.77 ( 19.34 )
    21.53 ( 26.87 )
        Insomnia: C11D1(n= 36, 133)
    9.26 ( 18.87 )
    20.55 ( 27.44 )
        Insomnia: C12D1(n= 29, 132)
    16.09 ( 30.37 )
    21.46 ( 24.41 )
        Insomnia: C13D1(n= 17, 124)
    17.65 ( 29.15 )
    23.39 ( 28.51 )
        Insomnia: C14D1(n= 17, 121)
    25.49 ( 27.71 )
    23.69 ( 26.33 )
        Insomnia: C15D1(n= 15, 113)
    22.22 ( 29.99 )
    21.53 ( 28.84 )
        Insomnia: C16D1(n= 13, 108)
    20.51 ( 25.60 )
    21.60 ( 31.01 )
        Insomnia: C17D1(n= 11, 98)
    21.21 ( 26.97 )
    20.07 ( 28.21 )
        Insomnia: C18D1(n= 10, 92)
    20.00 ( 32.20 )
    21.38 ( 27.77 )
        Insomnia: C19D1(n= 9, 83)
    18.52 ( 24.22 )
    22.49 ( 28.09 )
        Insomnia: C20D1(n= 9, 80)
    18.52 ( 33.79 )
    20.83 ( 29.71 )
        Insomnia: C21D1(n= 9, 75)
    22.22 ( 33.33 )
    20.89 ( 29.90 )
        Insomnia: C22D1(n= 8, 69)
    16.67 ( 35.63 )
    18.84 ( 26.49 )
        Insomnia: C23D1(n= 8, 66)
    20.83 ( 35.36 )
    19.70 ( 28.03 )
        Insomnia: C24D1(n= 5, 64)
    26.67 ( 27.89 )
    19.79 ( 25.00 )
        Insomnia: C25D1(n= 3, 60)
    11.11 ( 19.24 )
    18.89 ( 23.26 )
        Insomnia: C26D1(n= 3, 55)
    11.11 ( 19.24 )
    21.21 ( 27.49 )
        Insomnia: C27D1(n= 3, 52)
    11.11 ( 19.24 )
    19.23 ( 28.27 )
        Insomnia: C28D1(n= 1, 49)
    0.00 ( 99999 )
    21.09 ( 27.80 )
        Insomnia: C29D1(n= 2, 40)
    33.33 ( 47.14 )
    21.67 ( 26.74 )
        Insomnia: C30D1(n= 1, 31)
    0.00 ( 99999 )
    20.43 ( 28.12 )
        Insomnia: C31D1(n= 0, 24)
    00000 ( 00000 )
    20.83 ( 27.47 )
        Insomnia: C32D1(n= 0, 22)
    00000 ( 00000 )
    19.70 ( 26.55 )
        Insomnia: C33D1(n= 0, 16)
    00000 ( 00000 )
    20.83 ( 34.16 )
        Insomnia: C34D1(n= 0, 14)
    00000 ( 00000 )
    23.81 ( 24.21 )
        Insomnia: C35D1(n= 0, 12)
    00000 ( 00000 )
    25.00 ( 28.87 )
        Insomnia: C36D1(n= 0, 8)
    00000 ( 00000 )
    25.00 ( 23.57 )
        Insomnia: C37D1(n= 0, 5)
    00000 ( 00000 )
    33.33 ( 23.57 )
        Insomnia: C38D1(n= 0, 2)
    00000 ( 00000 )
    16.67 ( 23.57 )
        Insomnia: Pro Week Pd(n= 0, 1)
    00000 ( 00000 )
    66.67 ( 99999 )
        Insomnia: Survival FU-1 (n= 2, 1)
    50.00 ( 70.71 )
    100.00 ( 99999 )
        Dyspnea: C1D1 (n= 389, 412)
    33.50 ( 31.11 )
    32.04 ( 28.73 )
        Dyspnea: C2D1 (n= 341, 368)
    32.55 ( 29.03 )
    31.88 ( 29.70 )
        Dyspnea: C3D1 (n= 255, 302)
    29.93 ( 27.54 )
    27.15 ( 26.73 )
        Dyspnea: C4D1 (n= 389, 277)
    28.38 ( 24.37 )
    28.28 ( 27.48 )
        Dyspnea: C5D1 (n= 222, 236)
    29.52 ( 24.46 )
    27.82 ( 27.03 )
        Dyspnea: C6D1 (n= 166, 222)
    30.02 ( 26.32 )
    26.88 ( 25.63 )
        Dyspnea: C7D1 (n= 151, 188)
    27.13 ( 25.31 )
    25.53 ( 25.99 )
        Dyspnea: C8D1 (n= 86, 169)
    28.70 ( 29.76 )
    26.43 ( 26.70 )
        Dyspnea: C9D1 (n= 72, 152)
    26.67 ( 28.57 )
    24.12 ( 24.92 )
        Dyspnea: C10D1 (n= 50, 146)
    27.66 ( 28.93 )
    23.52 ( 23.54 )
        Dyspnea: C11D1 (n= 47, 134)
    25.23 ( 30.84 )
    22.89 ( 25.00 )
        Dyspnea: C12D1 (n= 37, 132)
    26.67 ( 26.84 )
    22.73 ( 25.83 )
        Dyspnea: C13D1 (n= 30, 123)
    19.30 ( 23.08 )
    25.47 ( 26.68 )
        Dyspnea: C14D1 (n= 19, 119)
    20.37 ( 25.92 )
    21.85 ( 25.47 )
        Dyspnea: C15D1 (n= 16, 113)
    16.67 ( 17.21 )
    22.71 ( 24.51 )
        Dyspnea: C16D1 (n= 13, 109)
    20.51 ( 16.88 )
    21.71 ( 25.00 )
        Dyspnea: C17D1 (n= 11, 98)
    15.15 ( 17.41 )
    21.43 ( 23.57 )
        Dyspnea: C18D1 (n= 10, 92)
    20.00 ( 17.21 )
    22.83 ( 25.64 )
        Dyspnea: C19D1 (n= 9, 84)
    11.11 ( 16.67 )
    23.41 ( 23.59 )
        Dyspnea: C20D1 (n= 9, 80)
    18.52 ( 17.57 )
    21.67 ( 24.36 )
        Dyspnea: C21D1 (n= 9, 75)
    18.52 ( 17.57 )
    19.11 ( 20.63 )
        Dyspnea: C22D1 (n= 8, 68)
    20.83 ( 35.36 )
    20.59 ( 23.06 )
        Dyspnea: C23D1 (n= 8, 65)
    12.50 ( 17.25 )
    18.46 ( 21.27 )
        Dyspnea: C24D1 (n= 5, 64)
    6.67 ( 14.91 )
    19.79 ( 24.28 )
        Dyspnea: C25D1 (n= 3, 60)
    11.11 ( 19.24 )
    20.00 ( 22.30 )
        Dyspnea: C26D1 (n= 3, 55)
    0.00 ( 0.00 )
    20.00 ( 24.51 )
        Dyspnea: C27D1 (n= 3, 52)
    0.00 ( 0.00 )
    16.03 ( 19.23 )
        Dyspnea: C28D1 (n= 1, 49)
    0.00 ( 99999 )
    17.01 ( 20.55 )
        Dyspnea: C29D1 (n= 2, 40)
    33.33 ( 47.14 )
    15.00 ( 21.28 )
        Dyspnea: C30D1 (n= 1, 31)
    0.00 ( 99999 )
    16.13 ( 18.99 )
        Dyspnea: C31D1 (n= 0, 24)
    00000 ( 00000 )
    22.22 ( 23.40 )
        Dyspnea: C32D1 (n= 0, 22)
    00000 ( 00000 )
    22.73 ( 21.54 )
        Dyspnea: C33D1 (n= 0, 16)
    00000 ( 00000 )
    25.00 ( 31.03 )
        Dyspnea: C34D1 (n= 0, 14)
    00000 ( 00000 )
    26.19 ( 26.73 )
        Dyspnea: C35D1 (n= 0, 12)
    00000 ( 00000 )
    25.00 ( 25.13 )
        Dyspnea: C36D1 (n= 0, 8)
    00000 ( 00000 )
    20.83 ( 17.25 )
        Dyspnea: C37D1 (n= 0, 5)
    00000 ( 00000 )
    26.67 ( 14.91 )
        Dyspnea: C38D1 (n= 0, 2)
    00000 ( 00000 )
    33.33 ( 0.00 )
        Dyspnea: EOT(n= 266, 247)
    38.72 ( 30.51 )
    39.41 ( 32.57 )
        Dyspnea: Pro Week 6 Pd (n= 0, 1)
    00000 ( 00000 )
    33.33 ( 99999 )
        Dyspnea: Survival Follow-Up 1 (n= 2, 1)
    33.33 ( 47.14 )
    33.33 ( 99999 )
        Insomnia: EOT(n= 264, 246)
    28.91 ( 30.65 )
    29.95 ( 30.30 )
    No statistical analyses for this end point

    Secondary: EORTC QLQ-C30 Questionnaire Score: Functional Subscales

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    End point title
    		 EORTC QLQ-C30 Questionnaire Score: Functional Subscales
    End point description
    EORTC QLQ-C30 included GHS/QOL, Fx scales (physical, role, cognitive, emotional, social), Sx scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions on 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were 7-point scale (1/Very Poor to 7/Excellent). For instrument, GHS/QOL and Fx scales linearly transformed so each score 0-100; lower scores=poorer Fx (worsening), higher scores=better Fx (improvement). Sx scales/items also linearly transformed so each score 0-100; higher scores=worse Sx (more severe/worsened), lower scores=less Sx (less severe/improvement). PP-ITT analysis set. ’n’=subjects evaluated at specific timepoint for each group. '99999'=SD non-estimable due to 1 participant evaluated. '00000'=data not reported due to no participant evaluated.
    End point type
    Secondary
    End point timeframe
    Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Cognitive: Baseline (n= 390, 411)
    83.38 ( 20.68 )
    85.16 ( 19.16 )
        Cognitive: C2D1(n= 341, 363)
    83.38 ( 21.64 )
    84.94 ( 19.30 )
        Cognitive: C3D1(n= 256, 305)
    84.05 ( 19.82 )
    86.28 ( 17.32 )
        Cognitive: C4D1(n= 224, 281)
    84.82 ( 19.27 )
    85.35 ( 19.87 )
        Cognitive: C5D1(n= 166, 238)
    86.04 ( 17.24 )
    84.38 ( 19.73 )
        Cognitive: C6D1(n= 151, 224)
    86.09 ( 18.20 )
    84.45 ( 20.27 )
        Cognitive: C7D1(n= 87, 189)
    87.55 ( 16.32 )
    84.74 ( 18.93 )
        Cognitive: C8D1(n= 72, 171)
    89.58 ( 13.83 )
    85.58 ( 18.87 )
        Cognitive: C9D1(n= 50, 153)
    90.00 ( 14.29 )
    85.95 ( 18.65 )
        Cognitive: C10D1(n= 47, 146)
    91.13 ( 11.96 )
    86.53 ( 19.31 )
        Cognitive: C11D1(n= 36, 134)
    92.59 ( 10.87 )
    85.95 ( 19.91 )
        Cognitive: C12D1(n= 30, 132)
    91.11 ( 12.17 )
    84.22 ( 20.52 )
        Cognitive: C13D1(n= 18, 124)
    90.74 ( 11.75 )
    84.27 ( 21.50 )
        Cognitive: C14D1(n= 17, 121)
    92.16 ( 11.96 )
    85.67 ( 18.30 )
        Cognitive: C15D1(n= 15, 113)
    93.33 ( 10.54 )
    85.10 ( 19.08 )
        Cognitive: C16D1(n= 12, 109)
    97.22 ( 6.49 )
    85.32 ( 21.12 )
        Cognitive: C17D1(n= 11, 98)
    96.97 ( 6.74 )
    85.37 ( 20.48 )
        Cognitive: C18D1(n= 10, 92)
    91.67 ( 11.79 )
    82.97 ( 20.52 )
        Cognitive: C19D1(n= 9, 84)
    92.59 ( 12.11 )
    83.53 ( 20.12 )
        Cognitive: C20D1(n= 9, 80)
    90.74 ( 14.70 )
    82.29 ( 22.87 )
        Cognitive: C21D1(n= 9, 75)
    87.04 ( 23.24 )
    83.78 ( 20.32 )
        Cognitive: C22D1(n= 8, 68)
    89.58 ( 12.40 )
    84.56 ( 21.03 )
        Cognitive: C23D1(n= 8, 66)
    95.83 ( 7.72 )
    84.09 ( 20.55 )
        Cognitive: C24D1(n= 5, 64)
    83.33 ( 23.57 )
    83.85 ( 23.56 )
        Cognitive: C25D1(n= 3, 60)
    72.22 ( 25.46 )
    83.61 ( 21.59 )
        Cognitive: C26D1(n= 3, 55)
    77.78 ( 19.24 )
    82.73 ( 21.51 )
        Cognitive: C27D1(n= 3, 52)
    88.89 ( 19.24 )
    85.26 ( 20.25 )
        Cognitive: C28D1(n= 1, 48)
    100.00 ( 99999 )
    85.07 ( 20.98 )
        Cognitive: C29D1(n= 2, 40)
    50.00 ( 70.71 )
    83.75 ( 20.84 )
        Cognitive: C30D1(n= 1, 31)
    100.00 ( 99999 )
    86.02 ( 20.68 )
        Cognitive: C31D1(n= 0, 24)
    00000 ( 00000 )
    80.56 ( 21.23 )
        Cognitive: C32D1(n= 0, 22)
    00000 ( 00000 )
    82.58 ( 22.11 )
        Cognitive: C33D1(n= 0,16)
    00000 ( 00000 )
    77.08 ( 25.73 )
        Cognitive: C34D1(n= 0, 14)
    00000 ( 00000 )
    80.95 ( 24.33 )
        Cognitive: C35D1(n= 0, 12)
    00000 ( 00000 )
    76.39 ( 21.86 )
        Cognitive: C36D1(n= 0, 8)
    00000 ( 00000 )
    83.33 ( 15.43 )
        Cognitive: C37D1(n= 0, 5)
    00000 ( 00000 )
    83.33 ( 16.67 )
        Cognitive: C38D1(n= 0, 2)
    00000 ( 00000 )
    91.67 ( 11.79 )
        Cognitive: EOT(n= 265, 246)
    78.82 ( 24.54 )
    78.52 ( 22.50 )
        Cognitive: Pro Week 6 Pd(n= 0,1)
    00000 ( 00000 )
    83.33 ( 99999 )
        Cognitive: Survival FU 1 (n= 2, 1)
    50.00 ( 47.14 )
    0.00 ( 99999 )
        Emotional: Baseline (n= 390, 411)
    75.83 ( 22.59 )
    76.55 ( 21.77 )
        Emotional: C2D1(n= 341, 363)
    78.06 ( 22.63 )
    79.47 ( 20.72 )
        Emotional: C3D1(n= 256, 305)
    79.70 ( 22.24 )
    82.71 ( 17.45 )
        Emotional: C4D1(n= 224, 280)
    81.67 ( 20.36 )
    83.69 ( 17.70 )
        Emotional: C5D1(n= 166, 238)
    80.52 ( 20.24 )
    81.99 ( 19.22 )
        Emotional: C6D1(n= 151, 224)
    81.73 ( 20.50 )
    82.70 ( 19.91 )
        Emotional: C7D1(n= 87, 189)
    81.42 ( 22.00 )
    83.77 ( 17.71 )
        Emotional: C8D1(n= 72, 171)
    84.38 ( 18.66 )
    83.63 ( 19.40 )
        Emotional: C9D1(n= 50, 153)
    86.00 ( 17.93 )
    85.62 ( 18.72 )
        Emotional: C10D1(n= 47, 146)
    84.93 ( 17.69 )
    84.13 ( 19.74 )
        Emotional: C11D1(n= 36, 134)
    89.12 ( 15.15 )
    84.16 ( 18.14 )
        Emotional: C12D1(n= 30, 132)
    86.94 ( 14.79 )
    84.34 ( 20.10 )
        Emotional: C13D1(n= 18, 123)
    89.35 ( 14.52 )
    84.35 ( 19.75 )
        Emotional: C14D1(n= 17, 121)
    86.27 ( 15.57 )
    84.25 ( 19.11 )
        Emotional: C15D1(n= 15, 113)
    90.00 ( 14.16 )
    83.87 ( 20.04 )
        Emotional: C16D1(n= 12, 109)
    88.89 ( 16.02 )
    82.11 ( 22.59 )
        Emotional: C17D1(n= 11, 98)
    88.64 ( 17.59 )
    83.25 ( 19.50 )
        Emotional: C18D1(n= 10, 92)
    87.50 ( 19.35 )
    82.52 ( 21.11 )
        Emotional: C19D1(n= 9, 84)
    87.96 ( 19.14 )
    81.42 ( 20.55 )
        Emotional: C20D1(n=9, 80)
    76.85 ( 34.30 )
    83.19 ( 18.90 )
        Emotional: C21D1(n= 9, 75)
    83.33 ( 26.68 )
    84.19 ( 17.58 )
        Emotional: C22D1(n= 8, 68)
    76.74 ( 32.60 )
    86.03 ( 16.44 )
        Emotional: C23D1(n= 8, 66)
    89.58 ( 15.91 )
    87.00 ( 17.55 )
        Emotional: C24D1(n=5, 65)
    78.33 ( 33.12 )
    83.72 ( 19.18 )
        Emotional: C25D1(n= 3, 60)
    100.00 ( 0.00 )
    83.66 ( 18.77 )
        Emotional: C26D1(n= 3, 55)
    86.11 ( 12.73 )
    85.15 ( 19.69 )
        Emotional: C27D1(n= 3, 52)
    100.00 ( 0.00 )
    86.38 ( 18.38 )
        Emotional: C28D1(n= 1, 48)
    100.00 ( 99999 )
    86.92 ( 17.51 )
        Emotional: C29D1(n= 2, 40)
    50.00 ( 70.71 )
    87.50 ( 16.45 )
        Emotional: C30D1(n= 1, 31)
    100.00 ( 99999 )
    89.79 ( 15.62 )
        Emotional: C31D1(n= 0, 24)
    00000 ( 00000 )
    85.76 ( 18.30 )
        Emotional: C32D1(n= 0, 22)
    00000 ( 00000 )
    82.95 ( 20.81 )
        Emotional: C33D1(n= 0, 16)
    00000 ( 00000 )
    81.25 ( 25.37 )
        Emotional: C34D1(n= 0, 14)
    00000 ( 00000 )
    82.14 ( 25.29 )
        Emotional: C35D1(n= 0, 12)
    00000 ( 00000 )
    83.33 ( 21.61 )
        Emotional: C36D1(n= 0, 8)
    00000 ( 00000 )
    95.83 ( 11.78 )
        Emotional: C37D1(n= 0, 5)
    00000 ( 00000 )
    90.00 ( 14.91 )
        Emotional: C38D1(n= 0, 2)
    00000 ( 00000 )
    83.33 ( 23.57 )
        Emotional: EOT (n= 265, 246)
    73.78 ( 26.29 )
    73.92 ( 23.74 )
        Emotional: Pro Week 6 Pd(n= 0,1)
    00000 ( 00000 )
    66.67 ( 99999 )
        Emotional: Survival FU-1 (n= 2,1)
    25.00 ( 35.36 )
    33.33 ( 99999 )
        Physical: Baseline (n= 390, 413)
    73.27 ( 22.58 )
    74.46 ( 20.66 )
        Physical: C2D1(n= 343, 369)
    72.64 ( 22.00 )
    71.70 ( 22.49 )
        Physical: C3D1(n= 255, 304)
    74.98 ( 21.60 )
    76.19 ( 19.48 )
        Physical: C4D1(n= 224, 277)
    75.72 ( 19.05 )
    76.79 ( 19.95 )
        Physical: C5D1(n= 167, 238)
    77.30 ( 19.00 )
    77.79 ( 19.89 )
        Physical: C6D1(n= 151, 225)
    74.77 ( 19.26 )
    78.93 ( 18.76 )
        Physical: C7D1(n= 88, 189)
    77.61 ( 18.08 )
    79.20 ( 18.42 )
        Physical: C8D1(n= 71, 170)
    78.45 ( 17.72 )
    78.87 ( 18.91 )
        Physical: C9D1(n= 50, 153)
    79.07 ( 20.43 )
    79.46 ( 18.75 )
        Physical: C10D1(n= 47, 146)
    79.29 ( 19.96 )
    79.41 ( 18.85 )
        Physical: C11D1(n= 37, 134)
    81.44 ( 20.85 )
    79.09 ( 20.50 )
        Physical: C12D1(n= 30, 132)
    82.22 ( 15.69 )
    79.72 ( 18.84 )
        Physical: C13D1(n= 19, 124)
    87.37 ( 9.66 )
    80.48 ( 19.33 )
        Physical: C14D1(n= 18, 121)
    85.56 ( 9.50 )
    80.33 ( 17.55 )
        Physical: C15D1(n= 16, 113)
    86.25 ( 8.24 )
    79.88 ( 18.64 )
        Physical: C16D1(n= 13, 109)
    85.13 ( 9.49 )
    78.82 ( 21.32 )
        Physical: C17D1(n= 11, 98)
    84.24 ( 12.03 )
    78.57 ( 20.89 )
        Physical: C18D1(n= 10, 92)
    82.67 ( 13.03 )
    79.64 ( 19.92 )
        Physical: C19D1(n= 9, 84)
    87.41 ( 10.77 )
    78.97 ( 20.48 )
        Physical: C20D1(n= 9, 80)
    81.48 ( 18.19 )
    79.19 ( 20.26 )
        Physical: C21D1(n= 9, 75)
    87.41 ( 11.28 )
    78.67 ( 20.68 )
        Physical: C22D1(n= 8, 69)
    82.50 ( 19.82 )
    82.51 ( 16.92 )
        Physical: C23D1(n= 8, 66)
    85.00 ( 13.21 )
    80.81 ( 17.56 )
        Physical: C24D1(n= 5, 64)
    80.00 ( 18.26 )
    81.41 ( 17.69 )
        Physical: C25D1(n= 3, 60)
    82.22 ( 16.78 )
    83.22 ( 16.67 )
        Physical: C26D1(n= 3, 55)
    75.56 ( 3.85 )
    80.12 ( 17.43 )
        Physical: C27D1(n= 2, 52)
    76.67 ( 4.71 )
    81.89 ( 16.90 )
        Physical: C28D1(n= 2, 49)
    65.00 ( 21.21 )
    84.15 ( 14.41 )
        Physical: C29D1(n= 2, 40)
    56.67 ( 33.00 )
    83.00 ( 14.87 )
        Physical: C30D1(n= 1, 31)
    80.00 ( 99999 )
    83.01 ( 15.67 )
        Physical: C31D1(n= 0, 24)
    00000 ( 00000 )
    78.61 ( 17.25 )
        Physical: C32D1(n= 0, 22)
    00000 ( 00000 )
    75.15 ( 18.42 )
        Physical: C33D1(n= 0, 16)
    00000 ( 00000 )
    77.92 ( 17.84 )
        Physical: C34D1(n= 0, 14)
    00000 ( 00000 )
    75.24 ( 19.47 )
        Physical: C35D1(n= 0, 12)
    00000 ( 00000 )
    73.89 ( 20.78 )
        Physical: C36D1(n= 0, 8)
    00000 ( 00000 )
    83.33 ( 17.46 )
        Physical: C37D1(n= 0, 5)
    00000 ( 00000 )
    74.67 ( 14.45 )
        Physical: C38D1(n= 0, 2)
    00000 ( 00000 )
    86.67 ( 0.00 )
        Physical: EOT(n= 267, 246)
    63.59 ( 24.57 )
    64.78 ( 26.47 )
        Physical: Pro Week 6 Pd(n= 0, 1)
    00000 ( 00000 )
    46.67 ( 99999 )
        Physical: Survival FU-1 (n= 2, 1)
    36.67 ( 51.85 )
    46.67 ( 99999 )
        Role: Baseline (n=388, 413)
    70.92 ( 30.68 )
    73.61 ( 29.13 )
        Role: C2D1 (n=339, 369)
    69.91 ( 29.89 )
    68.29 ( 31.50 )
        Role: C3D1 (n=256, 304)
    74.61 ( 27.21 )
    75.27 ( 27.28 )
        Role: C4D1 (n=224, 279)
    73.36 ( 26.22 )
    76.70 ( 25.27 )
        Role: C5D1 (n=167, 238)
    74.35 ( 25.00 )
    76.05 ( 26.97 )
        Role: C6D1 (n=151, 225)
    73.62 ( 26.62 )
    77.70 ( 26.78 )
        Role: C7D1 (n=88, 190)
    77.27 ( 23.19 )
    79.04 ( 24.97 )
        Role: C8D1 (n=72, 170)
    73.61 ( 26.50 )
    77.35 ( 25.22 )
        Role: C9D1 (n=50, 153)
    77.67 ( 24.42 )
    79.30 ( 25.36 )
        Role: C10D1 (n=47, 145)
    78.72 ( 27.74 )
    81.38 ( 24.34 )
        Role: C11D1 (n=37, 134)
    80.63 ( 24.69 )
    78.61 ( 27.01 )
        Role: C12D1 (n=30, 132)
    81.11 ( 22.20 )
    79.80 ( 25.97 )
        Role: C13D1 (n=19, 124)
    84.21 ( 18.82 )
    79.44 ( 26.55 )
        Role: C14D1 (n=18, 121)
    78.70 ( 21.24 )
    79.48 ( 24.98 )
        Role: C15D1 (n=16, 113)
    83.33 ( 14.91 )
    79.20 ( 25.05 )
        Role: C16D1 (n=13, 109)
    85.90 ( 19.06 )
    76.45 ( 27.89 )
        Role: C17D1 (n=11, 98)
    80.30 ( 20.84 )
    76.02 ( 29.22 )
        Role: C18D1 (n=10, 92)
    80.00 ( 26.99 )
    77.17 ( 27.59 )
        Role: C19D1 (n=9, 84)
    85.19 ( 22.74 )
    78.17 ( 28.46 )
        Role: C20D1 (n=9, 80)
    79.63 ( 29.79 )
    78.54 ( 26.01 )
        Role: C21D1 (n=9, 75)
    85.19 ( 15.47 )
    77.33 ( 28.29 )
        Role: C22D1 (n=8, 69)
    79.17 ( 35.36 )
    81.64 ( 26.68 )
        Role: C23D1 (n=8, 66)
    85.42 ( 20.77 )
    80.30 ( 26.13 )
        Role: C24D1 (n=5, 65)
    70.00 ( 34.16 )
    78.72 ( 26.92 )
        Role: C25D1 (n=3, 60)
    77.78 ( 38.49 )
    79.44 ( 27.34 )
        Role: C26D1 (n=3, 55)
    83.33 ( 28.87 )
    76.97 ( 27.31 )
        Role: C27D1 (n=3, 52)
    88.89 ( 19.24 )
    80.77 ( 26.89 )
        Role: C28D1 (n=1, 49)
    100.00 ( 99999 )
    82.99 ( 22.69 )
        Role: C29D1 (n=2, 40)
    66.67 ( 47.14 )
    83.33 ( 24.75 )
        Role: C30D1 (n=1, 31)
    100.00 ( 99999 )
    81.72 ( 24.10 )
        Role: C31D1(n=0, 24)
    00000 ( 00000 )
    79.86 ( 25.53 )
        Role: C32D1(n=0, 22)
    00000 ( 00000 )
    75.00 ( 27.58 )
        Role: C33D1(n=0, 16)
    00000 ( 00000 )
    66.67 ( 34.43 )
        Role: C34D1(n=0, 14)
    00000 ( 00000 )
    69.05 ( 33.88 )
        Role: C35D1(n=0, 12)
    00000 ( 00000 )
    69.44 ( 32.44 )
        Role: C36D1(n=0, 8)
    00000 ( 00000 )
    87.50 ( 17.25 )
        Role: C37D1(n=0, 5)
    00000 ( 00000 )
    76.67 ( 22.36 )
        Role: C38D1(n=0, 2)
    00000 ( 00000 )
    100.00 ( 0.00 )
        Role: EOT(n=266, 246)
    58.52 ( 32.99 )
    60.03 ( 33.25 )
        Role: Pro Week 6 Pd (n=0, 1)
    00000 ( 00000 )
    66.67 ( 99999 )
        Role: Survival FU-1 (n=2,1)
    33.33 ( 47.14 )
    33.33 ( 99999 )
        Social: Baseline (n= 389, 411)
    74.16 ( 26.92 )
    77.41 ( 26.13 )
        Social: C2D1(n= 340, 363)
    74.51 ( 26.50 )
    76.86 ( 26.25 )
        Social: C3D1(n= 255, 305)
    78.37 ( 25.30 )
    81.15 ( 23.70 )
        Social: C4D1(n= 223, 280)
    79.60 ( 23.00 )
    81.31 ( 24.15 )
        Social: C5D1(n= 166, 238)
    79.32 ( 22.26 )
    82.00 ( 24.39 )
        Social: C6D1(n= 151, 224)
    78.15 ( 24.05 )
    81.99 ( 23.80 )
        Social: C7D1(n= 87, 189)
    80.65 ( 22.57 )
    82.80 ( 22.54 )
        Social: C8D1(n= 72, 171)
    81.94 ( 22.16 )
    81.19 ( 23.95 )
        Social: C9D1(n= 50, 153)
    82.00 ( 22.80 )
    83.77 ( 22.29 )
        Social: C10D1(n= 47, 146)
    81.21 ( 24.97 )
    83.79 ( 22.99 )
        Social: C11D1(n= 36, 134)
    82.41 ( 26.11 )
    81.47 ( 25.42 )
        Social: C12D1(n= 30, 132)
    86.67 ( 18.77 )
    82.95 ( 24.58 )
        Social: C13D1(n= 18, 124)
    89.81 ( 15.27 )
    84.27 ( 22.82 )
        Social: C14D1(n= 17, 121)
    86.27 ( 19.75 )
    84.16 ( 22.55 )
        Social: C15D1(n= 15, 113)
    93.33 ( 13.80 )
    83.92 ( 22.26 )
        Social: C16D1(n= 12, 109)
    84.72 ( 16.60 )
    82.72 ( 24.73 )
        Social: C17D1(n= 11, 98)
    87.88 ( 16.82 )
    82.99 ( 23.57 )
        Social: C18D1(n= 10, 92)
    86.67 ( 17.21 )
    81.34 ( 24.06 )
        Social: C19D1(n= 9, 84)
    88.89 ( 16.67 )
    81.94 ( 25.90 )
        Social: C20D1(n= 9, 80)
    81.48 ( 33.79 )
    81.46 ( 24.73 )
        Social: C21D1(n= 9, 75)
    85.19 ( 24.22 )
    78.67 ( 27.88 )
        Social: C22D1(n= 8, 68)
    85.42 ( 30.13 )
    84.31 ( 25.41 )
        Social: C23D1(n= 8, 66)
    91.67 ( 15.43 )
    80.56 ( 26.24 )
        Social: C24D1(n= 5, 65)
    80.00 ( 27.39 )
    80.77 ( 25.38 )
        Social: C25D1(n= 3, 60)
    77.78 ( 38.49 )
    81.39 ( 27.80 )
        Social: C26D1(n= 3, 55)
    77.78 ( 19.24 )
    79.70 ( 27.53 )
        Social: C27D1(n= 3, 52)
    88.89 ( 19.24 )
    82.05 ( 25.32 )
        Social: C28D1(n= 1, 48)
    100.00 ( 99999 )
    84.03 ( 24.30 )
        Social: C29D1(n= 2, 40)
    50.00 ( 70.71 )
    82.92 ( 24.60 )
        Social: C30D1(n= 1, 31)
    100.00 ( 99999 )
    79.57 ( 27.79 )
        Social: C31D1(n= 0, 24)
    00000 ( 00000 )
    79.17 ( 26.12 )
        Social: C32D1(n= 0, 22)
    00000 ( 00000 )
    73.48 ( 30.71 )
        Social: C33D1(n= 0, 16)
    00000 ( 00000 )
    73.96 ( 32.19 )
        Social: C34D1(n= 0, 14)
    00000 ( 00000 )
    67.86 ( 34.88 )
        Social: C35D1(n= 0, 12)
    00000 ( 00000 )
    70.83 ( 31.88 )
        Social: C36D1(n= 0, 8)
    00000 ( 00000 )
    87.50 ( 17.25 )
        Social: C37D1(n= 0, 5)
    00000 ( 00000 )
    80.00 ( 18.26 )
        Social: C38D1(n= 0, 2)
    00000 ( 00000 )
    100.00 ( 0.00 )
        Social: EOT(n= 264, 245)
    69.51 ( 30.65 )
    70.00 ( 30.05 )
        Social: Pro Week Pd(n= 0, 1)
    00000 ( 00000 )
    66.67 ( 99999 )
        Social: Survival FU-1 (n= 2, 1)
    83.33 ( 23.57 )
    16.67 ( 99999 )
    No statistical analyses for this end point

    Secondary: EORTC QLQ-C30 Questionnaire Score: GHS Scale

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    End point title
    		 EORTC QLQ-C30 Questionnaire Score: GHS Scale
    End point description
    EORTC QLQ-C30 included GHS/QOL, Fx scales (physical, role, cognitive, emotional, social), Sx scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions on 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were 7-point scale (1/Very Poor to 7/Excellent). For instrument, GHS/QOL and Fx scales linearly transformed so each score 0-100; lower scores=poorer Fx (worsening), higher scores=better Fx (improvement). Sx scales/items also linearly transformed so each score 0-100; higher scores=worse Sx (more severe/worsened), lower scores=less Sx (less severe/improvement). PP-ITT analysis set. ’n’=subjects evaluated at specific timepoint for each group. '99999'=SD non-estimable due to 1 participant evaluated. '00000'=data not reported due to no participant evaluated.
    End point type
    Secondary
    End point timeframe
    Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Global Health: Baseline (n= 387, 410)
    60.55 ( 22.25 )
    61.24 ( 22.31 )
        Global Health: C2D1(n= 339, 361)
    59.56 ( 22.15 )
    58.93 ( 23.57 )
        Global Health: C3D1(n= 255, 304)
    64.64 ( 18.66 )
    64.61 ( 20.74 )
        Global Health: C4D1(n= 222, 279)
    63.51 ( 20.67 )
    65.11 ( 21.36 )
        Global Health: C5D1(n= 166, 235)
    64.01 ( 18.37 )
    66.35 ( 19.84 )
        Global Health: C6D1(n= 151, 223)
    64.51 ( 19.59 )
    65.73 ( 21.42 )
        Global Health: C7D1(n= 87, 187)
    64.85 ( 18.13 )
    66.93 ( 19.61 )
        Global Health: C8D1(n= 72, 169)
    62.73 ( 20.22 )
    67.36 ( 19.45 )
        Global Health: C9D1(n= 50, 152)
    67.17 ( 18.93 )
    68.09 ( 19.46 )
        Global Health: C10D1(n= 47, 145)
    66.84 ( 18.67 )
    69.37 ( 20.90 )
        Global Health: C11D1(n= 36, 133)
    69.68 ( 17.15 )
    68.17 ( 21.24 )
        Global Health: C12D1(n= 30, 131)
    66.67 ( 18.05 )
    68.32 ( 20.42 )
        Global Health: C13D1(n= 18, 124)
    69.91 ( 14.33 )
    67.74 ( 22.52 )
        Global Health: C14D1(n= 17, 120)
    69.61 ( 14.71 )
    67.01 ( 20.62 )
        Global Health: C15D1(n= 15, 113)
    69.44 ( 17.16 )
    68.66 ( 20.21 )
        Global Health: C16D1(n= 12, 109)
    62.50 ( 15.69 )
    67.97 ( 21.67 )
        Global Health: C17D1(n= 10, 98)
    61.67 ( 19.72 )
    68.62 ( 19.84 )
        Global Health: C18D1(n= 10, 92)
    61.67 ( 21.23 )
    68.57 ( 18.86 )
        Global Health: C19D1(n= 9, 84)
    65.74 ( 21.43 )
    68.25 ( 20.10 )
        Global Health: C20D1(n= 9, 80)
    62.04 ( 26.72 )
    68.12 ( 20.10 )
        Global Health: C21D1(n= 9, 75)
    60.19 ( 29.98 )
    66.56 ( 21.55 )
        Global Health: C22D1(n= 8, 68)
    54.17 ( 24.80 )
    73.28 ( 17.13 )
        Global Health: C23D1(n= 8, 66)
    62.50 ( 19.42 )
    70.45 ( 18.09 )
        Global Health: C24D1(n= 5, 65)
    70.00 ( 27.39 )
    69.36 ( 19.27 )
        Global Health: C25D1(n= 3, 60)
    66.67 ( 28.87 )
    69.03 ( 19.23 )
        Global Health: C26D1(n= 3, 55)
    66.67 ( 28.87 )
    68.64 ( 20.60 )
        Global Health: C27D1(n= 3, 52)
    66.67 ( 28.87 )
    68.91 ( 21.84 )
        Global Health: C28D1(n= 2, 48)
    87.50 ( 17.68 )
    71.87 ( 20.60 )
        Global Health: C29D1(n= 2, 40)
    91.67 ( 11.79 )
    72.71 ( 20.06 )
        Global Health: C30D1(n= 1, 30)
    83.33 ( 99999 )
    75.28 ( 18.63 )
        Global Health: C31D1(n= 0, 24)
    00000 ( 00000 )
    71.53 ( 21.13 )
        Global Health: C32D1(n= 0, 22)
    00000 ( 00000 )
    70.45 ( 20.21 )
        Global Health: C33D1(n= 0,16)
    00000 ( 00000 )
    67.19 ( 27.30 )
        Global Health: C34D1(n= 0, 14)
    00000 ( 00000 )
    68.45 ( 26.19 )
        Global Health: C35D1(n= 0, 12)
    00000 ( 00000 )
    69.44 ( 26.43 )
        Global Health: C36D1(n= 0, 8)
    00000 ( 00000 )
    80.21 ( 16.63 )
        Global Health: C37D1(n= 0, 5)
    00000 ( 00000 )
    76.67 ( 19.00 )
        Global Health: C38D1(n= 0, 2)
    00000 ( 00000 )
    91.67 ( 11.79 )
        Global Health: EOT(n= 262, 245)
    51.69 ( 24.02 )
    52.82 ( 24.48 )
        Global Health: Pro Week 6 Pd(n= 0,1)
    00000 ( 00000 )
    50.00 ( 99999 )
        Global Health: Survival FU 1 (n= 2, 1)
    58.33 ( 35.36 )
    33.33 ( 99999 )
    No statistical analyses for this end point

    Secondary: EORTC QLQ-C30 Questionnaire Score: Symptom Subscale

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    End point title
    		 EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
    End point description
    EORTC QLQ-C30 included GHS/QOL, Fx scales (physical, role, cognitive, emotional, social), Sx scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions on 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were 7-point scale (1/Very Poor to 7/Excellent). For instrument, GHS/QOL and Fx scales linearly transformed so each score 0-100; lower scores=poorer Fx (worsening), higher scores=better Fx (improvement). Sx scales/items also linearly transformed so each score 0-100; higher scores=worse Sx (more severe/worsened), lower scores=less Sx (less severe/improvement). PP-ITT analysis set. ’n’=subjects evaluated at specific timepoint for each group. '99999'=SD non-estimable due to 1 participant evaluated. '00000'=data not reported due to no participant evaluated.
    End point type
    Secondary
    End point timeframe
    Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Nausea/Vomiting: Baseline (n= 389, 413)
    8.01 ( 16.34 )
    7.59 ( 16.35 )
        Nausea/Vomiting: C2D1(n= 342, 369)
    11.50 ( 19.30 )
    9.53 ( 17.25 )
        Nausea/Vomiting: C3D1(n= 253, 305)
    7.05 ( 15.06 )
    7.27 ( 15.32 )
        Nausea/Vomiting: C4D1(n= 223, 279)
    7.40 ( 14.37 )
    7.17 ( 15.50 )
        Nausea/Vomiting: C5D1(n= 167, 238)
    6.29 ( 12.49 )
    6.44 ( 14.54 )
        Nausea/Vomiting: C6D1(n= 151, 225)
    6.40 ( 13.17 )
    6.44 ( 15.16 )
        Nausea/Vomiting: C7D1(n= 88, 190)
    6.82 ( 13.28 )
    5.61 ( 13.74 )
        Nausea/Vomiting: C8D1(n= 72, 170)
    6.02 ( 12.91 )
    4.61 ( 10.57 )
        Nausea/Vomiting: C9D1(n= 50, 153)
    3.33 ( 8.91 )
    2.83 ( 8.06 )
        Nausea/Vomiting: C10D1(n= 47, 146)
    2.48 ( 6.93 )
    3.54 ( 10.02 )
        Nausea/Vomiting: C11D1(n= 37, 134)
    3.15 ( 6.62 )
    3.23 ( 8.54 )
        Nausea/Vomiting: C12D1(n= 30, 132)
    3.89 ( 8.40 )
    3.03 ( 7.66 )
        Nausea/Vomiting: C13D1(n= 19, 124)
    4.39 ( 9.37 )
    3.36 ( 10.19 )
        Nausea/Vomiting: C14D1(n= 18, 121)
    4.63 ( 9.58 )
    3.31 ( 9.03 )
        Nausea/Vomiting: C15D1(n= 16, 113)
    1.04 ( 4.17 )
    3.83 ( 11.14 )
        Nausea/Vomiting: C16D1(n= 13, 109)
    5.13 ( 10.51 )
    2.75 ( 8.64 )
        Nausea/Vomiting: C17D1(n= 11, 98)
    9.09 ( 13.67 )
    2.55 ( 8.06 )
        Nausea/Vomiting: C18D1(n= 10, 92)
    6.67 ( 11.65 )
    3.08 ( 8.88 )
        Nausea/Vomiting: C19D1(n= 9, 84)
    3.70 ( 7.35 )
    4.17 ( 11.53 )
        Nausea/Vomiting: C20D1(n= 9, 80)
    5.56 ( 8.33 )
    3.13 ( 11.28 )
        Nausea/Vomiting: C21D1(n= 9, 75)
    1.85 ( 5.56 )
    4.89 ( 13.08 )
        Nausea/Vomiting: C22D1(n= 8, 69)
    6.25 ( 8.63 )
    1.93 ( 7.31 )
        Nausea/Vomiting: C23D1(n= 8, 66)
    6.25 ( 12.40 )
    2.53 ( 6.69 )
        Nausea/Vomiting: C24D1(n= 5, 64)
    0.00 ( 0.00 )
    2.34 ( 7.19 )
        Nausea/Vomiting: C25D1(n= 3, 60)
    0.00 ( 0.00 )
    1.94 ( 6.21 )
        Nausea/Vomiting: C26D1(n= 3, 55)
    0.00 ( 0.00 )
    2.73 ( 8.34 )
        Nausea/Vomiting: C27D1(n= 3, 52)
    0.00 ( 0.00 )
    2.24 ( 6.62 )
        Nausea/Vomiting: C28D1(n= 1, 49)
    0.00 ( 99999 )
    1.02 ( 4.04 )
        Nausea/Vomiting: C29D1(n= 2, 40)
    33.33 ( 47.14 )
    1.67 ( 5.06 )
        Nausea/Vomiting: C30D1(n= 1, 31)
    0.00 ( 99999 )
    1.61 ( 5.01 )
        Nausea/Vomiting: C31D1(n= 0, 24)
    00000 ( 00000 )
    2.08 ( 5.63 )
        Nausea/Vomiting: C32D1(n= 0, 22)
    00000 ( 00000 )
    1.52 ( 4.90 )
        Nausea/Vomiting: C33D1(n= 0,16)
    00000 ( 00000 )
    1.04 ( 4.17 )
        Nausea/Vomiting: C34D1(n= 0, 14)
    00000 ( 00000 )
    2.38 ( 8.91 )
        Nausea/Vomiting: C35D1(n= 0, 12)
    00000 ( 00000 )
    1.39 ( 4.81 )
        Nausea/Vomiting: C36D1(n= 0, 8)
    00000 ( 00000 )
    4.17 ( 11.78 )
        Nausea/Vomiting: C37D1(n= 0, 5)
    00000 ( 00000 )
    6.67 ( 9.13 )
        Nausea/Vomiting: C38D1(n= 0, 2)
    00000 ( 00000 )
    0.00 ( 0.00 )
        Nausea/Vomiting: EOT(n= 266, 245)
    11.65 ( 20.11 )
    10.61 ( 17.62 )
        Nausea/Vomiting: Pro Week 6 Pd(n= 0,1)
    00000 ( 00000 )
    16.67 ( 99999 )
        Nausea/Vomiting: Survival FU 1 (n= 2, 1)
    50.00 ( 70.71 )
    66.67 ( 99999 )
        Fatigue: Baseline (n= 390, 413)
    37.59 ( 25.69 )
    36.21 ( 23.92 )
        Fatigue: C2D1(n= 343, 369)
    40.52 ( 25.68 )
    39.78 ( 26.17 )
        Fatigue: C3D1(n= 256, 304)
    35.29 ( 23.97 )
    33.90 ( 23.75 )
        Fatigue: C4D1(n= 224, 278)
    35.59 ( 23.10 )
    30.72 ( 22.57 )
        Fatigue: C5D1(n= 167, 238)
    36.03 ( 22.40 )
    30.95 ( 24.13 )
        Fatigue: C6D1(n= 151, 225)
    36.28 ( 23.40 )
    28.89 ( 22.66 )
        Fatigue: C7D1(n= 88, 190)
    34.34 ( 23.02 )
    28.33 ( 22.15 )
        Fatigue: C8D1(n= 72, 170)
    30.86 ( 24.12 )
    27.97 ( 21.56 )
        Fatigue: C9D1(n= 50, 153)
    28.67 ( 23.45 )
    25.78 ( 21.39 )
        Fatigue: C10D1(n= 47, 145)
    29.31 ( 25.21 )
    26.32 ( 22.27 )
        Fatigue: C11D1(n= 37, 134)
    27.63 ( 25.07 )
    25.62 ( 23.05 )
        Fatigue: C12D1(n= 30, 132)
    28.89 ( 23.99 )
    26.60 ( 23.37 )
        Fatigue: C13D1(n= 19, 124)
    22.22 ( 20.29 )
    27.51 ( 22.73 )
        Fatigue: C14D1(n= 18, 121)
    21.60 ( 16.82 )
    26.31 ( 23.13 )
        Fatigue: C15D1(n= 16, 112)
    20.14 ( 18.24 )
    27.73 ( 22.56 )
        Fatigue: C16D1(n= 13, 109)
    21.79 ( 17.64 )
    27.22 ( 23.35 )
        Fatigue: C17D1(n= 11, 98)
    22.22 ( 12.17 )
    27.21 ( 23.56 )
        Fatigue: C18D1(n= 10, 92)
    26.67 ( 17.53 )
    27.29 ( 24.18 )
        Fatigue: C19D1(n= 9, 84)
    22.22 ( 14.70 )
    27.65 ( 22.85 )
        Fatigue: C20D1(n= 9, 80)
    32.10 ( 30.15 )
    25.21 ( 23.47 )
        Fatigue: C21D1(n= 9, 75)
    28.39 ( 18.52 )
    26.44 ( 23.66 )
        Fatigue: C22D1(n= 8, 69)
    33.33 ( 29.10 )
    22.38 ( 21.77 )
        Fatigue: C23D1(n= 8, 66)
    25.00 ( 24.31 )
    24.16 ( 20.59 )
        Fatigue: C24D1(n= 5, 64)
    31.11 ( 40.37 )
    23.78 ( 18.87 )
        Fatigue: C25D1(n= 3, 60)
    11.11 ( 19.24 )
    23.89 ( 20.94 )
        Fatigue: C26D1(n= 3, 55)
    18.52 ( 16.97 )
    28.69 ( 24.54 )
        Fatigue: C27D1(n= 3, 52)
    11.11 ( 19.24 )
    22.65 ( 19.80 )
        Fatigue: C28D1(n= 1, 49)
    0.00 ( 99999 )
    22.34 ( 18.23 )
        Fatigue: C29D1(n= 2, 40)
    44.44 ( 47.14 )
    21.11 ( 18.63 )
        Fatigue: C30D1(n= 1, 31)
    22.22 ( 99999 )
    23.66 ( 20.23 )
        Fatigue: C31D1(n= 0, 24)
    00000 ( 00000 )
    23.15 ( 20.96 )
        Fatigue: C32D1(n= 0, 22)
    00000 ( 00000 )
    25.25 ( 20.63 )
        Fatigue: C33D1(n= 0, 16)
    00000 ( 00000 )
    29.86 ( 26.52 )
        Fatigue: C34D1(n= 0, 14)
    00000 ( 00000 )
    31.75 ( 24.21 )
        Fatigue: C35D1(n= 0, 12)
    00000 ( 00000 )
    25.00 ( 21.25 )
        Fatigue: C36D1(n= 0, 8)
    00000 ( 00000 )
    16.67 ( 15.71 )
        Fatigue: C37D1(n= 0, 5)
    00000 ( 00000 )
    24.44 ( 16.48 )
        Fatigue: C38D1(n= 0, 2)
    00000 ( 00000 )
    16.67 ( 7.86 )
        Fatigue: EOT(n= 267, 246)
    47.50 ( 26.72 )
    43.07 ( 28.15 )
        Fatigue: Pro Week 6 Pd(n= 0, 1)
    00000 ( 00000 )
    44.44 ( 99999 )
        Fatigue: Survival FU-1 (n= 2, 1)
    83.33 ( 23.57 )
    88.89 ( 99999 )
        Pain: Baseline (n= 390, 413)
    29.70 ( 29.45 )
    29.98 ( 29.72 )
        Pain: C2D1(n= 343, 368)
    28.43 ( 27.24 )
    29.30 ( 29.03 )
        Pain: C3D1(n= 256, 305)
    22.59 ( 24.93 )
    24.15 ( 27.50 )
        Pain: C4D1(n= 224, 280)
    21.65 ( 24.48 )
    23.75 ( 25.84 )
        Pain: C5D1(n= 167, 239)
    20.96 ( 22.55 )
    23.22 ( 25.41 )
        Pain: C6D1(n= 151, 225)
    22.41 ( 21.95 )
    21.63 ( 24.68 )
        Pain: C7D1(n= 88, 190)
    21.59 ( 22.34 )
    21.58 ( 25.30 )
        Pain: C8D1(n= 72, 171)
    23.38 ( 22.49 )
    22.03 ( 24.36 )
        Pain: C9D1(n= 50, 153)
    16.33 ( 20.89 )
    19.28 ( 23.50 )
        Pain: C10D1(n= 47, 146)
    14.54 ( 17.93 )
    21.00 ( 24.61 )
        Pain: C11D1(n= 37, 134)
    13.96 ( 22.05 )
    21.27 ( 26.60 )
        Pain: C12D1(n= 30, 132)
    13.33 ( 21.17 )
    18.69 ( 24.71 )
        Pain: C13D1(n= 19, 124)
    16.67 ( 25.46 )
    17.74 ( 21.23 )
        Pain: C14D1(n= 18, 120)
    12.04 ( 15.97 )
    17.64 ( 22.17 )
        Pain: C15D1(n= 16, 113)
    10.42 ( 17.08 )
    17.40 ( 22.86 )
        Pain: C16D1(n= 13, 109)
    21.79 ( 21.93 )
    20.64 ( 25.25 )
        Pain: C17D1(n= 11, 98)
    16.67 ( 19.72 )
    20.41 ( 25.39 )
        Pain: C18D1(n= 10, 92)
    11.67 ( 22.29 )
    20.83 ( 24.54 )
        Pain: C19D1(n= 9, 84)
    14.81 ( 22.74 )
    22.42 ( 28.16 )
        Pain: C20D1(n=9, 80)
    27.78 ( 31.18 )
    20.00 ( 23.78 )
        Pain: C21D1(n= 9, 75)
    14.81 ( 17.57 )
    19.78 ( 25.95 )
        Pain: C22D1(n= 8, 69)
    18.75 ( 20.77 )
    15.22 ( 19.75 )
        Pain: C23D1(n= 8, 66)
    14.58 ( 27.37 )
    16.92 ( 23.11 )
        Pain: C24D1(n=5, 64)
    30.00 ( 36.13 )
    20.05 ( 25.05 )
        Pain: C25D1(n= 3, 60)
    16.67 ( 28.87 )
    18.33 ( 22.90 )
        Pain: C26D1(n= 3, 55)
    22.22 ( 19.24 )
    16.36 ( 21.87 )
        Pain: C27D1(n= 3, 52)
    11.11 ( 19.24 )
    15.06 ( 20.41 )
        Pain: C28D1(n= 1, 49)
    0.00 ( 99999 )
    14.29 ( 18.63 )
        Pain: C29D1(n= 2, 40)
    41.67 ( 58.93 )
    13.75 ( 18.06 )
        Pain: C30D1(n= 1, 31)
    0.00 ( 99999 )
    15.05 ( 21.24 )
        Pain: C31D1(n= 0, 24)
    00000 ( 00000 )
    14.58 ( 21.03 )
        Pain: C32D1(n= 0, 22)
    00000 ( 00000 )
    16.67 ( 24.67 )
        Pain: C33D1(n= 0, 16)
    00000 ( 00000 )
    20.83 ( 27.55 )
        Pain: C34D1(n= 0, 14)
    00000 ( 00000 )
    26.19 ( 27.51 )
        Pain: C35D1(n= 0, 12)
    00000 ( 00000 )
    22.22 ( 25.95 )
        Pain: C36D1(n= 0, 8)
    00000 ( 00000 )
    22.92 ( 34.43 )
        Pain: C37D1(n= 0, 5)
    00000 ( 00000 )
    30.00 ( 34.16 )
        Pain: C38D1(n= 0, 2)
    00000 ( 00000 )
    0.00 ( 0.00 )
        Pain: EOT (n= 267, 247)
    00000 ( 00000 )
    35.43 ( 31.22 )
        Pain: Pro Week 6 Pd(n= 0,1)
    32.21 ( 30.36 )
    16.67 ( 99999 )
        Pain: Survival FU-1 (n= 2,1)
    66.67 ( 47.14 )
    83.33 ( 99999 )
    No statistical analyses for this end point

    Secondary: EORTC QLQ-LC13 Questionnaire Score: Alopecia

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    End point title
    		 EORTC QLQ-LC13 Questionnaire Score: Alopecia
    End point description
    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 alopecia. The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. '99999' denotes data not reported because SD was non-estimable since only 1 participant was evaluated for this category. '00000' denotes data not reported because no participant was evaluated for this category.
    End point type
    Secondary
    End point timeframe
    Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Alopecia: Baseline (n= 384, 405)
    13.89 ( 27.95 )
    14.32 ( 29.07 )
        Alopecia: C2D1(n= 332, 357)
    60.44 ( 36.66 )
    6.63 ( 16.84 )
        Alopecia: C3D1(n= 248, 300)
    56.72 ( 35.86 )
    7.44 ( 18.89 )
        Alopecia: C4D1(n= 219, 270)
    52.36 ( 35.24 )
    7.41 ( 19.14 )
        Alopecia: C5D1(n= 163, 234)
    56.65 ( 37.25 )
    6.41 ( 16.68 )
        Alopecia: C6D1(n= 147, 220)
    54.42 ( 37.64 )
    7.88 ( 19.34 )
        Alopecia: C7D1(n= 87, 186)
    52.11 ( 39.28 )
    5.91 ( 16.10 )
        Alopecia: C8D1(n= 70, 166)
    48.57 ( 37.94 )
    6.63 ( 17.68 )
        Alopecia: C9D1(n= 47, 150)
    48.23 ( 39.81 )
    5.11 ( 14.83 )
        Alopecia: C10D1(n= 45, 142)
    49.63 ( 39.96 )
    3.76 ( 13.23 )
        Alopecia: C11D1(n= 36, 130)
    47.22 ( 45.34 )
    3.08 ( 11.33 )
        Alopecia: C12D1(n= 29, 129)
    36.78 ( 43.04 )
    4.91 ( 13.88 )
        Alopecia: C13D1(n= 19, 121)
    42.11 ( 41.34 )
    6.06 ( 15.52 )
        Alopecia: C14D1(n= 18, 119)
    29.63 ( 35.95 )
    5.60 ( 14.60 )
        Alopecia: C15D1(n= 16, 110)
    33.33 ( 34.43 )
    7.27 ( 17.12 )
        Alopecia: C16D1(n= 12, 105)
    27.78 ( 31.25 )
    7.30 ( 17.89 )
        Alopecia: C17D1(n= 11, 95)
    21.21 ( 30.81 )
    9.47 ( 19.85 )
        Alopecia: C18D1(n= 9, 90)
    22.22 ( 33.33 )
    8.89 ( 17.16 )
        Alopecia: C19D1(n= 8, 81)
    25.00 ( 34.50 )
    10.29 ( 18.74 )
        Alopecia: C20D1(n= 9, 78)
    44.44 ( 44.10 )
    8.55 ( 15.60 )
        Alopecia: C21D1(n= 9, 73)
    22.22 ( 33.33 )
    9.59 ( 16.18 )
        Alopecia: C22D1(n= 7, 67)
    9.52 ( 16.26 )
    9.45 ( 16.21 )
        Alopecia: C23D1(n= 8, 64)
    29.17 ( 37.53 )
    11.46 ( 18.99 )
        Alopecia: C24D1(n= 5, 62)
    13.33 ( 18.26 )
    8.06 ( 15.61 )
        Alopecia: C25D1(n= 2, 58)
    0.00 ( 0.00 )
    9.77 ( 16.53 )
        Alopecia: C26D1(n= 2, 53)
    0.00 ( 0.00 )
    9.43 ( 16.51 )
        Alopecia: C27D1(n= 3, 50)
    33.33 ( 57.74 )
    9.33 ( 16.55 )
        Alopecia: C28D1(n= 2, 46)
    0.00 ( 0.00 )
    6.52 ( 15.10 )
        Alopecia: C29D1(n= 2, 38)
    0.00 ( 0.00 )
    8.77 ( 20.04 )
        Alopecia: C30D1(n= 1, 31)
    0.00 ( 99999 )
    10.75 ( 19.98 )
        Alopecia: C31D1(n= 0, 24)
    00000 ( 00000 )
    9.72 ( 20.80 )
        Alopecia: C32D1(n= 0, 23)
    00000 ( 00000 )
    7.25 ( 19.99 )
        Alopecia: C33D1(n= 0,16)
    00000 ( 00000 )
    8.33 ( 22.77 )
        Alopecia: C34D1(n= 0, 14)
    00000 ( 00000 )
    9.52 ( 20.38 )
        Alopecia: C35D1(n= 0, 11)
    00000 ( 00000 )
    6.06 ( 13.48 )
        Alopecia: C36D1(n= 0, 8)
    00000 ( 00000 )
    4.17 ( 11.78 )
        Alopecia: C37D1(n= 0, 5)
    00000 ( 00000 )
    6.67 ( 14.91 )
        Alopecia: C38D1(n= 0, 2)
    00000 ( 00000 )
    0.00 ( 0.00 )
        Alopecia: EOT(n= 261, 243)
    53.51 ( 38.91 )
    6.58 ( 17.48 )
        Alopecia: Pro Week 6 Pd(n= 0,1)
    00000 ( 00000 )
    100.00 ( 99999 )
        Alopecia: Survival FU 1 (n= 2, 1)
    100.00 ( 0.00 )
    66.67 ( 99999 )
    No statistical analyses for this end point

    Secondary: EORTC QLQ-LC13 Questionnaire Score: Coughing

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    End point title
    		 EORTC QLQ-LC13 Questionnaire Score: Coughing
    End point description
    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 coughing. The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. '99999' denotes data not reported because SD was non-estimable since only 1 participant was evaluated for this category. '00000' denotes data not reported because no participant was evaluated for this category.
    End point type
    Secondary
    End point timeframe
    Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Coughing: Baseline (n= 383, 406)
    38.73 ( 29.64 )
    37.27 ( 27.23 )
        Coughing: C2D1(n= 333, 360)
    36.54 ( 28.04 )
    37.50 ( 28.33 )
        Coughing: C3D1(n= 250, 298)
    33.73 ( 27.46 )
    33.89 ( 24.99 )
        Coughing: C4D1(n= 219, 272)
    31.35 ( 24.13 )
    32.48 ( 25.52 )
        Coughing: C5D1(n= 164, 235)
    32.72 ( 23.49 )
    31.35 ( 25.52 )
        Coughing: C6D1(n= 147, 219)
    31.75 ( 24.78 )
    31.05 ( 24.73 )
        Coughing: C7D1(n= 87, 185)
    32.95 ( 24.64 )
    30.99 ( 25.07 )
        Coughing: C8D1(n= 69, 166)
    30.43 ( 28.43 )
    29.12 ( 25.73 )
        Coughing: C9D1(n= 50, 150)
    24.67 ( 17.57 )
    29.11 ( 24.52 )
        Coughing: C10D1(n= 47, 140)
    23.40 ( 19.55 )
    27.86 ( 22.83 )
        Coughing: C11D1(n= 37, 129)
    21.62 ( 19.59 )
    27.39 ( 23.37 )
        Coughing: C12D1(n= 30, 129)
    20.00 ( 18.77 )
    25.06 ( 23.95 )
        Coughing: C13D1(n= 19, 121)
    15.79 ( 17.10 )
    24.79 ( 23.78 )
        Coughing: C14D1(n= 18, 119)
    16.67 ( 17.15 )
    24.37 ( 22.42 )
        Coughing: C15D1(n= 16, 110)
    12.50 ( 16.67 )
    25.76 ( 23.31 )
        Coughing: C16D1(n= 13, 106)
    20.51 ( 21.68 )
    24.53 ( 22.21 )
        Coughing: C17D1(n= 11, 94)
    21.21 ( 16.82 )
    24.82 ( 23.92 )
        Coughing: C18D1(n= 10, 90)
    26.67 ( 21.08 )
    26.30 ( 24.22 )
        Coughing: C19D1(n= 9, 82)
    22.22 ( 16.67 )
    25.61 ( 26.86 )
        Coughing: C20D1(n= 9, 78)
    25.93 ( 14.70 )
    28.21 ( 26.36 )
        Coughing: C21D1(n= 9, 73)
    22.22 ( 16.67 )
    28.77 ( 27.95 )
        Coughing: C22D1(n= 8, 67)
    25.00 ( 38.83 )
    22.89 ( 23.36 )
        Coughing: C23D1(n= 8, 64)
    20.83 ( 17.25 )
    23.44 ( 26.35 )
        Coughing: C24D1(n= 5, 62)
    26.67 ( 14.91 )
    24.73 ( 23.33 )
        Coughing: C25D1(n= 3, 58)
    33.33 ( 0.00 )
    25.86 ( 23.40 )
        Coughing: C26D1(n= 3, 53)
    44.44 ( 19.25 )
    26.41 ( 24.77 )
        Coughing: C27D1(n= 3, 50)
    11.11 ( 19.24 )
    24.67 ( 22.14 )
        Coughing: C28D1(n= 2, 46)
    16.67 ( 23.57 )
    20.29 ( 20.46 )
        Coughing: C29D1(n= 2, 38)
    16.67 ( 23.57 )
    19.30 ( 22.77 )
        Coughing: C30D1(n= 1, 31)
    0.00 ( 99999 )
    18.28 ( 20.80 )
        Coughing: C31D1(n= 0, 24)
    00000 ( 00000 )
    23.61 ( 25.02 )
        Coughing: C32D1(n= 0, 23)
    00000 ( 00000 )
    26.09 ( 19.99 )
        Coughing: C33D1(n= 0,16)
    00000 ( 00000 )
    27.08 ( 32.70 )
        Coughing: C34D1(n= 0, 14)
    00000 ( 00000 )
    26.19 ( 29.75 )
        Coughing: C35D1(n= 0, 11)
    00000 ( 00000 )
    21.21 ( 22.47 )
        Coughing: C36D1(n= 0, 8)
    00000 ( 00000 )
    25.00 ( 15.43 )
        Coughing: C37D1(n= 0, 5)
    00000 ( 00000 )
    26.67 ( 14.91 )
        Coughing: C38D1(n= 0, 2)
    00000 ( 00000 )
    33.33 ( 0.00 )
        Coughing: EOT(n= 262, 246)
    35.75 ( 27.03 )
    38.48 ( 26.95 )
        Coughing: Pro Week 6 Pd(n= 0,1)
    00000 ( 00000 )
    33.33 ( 99999 )
        Coughing: Survival FU 1 (n= 2, 1)
    50.00 ( 23.57 )
    33.33 ( 99999 )
    No statistical analyses for this end point

    Secondary: EORTC QLQ-LC13 Questionnaire Score: Dysphagia

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    End point title
    		 EORTC QLQ-LC13 Questionnaire Score: Dysphagia
    End point description
    QLQ-LC13:13 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 dysphagia. The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. '99999' denotes data not reported because SD was non-estimable since only 1 participant was evaluated for this category. '00000' denotes data not reported because no participant was evaluated for this category.
    End point type
    Secondary
    End point timeframe
    Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Dysphagia: Baseline (n= 387, 406)
    6.20 ( 17.52 )
    5.09 ( 15.05 )
        Dysphagia: C2D1(n= 336, 358)
    10.22 ( 21.50 )
    6.42 ( 15.75 )
        Dysphagia: C3D1(n= 251, 301)
    9.16 ( 20.87 )
    5.43 ( 14.53 )
        Dysphagia: C4D1(n= 217, 272)
    8.60 ( 19.45 )
    5.88 ( 16.39 )
        Dysphagia: C5D1(n= 163, 236)
    6.75 ( 16.63 )
    6.64 ( 16.79 )
        Dysphagia: C6D1(n= 147, 219)
    6.80 ( 15.58 )
    4.72 ( 13.28 )
        Dysphagia: C7D1(n= 87, 187)
    4.21 ( 11.14 )
    5.70 ( 15.17 )
        Dysphagia: C8D1(n=70, 167)
    5.71 ( 12.65 )
    4.79 ( 12.82 )
        Dysphagia: C9D1(n= 50, 151)
    1.33 ( 6.60 )
    4.64 ( 14.42 )
        Dysphagia: C10D1(n= 47, 143)
    1.42 ( 6.80 )
    5.36 ( 15.14 )
        Dysphagia: C11D1(n= 37, 130)
    1.80 ( 7.64 )
    2.82 ( 11.01 )
        Dysphagia: C12D1(n= 29, 129)
    2.30 ( 8.60 )
    3.88 ( 12.93 )
        Dysphagia: C13D1(n= 19, 121)
    0.00 ( 0.00 )
    3.86 ( 11.54 )
        Dysphagia: C14D1(n= 18, 119)
    5.56 ( 12.78 )
    5.04 ( 13.47 )
        Dysphagia: C15D1(n= 16, 110)
    0.00 ( 0.00 )
    3.33 ( 11.01 )
        Dysphagia: C16D1(n= 13, 106)
    0.00 ( 0.00 )
    3.77 ( 12.45 )
        Dysphagia: C17D1(n= 11, 95)
    3.03 ( 10.05 )
    3.86 ( 13.63 )
        Dysphagia: C18D1(n= 10, 90)
    0.00 ( 0.00 )
    4.44 ( 15.96 )
        Dysphagia: C19D1(n= 9, 82)
    3.70 ( 11.11 )
    5.28 ( 15.24 )
        Dysphagia: C20D1(n= 9, 78)
    0.00 ( 0.00 )
    4.70 ( 12.85 )
        Dysphagia: C21D1(n= 9, 73)
    0.00 ( 0.00 )
    5.02 ( 15.39 )
        Dysphagia: C22D1(n= 8, 67)
    0.00 ( 0.00 )
    2.99 ( 11.21 )
        Dysphagia: C23D1(n= 8, 64)
    0.00 ( 0.00 )
    3.65 ( 12.05 )
        Dysphagia: C24D1(n= 5, 62)
    0.00 ( 0.00 )
    4.84 ( 15.79 )
        Dysphagia: C25D1(n= 3, 58)
    0.00 ( 0.00 )
    4.02 ( 15.39 )
        Dysphagia: C26D1(n= 3, 53)
    0.00 ( 0.00 )
    4.40 ( 13.14 )
        Dysphagia: C27D1(n= 3, 50)
    0.00 ( 0.00 )
    2.67 ( 11.35 )
        Dysphagia: C28D1(n= 2, 46)
    0.00 ( 0.00 )
    4.35 ( 15.09 )
        Dysphagia: C29D1(n= 2, 38)
    0.00 ( 0.00 )
    4.39 ( 13.80 )
        Dysphagia: C30D1(n= 1, 31)
    0.00 ( 99999 )
    5.38 ( 15.15 )
        Dysphagia: C31D1(n= 0, 24)
    00000 ( 00000 )
    5.56 ( 21.23 )
        Dysphagia: C32D1(n= 0, 23)
    00000 ( 00000 )
    7.25 ( 17.28 )
        Dysphagia: C33D1(n= 0,16)
    00000 ( 00000 )
    6.25 ( 13.44 )
        Dysphagia: C34D1(n= 0, 14)
    00000 ( 00000 )
    9.52 ( 20.38 )
        Dysphagia: C35D1(n= 0, 11)
    00000 ( 00000 )
    3.03 ( 10.05 )
        Dysphagia: C36D1(n= 0, 8)
    00000 ( 00000 )
    4.17 ( 11.78 )
        Dysphagia: C37D1(n= 0, 5)
    00000 ( 00000 )
    6.67 ( 14.91 )
        Dysphagia: C38D1(n= 0, 2)
    00000 ( 00000 )
    0.00 ( 0.00 )
        Dysphagia: EOT(n= 264, 245)
    10.23 ( 20.77 )
    8.98 ( 18.87 )
        Dysphagia: Pro Week 6 Pd(n= 0,1)
    00000 ( 00000 )
    0.00 ( 99999 )
        Dysphagia: Survival FU 1 (n= 2, 1)
    0.00 ( 0.00 )
    0.00 ( 99999 )
    No statistical analyses for this end point

    Secondary: EORTC QLQ-LC13 Questionnaire Score: Dyspnea

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    End point title
    		 EORTC QLQ-LC13 Questionnaire Score: Dyspnea
    End point description
    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 dyspnea. The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. '99999' denotes data not reported because SD was non-estimable since only 1 participant was evaluated for this category. '00000' denotes data not reported because no participant was evaluated for this category.
    End point type
    Secondary
    End point timeframe
    Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Dyspnea: Baseline (n= 386, 407)
    28.55 ( 23.21 )
    26.78 ( 22.43 )
        Dyspnea: C2D1(n= 335, 361)
    28.14 ( 23.48 )
    28.79 ( 23.67 )
        Dyspnea: C3D1(n= 252, 301)
    28.13 ( 22.45 )
    25.40 ( 20.60 )
        Dyspnea: C4D1(n= 220, 273)
    27.75 ( 19.85 )
    25.17 ( 21.14 )
        Dyspnea: C5D1(n= 165, 236)
    26.57 ( 19.61 )
    24.72 ( 19.90 )
        Dyspnea: C6D1(n= 148, 221)
    29.69 ( 21.94 )
    24.01 ( 21.09 )
        Dyspnea: C7D1(n= 87, 187)
    25.35 ( 21.07 )
    24.42 ( 21.23 )
        Dyspnea: C8D1(n=70, 167)
    28.02 ( 24.12 )
    24.42 ( 22.33 )
        Dyspnea: C9D1(n= 50, 151)
    26.00 ( 21.49 )
    22.44 ( 21.87 )
        Dyspnea: C10D1(n= 47, 143)
    27.42 ( 22.56 )
    22.18 ( 21.35 )
        Dyspnea: C11D1(n= 37, 130)
    22.67 ( 19.79 )
    20.43 ( 21.44 )
        Dyspnea: C12D1(n= 30, 129)
    22.41 ( 18.94 )
    22.27 ( 20.47 )
        Dyspnea: C13D1(n= 19, 121)
    16.37 ( 15.87 )
    22.22 ( 21.52 )
        Dyspnea: C14D1(n= 18, 119)
    17.90 ( 12.13 )
    22.41 ( 20.66 )
        Dyspnea: C15D1(n= 16, 110)
    15.28 ( 12.75 )
    22.12 ( 18.71 )
        Dyspnea: C16D1(n= 13, 106)
    14.53 ( 13.13 )
    21.91 ( 20.71 )
        Dyspnea: C17D1(n= 10, 95)
    18.89 ( 14.86 )
    23.51 ( 21.84 )
        Dyspnea: C18D1(n= 10, 90)
    20.00 ( 12.61 )
    22.65 ( 21.97 )
        Dyspnea: C19D1(n= 9, 82)
    18.52 ( 13.61 )
    22.09 ( 20.91 )
        Dyspnea: C20D1(n= 9, 78)
    20.37 ( 15.21 )
    22.65 ( 21.37 )
        Dyspnea: C21D1(n= 9, 73)
    19.75 ( 15.49 )
    20.40 ( 19.69 )
        Dyspnea: C22D1(n= 8, 67)
    18.06 ( 20.52 )
    19.90 ( 17.68 )
        Dyspnea: C23D1(n= 8, 64)
    16.67 ( 13.28 )
    21.2 ( 19.13 )
        Dyspnea: C24D1(n= 5, 62)
    20.00 ( 14.49 )
    21.33 ( 20.94 )
        Dyspnea: C25D1(n= 3, 58)
    29.63 ( 25.66 )
    19.73 ( 18.39 )
        Dyspnea: C26D1(n= 3, 53)
    22.22 ( 11.11 )
    21.80 ( 19.97 )
        Dyspnea: C27D1(n= 3, 50)
    18.52 ( 6.41 )
    20.33 ( 20.87 )
        Dyspnea: C28D1(n= 2, 46)
    5.56 ( 7.86 )
    18.36 ( 17.87 )
        Dyspnea: C29D1(n= 2, 38)
    5.56 ( 7.86 )
    19.30 ( 16.48 )
        Dyspnea: C30D1(n= 1, 31)
    11.11 ( 99999 )
    17.92 ( 17.14 )
        Dyspnea: C31D1(n= 0, 24)
    00000 ( 00000 )
    24.07 ( 18.73 )
        Dyspnea: C32D1(n= 0, 23)
    00000 ( 00000 )
    24.15 ( 20.00 )
        Dyspnea: C33D1(n= 0,16)
    00000 ( 00000 )
    25.69 ( 27.13 )
        Dyspnea: C34D1(n= 0, 14)
    00000 ( 00000 )
    27.78 ( 22.96 )
        Dyspnea: C35D1(n= 0, 11)
    00000 ( 00000 )
    26.26 ( 19.42 )
        Dyspnea: C36D1(n= 0, 8)
    00000 ( 00000 )
    18.06 ( 13.20 )
        Dyspnea: C37D1(n= 0, 5)
    00000 ( 00000 )
    24.44 ( 4.97 )
        Dyspnea: C38D1(n= 0, 2)
    00000 ( 00000 )
    16.67 ( 7.86 )
        Dyspnea: EOT(n= 263, 246)
    36.12 ( 24.82 )
    34.51 ( 26.36 )
        Dyspnea: Pro Week 6 Pd(n= 0,1)
    00000 ( 00000 )
    22.22 ( 99999 )
        Dyspnea: Survival FU 1 (n= 2, 1)
    66.67 ( 15.71 )
    44.44 ( 99999 )
    No statistical analyses for this end point

    Secondary: EORTC QLQ-LC13 Questionnaire Score: Hemoptysis

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    End point title
    		 EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
    End point description
    QLQ-LC13:13 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 hemoptysis. The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. '99999' denotes data not reported because SD was non-estimable since only 1 participant was evaluated for this category. '00000' denotes data not reported because no participant was evaluated for this category.
    End point type
    Secondary
    End point timeframe
    Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Hemoptysis: Baseline (n= 386, 406)
    4.32 ( 13.32 )
    3.86 ( 12.12 )
        Hemoptysis: C2D1(n= 336, 359)
    4.76 ( 14.24 )
    3.16 ( 10.97 )
        Hemoptysis: C3D1(n= 251, 301)
    4.38 ( 13.11 )
    3.10 ( 11.12 )
        Hemoptysis: C4D1(n= 220, 270)
    2.88 ( 10.89 )
    2.10 ( 9.94 )
        Hemoptysis: C5D1(n= 163, 234)
    1.43 ( 7.72 )
    1.42 ( 6.76 )
        Hemoptysis: C6D1(n= 148, 219)
    1.80 ( 7.56 )
    1.22 ( 6.27 )
        Hemoptysis: C7D1(n= 87, 187)
    1.15 ( 6.12 )
    1.43 ( 6.76 )
        Hemoptysis: C8D1(n=70, 166)
    1.90 ( 9.64 )
    2.41 ( 10.09 )
        Hemoptysis: C9D1(n= 50, 151)
    2.00 ( 8.00 )
    1.77 ( 7.49 )
        Hemoptysis: C10D1(n= 47, 143)
    2.84 ( 9.40 )
    0.70 ( 4.79 )
        Hemoptysis: C11D1(n= 37, 130)
    1.80 ( 7.64 )
    1.03 ( 5.78 )
        Hemoptysis: C12D1(n= 30, 129)
    0.00 ( 0.00 )
    1.03 ( 5.80 )
        Hemoptysis: C13D1(n= 19, 121)
    3.51 ( 10.51 )
    1.10 ( 5.98 )
        Hemoptysis: C14D1(n= 18, 119)
    1.85 ( 7.86 )
    1.68 ( 7.32 )
        Hemoptysis: C15D1(n= 16, 110)
    0.00 ( 0.00 )
    1.82 ( 10.91 )
        Hemoptysis: C16D1(n= 13, 106)
    0.00 ( 0.00 )
    2.83 ( 10.41 )
        Hemoptysis: C17D1(n= 11, 94)
    0.00 ( 0.00 )
    2.84 ( 12.61 )
        Hemoptysis: C18D1(n= 10, 90)
    0.00 ( 0.00 )
    2.96 ( 12.88 )
        Hemoptysis: C19D1(n= 9, 82)
    0.00 ( 0.00 )
    2.03 ( 12.11 )
        Hemoptysis: C20D1(n= 9, 78)
    0.00 ( 0.00 )
    2.56 ( 12.90 )
        Hemoptysis: C21D1(n= 8, 73)
    0.00 ( 0.00 )
    1.83 ( 7.64 )
        Hemoptysis: C22D1(n= 8, 67)
    0.00 ( 0.00 )
    1.99 ( 9.85 )
        Hemoptysis: C23D1(n= 8, 64)
    0.00 ( 0.00 )
    1.04 ( 5.85 )
        Hemoptysis: C24D1(n= 5, 61)
    0.00 ( 0.00 )
    2.73 ( 11.05 )
        Hemoptysis: C25D1(n= 3, 58)
    0.00 ( 0.00 )
    3.45 ( 13.52 )
        Hemoptysis: C26D1(n= 3, 53)
    0.00 ( 0.00 )
    3.77 ( 14.11 )
        Hemoptysis: C27D1(n= 3, 50)
    0.00 ( 0.00 )
    2.00 ( 8.00 )
        Hemoptysis: C28D1(n= 2, 46)
    33.33 ( 47.14 )
    1.45 ( 6.87 )
        Hemoptysis: C29D1(n= 2, 38)
    0.00 ( 0.00 )
    0.88 ( 5.41 )
        Hemoptysis: C30D1(n= 1, 31)
    0.00 ( 99999 )
    1.08 ( 5.99 )
        Hemoptysis: C31D1(n= 0, 24)
    00000 ( 00000 )
    2.78 ( 9.41 )
        Hemoptysis: C32D1(n= 0, 23)
    00000 ( 00000 )
    2.90 ( 9.60 )
        Hemoptysis: C33D1(n= 0,16)
    00000 ( 00000 )
    0.00 ( 0.00 )
        Hemoptysis: C34D1(n= 0, 14)
    00000 ( 00000 )
    0.00 ( 0.00 )
        Hemoptysis: C35D1(n= 0, 11)
    00000 ( 00000 )
    0.00 ( 0.00 )
        Hemoptysis: C36D1(n= 0, 8)
    00000 ( 00000 )
    4.17 ( 11.78 )
        Hemoptysis: C37D1(n= 0, 5)
    00000 ( 00000 )
    0.00 ( 0.00 )
        Hemoptysis: C38D1(n= 0, 2)
    00000 ( 00000 )
    0.00 ( 0.00 )
        Hemoptysis: EOT(n= 264, 243)
    5.18 ( 14.33 )
    6.04 ( 16.60 )
        Hemoptysis: Pro Week 6 Pd(n= 0,1)
    00000 ( 00000 )
    0.00 ( 99999 )
        Hemoptysis: Survival FU 1 (n= 2, 1)
    33.33 ( 47.14 )
    0.00 ( 99999 )
    No statistical analyses for this end point

    Secondary: EORTC QLQ-LC13 Questionnaire Score: Pain in Arm Or Shoulder

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    End point title
    		 EORTC QLQ-LC13 Questionnaire Score: Pain in Arm Or Shoulder
    End point description
    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 pain in arm or shoulder. The PP-ITT analysis set. 'n'=participants evaluated for this measure at specific time point for each group respectively. '99999' denotes data not reported because SD was non-estimable since only 1 participant was evaluated for this category. '00000' denotes data not reported because no participant was evaluated for this category.
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Pain in Arm or Shoulder: Baseline (n= 384, 405)
    20.49 ( 28.85 )
    20.16 ( 27.09 )
        Pain in Arm or Shoulder: C2D1(n= 332, 358)
    19.58 ( 27.45 )
    18.34 ( 26.56 )
        Pain in Arm or Shoulder: C3D1(n= 248, 294)
    17.20 ( 27.16 )
    16.44 ( 25.50 )
        Pain in Arm or Shoulder: C4D1(n= 217, 270)
    14.75 ( 23.74 )
    18.15 ( 26.57 )
        Pain in Arm or Shoulder: C5D1(n= 164, 232)
    16.06 ( 24.06 )
    14.94 ( 23.76 )
        Pain in Arm or Shoulder: C6D1(n= 147, 219)
    15.42 ( 23.17 )
    15.68 ( 24.37 )
        Pain in Arm or Shoulder: C7D1(n= 86, 184)
    14.73 ( 23.77 )
    16.67 ( 26.31 )
        Pain in Arm or Shoulder: C8D1(n=69, 163)
    15.94 ( 25.95 )
    16.77 ( 25.22 )
        Pain in Arm or Shoulder: C9D1(n= 50, 149)
    14.00 ( 24.36 )
    16.78 ( 25.89 )
        Pain in Arm or Shoulder: C10D1(n= 46, 141)
    14.49 ( 20.67 )
    17.73 ( 27.18 )
        Pain in Arm or Shoulder: C11D1(n= 36, 127)
    11.11 ( 19.52 )
    15.49 ( 26.82 )
        Pain in Arm or Shoulder: C12D1(n= 30, 126)
    12.22 ( 18.54 )
    16.93 ( 26.91 )
        Pain in Arm or Shoulder: C13D1(n= 19, 117)
    12.28 ( 19.91 )
    14.81 ( 22.93 )
        Pain in Arm or Shoulder: C14D1(n= 18, 117)
    11.11 ( 19.80 )
    15.67 ( 22.56 )
        Pain in Arm or Shoulder: C15D1(n= 16, 108)
    12.50 ( 20.64 )
    15.74 ( 24.31 )
        Pain in Arm or Shoulder: C16D1(n= 13, 104)
    7.69 ( 14.62 )
    14.10 ( 23.54 )
        Pain in Arm or Shoulder: C17D1(n= 11, 93)
    9.09 ( 15.57 )
    16.49 ( 25.83 )
        Pain in Arm or Shoulder: C18D1(n= 10, 88)
    13.33 ( 23.31 )
    18.18 ( 25.73 )
        Pain in Arm or Shoulder: C19D1(n= 9, 80)
    7.41 ( 14.70 )
    20.83 ( 29.23 )
        Pain in Arm or Shoulder: C20D1(n= 9, 76)
    11.11 ( 23.57 )
    18.42 ( 25.18 )
        Pain in Arm or Shoulder: C21D1(n= 9, 71)
    11.11 ( 16.67 )
    12.68 ( 19.81 )
        Pain in Arm or Shoulder: C22D1(n= 8, 65)
    16.67 ( 25.20 )
    13.33 ( 21.89 )
        Pain in Arm or Shoulder: C23D1(n= 8, 62)
    16.67 ( 25.20 )
    15.05 ( 22.32 )
        Pain in Arm or Shoulder: C24D1(n= 5, 59)
    20.00 ( 29.81 )
    18.08 ( 24.23 )
        Pain in Arm or Shoulder: C25D1(n= 3, 57)
    11.11 ( 19.24 )
    14.62 ( 21.84 )
        Pain in Arm or Shoulder: C26D1(n= 2, 52)
    16.67 ( 23.57 )
    15.38 ( 22.35 )
        Pain in Arm or Shoulder: C27D1(n= 3, 49)
    11.11 ( 19.24 )
    14.97 ( 23.63 )
        Pain in Arm or Shoulder: C28D1(n= 2, 45)
    0.00 ( 0.00 )
    11.85 ( 19.01 )
        Pain in Arm or Shoulder: C29D1(n= 2, 37)
    0.00 ( 0.00 )
    10.81 ( 22.30 )
        Pain in Arm or Shoulder: C30D1(n= 1, 30)
    0.00 ( 99999 )
    10.00 ( 21.71 )
        Pain in Arm or Shoulder: C31D1(n= 0, 23)
    00000 ( 00000 )
    10.14 ( 21.17 )
        Pain in Arm or Shoulder: C32D1(n= 0, 22)
    00000 ( 00000 )
    13.64 ( 26.55 )
        Pain in Arm or Shoulder: C33D1(n= 0, 15)
    00000 ( 00000 )
    20.00 ( 27.60 )
        Pain in Arm or Shoulder: C34D1(n= 0, 14)
    00000 ( 00000 )
    16.67 ( 28.49 )
        Pain in Arm or Shoulder: C35D1(n= 0, 11)
    00000 ( 00000 )
    27.27 ( 32.72 )
        Pain in Arm or Shoulder: C36D1(n= 0, 8)
    00000 ( 00000 )
    16.67 ( 35.63 )
        Pain in Arm or Shoulder: C37D1(n= 0, 5)
    00000 ( 00000 )
    33.33 ( 47.14 )
        Pain in Arm or Shoulder: C38D1(n= 0, 2)
    00000 ( 00000 )
    0.00 ( 0.00 )
        Pain in Arm or Shoulder: EOT(n= 264, 242)
    21.72 ( 30.48 )
    23.14 ( 29.55 )
        Pain in Arm or Shoulder: Pro Week 6 Pd(n= 0,1)
    00000 ( 00000 )
    66.67 ( 99999 )
        Pain in Arm or Shoulder: Survival FU 1 (n= 2, 1)
    83.33 ( 23.57 )
    33.33 ( 99999 )
    No statistical analyses for this end point

    Secondary: EORTC QLQ-LC13 Questionnaire Score: Pain in Chest

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    End point title
    		 EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
    End point description
    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 pain in chest. The PP-ITT analysis set. 'n'=participants evaluated for this measure at specific time point for each group respectively. '99999' denotes data not reported because SD was non-estimable since only 1 participant was evaluated for this category. '00000' denotes data not reported because no participant was evaluated for this category.
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Pain in Chest: Baseline (n= 385, 403)
    17.92 ( 25.33 )
    19.52 ( 26.49 )
        Pain in Chest: C2D1(n= 332, 356)
    16.67 ( 24.65 )
    15.26 ( 22.68 )
        Pain in Chest: C3D1(n= 249, 296)
    14.59 ( 21.92 )
    15.43 ( 23.42 )
        Pain in Chest: C4D1(n= 217, 268)
    14.44 ( 22.37 )
    14.43 ( 23.77 )
        Pain in Chest: C5D1(n= 164, 233)
    11.99 ( 18.42 )
    12.16 ( 19.82 )
        Pain in Chest: C6D1(n= 145, 217)
    12.18 ( 19.96 )
    12.60 ( 21.40 )
        Pain in Chest: C7D1(n= 86, 184)
    12.40 ( 19.83 )
    11.78 ( 20.91 )
        Pain in Chest: C8D1(n=69, 164)
    10.63 ( 20.21 )
    14.02 ( 21.52 )
        Pain in Chest: C9D1(n= 49, 149)
    7.48 ( 17.03 )
    10.74 ( 20.96 )
        Pain in Chest: C10D1(n= 46, 142)
    5.07 ( 12.11 )
    8.45 ( 19.62 )
        Pain in Chest: C11D1(n= 36, 127)
    3.70 ( 10.62 )
    9.45 ( 22.18 )
        Pain in Chest: C12D1(n= 30, 128)
    3.33 ( 10.17 )
    8.85 ( 17.49 )
        Pain in Chest: C13D1(n= 19, 120)
    3.51 ( 10.51 )
    7.50 ( 16.99 )
        Pain in Chest: C14D1(n= 18, 118)
    5.56 ( 12.78 )
    7.63 ( 15.96 )
        Pain in Chest: C15D1(n= 16, 109)
    6.25 ( 13.44 )
    8.56 ( 18.37 )
        Pain in Chest: C16D1(n= 13, 105)
    5.13 ( 12.52 )
    8.25 ( 16.53 )
        Pain in Chest: C17D1(n= 11, 94)
    0.00 ( 0.00 )
    8.87 ( 20.84 )
        Pain in Chest: C18D1(n= 10, 89)
    6.67 ( 14.05 )
    7.49 ( 15.69 )
        Pain in Chest: C19D1(n= 9, 80)
    7.41 ( 14.70 )
    7.50 ( 19.10 )
        Pain in Chest: C20D1(n= 9, 76)
    3.70 ( 11.11 )
    10.09 ( 20.38 )
        Pain in Chest: C21D1(n= 9, 71)
    0.00 ( 0.00 )
    7.98 ( 15.39 )
        Pain in Chest: C22D1(n= 8, 66)
    4.17 ( 11.78 )
    7.58 ( 16.33 )
        Pain in Chest: C23D1(n= 8, 62)
    4.17 ( 11.78 )
    7.53 ( 17.51 )
        Pain in Chest: C24D1(n= 5, 61)
    0.00 ( 0.00 )
    8.20 ( 15.70 )
        Pain in Chest: C25D1(n= 3, 57)
    0.00 ( 0.00 )
    8.77 ( 16.09 )
        Pain in Chest: C26D1(n= 2, 52)
    0.00 ( 0.00 )
    10.90 ( 19.49 )
        Pain in Chest: C27D1(n= 3, 49)
    11.11 ( 19.24 )
    8.84 ( 18.97 )
        Pain in Chest: C28D1(n= 2, 45)
    0.00 ( 0.00 )
    8.15 ( 16.14 )
        Pain in Chest: C29D1(n= 2, 37)
    0.00 ( 0.00 )
    8.11 ( 16.49 )
        Pain in Chest: C30D1(n= 1, 31)
    0.00 ( 99999 )
    5.38 ( 12.46 )
        Pain in Chest: C31D1(n= 0, 24)
    00000 ( 00000 )
    4.17 ( 11.26 )
        Pain in Chest: C32D1(n= 0, 23)
    00000 ( 00000 )
    13.04 ( 19.43 )
        Pain in Chest: C33D1(n= 0, 16)
    00000 ( 00000 )
    14.58 ( 24.25 )
        Pain in Chest: C34D1(n= 0, 14)
    00000 ( 00000 )
    14.29 ( 25.20 )
        Pain in Chest: C35D1(n= 0, 11)
    00000 ( 00000 )
    6.06 ( 13.48 )
        Pain in Chest: C36D1(n= 0, 8)
    00000 ( 00000 )
    4.17 ( 11.78 )
        Pain in Chest: C37D1(n= 0, 5)
    00000 ( 00000 )
    6.67 ( 14.91 )
        Pain in Chest: C38D1(n= 0, 2)
    00000 ( 00000 )
    0.00 ( 0.00 )
        Pain in Chest: EOT(n= 265, 245)
    18.99 ( 26.35 )
    19.46 ( 26.95 )
        Pain in Chest: Pro Week 6 Pd(n= 0,1)
    00000 ( 00000 )
    0.00 ( 99999 )
        Pain in Chest: Survival FU 1 (n= 2, 1)
    50.00 ( 70.71 )
    33.33 ( 99999 )
    No statistical analyses for this end point

    Secondary: EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy

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    End point title
    		 EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
    End point description
    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 peripheral neuropathy. The PP-ITT analysis set. 'n'=participants evaluated for this measure at specific time point for each group respectively. '99999' denotes data not reported because SD was non-estimable since only 1 participant was evaluated for this category. '00000' denotes data not reported because no participant was evaluated for this category.
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Peripheral Neuropathy: Baseline (n= 386, 406)
    19.26 ( 28.94 )
    19.21 ( 27.77 )
        Peripheral Neuropathy: C2D1(n= 335, 358)
    25.57 ( 29.63 )
    20.02 ( 27.21 )
        Peripheral Neuropathy: C3D1(n= 250, 300)
    25.60 ( 29.16 )
    17.78 ( 25.04 )
        Peripheral Neuropathy: C4D1(n= 221, 272)
    28.05 ( 29.94 )
    17.77 ( 25.75 )
        Peripheral Neuropathy: C5D1(n= 165, 235)
    29.29 ( 28.94 )
    18.44 ( 25.97 )
        Peripheral Neuropathy: C6D1(n= 147, 221)
    31.97 ( 30.69 )
    17.50 ( 25.34 )
        Peripheral Neuropathy: C7D1(n= 86, 185)
    31.01 ( 30.59 )
    18.02 ( 25.29 )
        Peripheral Neuropathy: C8D1(n=70, 167)
    35.24 ( 26.55 )
    17.56 ( 25.30 )
        Peripheral Neuropathy: C9D1(n= 50, 150)
    36.00 ( 29.23 )
    15.78 ( 24.02 )
        Peripheral Neuropathy: C10D1(n= 47, 143)
    36.17 ( 30.16 )
    18.18 ( 25.86 )
        Peripheral Neuropathy: C11D1(n= 37, 129)
    27.93 ( 24.23 )
    17.05 ( 24.69 )
        Peripheral Neuropathy: C12D1(n= 30, 129)
    30.00 ( 25.30 )
    17.57 ( 23.96 )
        Peripheral Neuropathy: C13D1(n= 19, 121)
    26.32 ( 21.02 )
    17.91 ( 25.83 )
        Peripheral Neuropathy: C14D1(n= 18, 119)
    25.93 ( 21.56 )
    17.09 ( 23.72 )
        Peripheral Neuropathy: C15D1(n= 15, 110)
    24.44 ( 15.26 )
    17.58 ( 21.99 )
        Peripheral Neuropathy: C16D1(n= 13, 105)
    20.51 ( 16.88 )
    17.14 ( 24.07 )
        Peripheral Neuropathy: C17D1(n= 11, 95)
    21.21 ( 16.82 )
    19.30 ( 26.44 )
        Peripheral Neuropathy: C18D1(n= 10, 90)
    23.33 ( 22.50 )
    18.15 ( 26.52 )
        Peripheral Neuropathy: C19D1(n= 9, 82)
    14.81 ( 17.57 )
    20.33 ( 26.06 )
        Peripheral Neuropathy: C20D1(n= 9, 78)
    22.22 ( 23.57 )
    17.52 ( 26.17 )
        Peripheral Neuropathy: C21D1(n= 9, 73)
    29.63 ( 20.03 )
    18.72 ( 25.45 )
        Peripheral Neuropathy: C22D1(n= 7, 66)
    23.81 ( 16.26 )
    15.66 ( 23.55 )
        Peripheral Neuropathy: C23D1(n= 8, 64)
    16.67 ( 17.82 )
    20.31 ( 22.71 )
        Peripheral Neuropathy: C24D1(n= 5, 62)
    13.33 ( 18.26 )
    20.43 ( 22.87 )
        Peripheral Neuropathy: C25D1(n= 3, 58)
    11.11 ( 19.24 )
    18.39 ( 20.87 )
        Peripheral Neuropathy: C26D1(n= 2, 53)
    16.67 ( 23.57 )
    20.13 ( 25.60 )
        Peripheral Neuropathy: C27D1(n= 3, 50)
    11.11 ( 19.24 )
    19.33 ( 24.36 )
        Peripheral Neuropathy: C28D1(n= 2, 46)
    0.00 ( 0.00 )
    19.57 ( 22.85 )
        Peripheral Neuropathy: C29D1(n= 2, 38)
    0.00 ( 0.00 )
    19.30 ( 22.77 )
        Peripheral Neuropathy: C30D1(n= 1, 31)
    0.00 ( 99999 )
    20.43 ( 28.12 )
        Peripheral Neuropathy: C31D1(n= 0, 24)
    00000 ( 00000 )
    23.61 ( 26.88 )
        Peripheral Neuropathy: C32D1(n= 0, 23)
    00000 ( 00000 )
    18.84 ( 22.08 )
        Peripheral Neuropathy: C33D1(n= 0, 16)
    00000 ( 00000 )
    22.92 ( 20.07 )
        Peripheral Neuropathy: C34D1(n= 0, 14)
    00000 ( 00000 )
    19.05 ( 21.54 )
        Peripheral Neuropathy: C35D1(n= 0, 11)
    00000 ( 00000 )
    15.15 ( 17.41 )
        Peripheral Neuropathy: C36D1(n= 0, 8)
    00000 ( 00000 )
    8.33 ( 15.43 )
        Peripheral Neuropathy: C37D1(n= 0, 5)
    00000 ( 00000 )
    26.67 ( 27.89 )
        Peripheral Neuropathy: C38D1(n= 0, 2)
    00000 ( 00000 )
    16.67 ( 23.57 )
        Peripheral Neuropathy: EOT(n= 262, 244)
    31.81 ( 31.53 )
    19.54 ( 27.32 )
        Peripheral Neuropathy: Pro Week 6 Pd(n= 0,1)
    00000 ( 00000 )
    66.67 ( 99999 )
        Peripheral Neuropathy: Survival FU 1 (n= 2, 1)
    50.00 ( 23.57 )
    33.33 ( 99999 )
    No statistical analyses for this end point

    Secondary: EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts

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    End point title
    		 EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
    End point description
    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 pain in other parts. The PP-ITT analysis set. 'n'=participants evaluated for this measure at specific time point for each group respectively. '99999' denotes data not reported because SD was non-estimable since only 1 participant was evaluated for this category. '00000' denotes data not reported because no participant was evaluated for this category.
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Pain in Other Parts: Baseline (n= 373, 402)
    27.52 ( 30.41 )
    27.94 ( 31.52 )
        Pain in Other Parts: C2D1(n= 320, 347)
    29.58 ( 30.44 )
    27.76 ( 30.53 )
        Pain in Other Parts: C3D1(n= 239, 286)
    22.87 ( 27.79 )
    25.87 ( 29.79 )
        Pain in Other Parts: C4D1(n= 211, 263)
    21.48 ( 26.86 )
    23.45 ( 26.92 )
        Pain in Other Parts: C5D1(n= 154, 230)
    21.21 ( 26.63 )
    22.32 ( 27.24 )
        Pain in Other Parts: C6D1(n= 139, 214)
    22.78 ( 25.39 )
    21.50 ( 27.88 )
        Pain in Other Parts: C7D1(n= 81, 180)
    23.05 ( 28.21 )
    24.63 ( 29.56 )
        Pain in Other Parts: C8D1(n=65, 158)
    24.10 ( 28.57 )
    18.35 ( 24.54 )
        Pain in Other Parts: C9D1(n= 44, 135)
    18.18 ( 28.26 )
    21.48 ( 28.35 )
        Pain in Other Parts: C10D1(n= 44, 136)
    15.15 ( 23.24 )
    21.57 ( 28.84 )
        Pain in Other Parts: C11D1(n= 34, 123)
    14.71 ( 23.49 )
    20.05 ( 27.90 )
        Pain in Other Parts: C12D1(n= 26, 122)
    8.97 ( 17.78 )
    16.67 ( 25.80 )
        Pain in Other Parts: C13D1(n= 17, 113)
    17.65 ( 23.91 )
    19.76 ( 25.05 )
        Pain in Other Parts: C14D1(n= 18, 115)
    18.52 ( 23.49 )
    22.03 ( 29.58 )
        Pain in Other Parts: C15D1(n= 15, 106)
    6.67 ( 13.80 )
    19.18 ( 25.18 )
        Pain in Other Parts: C16D1(n= 13, 105)
    20.51 ( 21.68 )
    21.90 ( 26.89 )
        Pain in Other Parts: C17D1(n= 11, 93)
    15.15 ( 22.92 )
    22.22 ( 27.51 )
        Pain in Other Parts: C18D1(n= 10, 89)
    13.33 ( 23.31 )
    22.10 ( 27.50 )
        Pain in Other Parts: C19D1(n= 9, 80)
    18.52 ( 24.22 )
    24.58 ( 29.88 )
        Pain in Other Parts: C20D1(n= 9, 74)
    25.93 ( 36.43 )
    21.17 ( 27.90 )
        Pain in Other Parts: C21D1(n= 8, 69)
    12.50 ( 17.25 )
    21.26 ( 31.30 )
        Pain in Other Parts: C22D1(n= 8, 62)
    20.83 ( 24.80 )
    18.82 ( 25.34 )
        Pain in Other Parts: C23D1(n= 8, 62)
    20.83 ( 30.54 )
    18.82 ( 23.86 )
        Pain in Other Parts: C24D1(n= 5, 61)
    26.67 ( 43.46 )
    19.67 ( 28.14 )
        Pain in Other Parts: C25D1(n= 3, 55)
    11.11 ( 19.24 )
    16.97 ( 26.35 )
        Pain in Other Parts: C26D1(n= 2, 50)
    16.67 ( 23.57 )
    18.67 ( 26.22 )
        Pain in Other Parts: C27D1(n= 3, 49)
    11.11 ( 19.24 )
    14.29 ( 21.52 )
        Pain in Other Parts: C28D1(n= 2, 44)
    0.00 ( 0.00 )
    15.15 ( 25.37 )
        Pain in Other Parts: C29D1(n= 2, 36)
    0.00 ( 0.00 )
    21.30 ( 26.61 )
        Pain in Other Parts: C30D1(n= 1, 30)
    0.00 ( 99999 )
    16.67 ( 30.01 )
        Pain in Other Parts: C31D1(n= 0, 23)
    00000 ( 00000 )
    11.59 ( 21.58 )
        Pain in Other Parts: C32D1(n= 0, 23)
    00000 ( 00000 )
    20.29 ( 27.96 )
        Pain in Other Parts: C33D1(n= 0, 15)
    00000 ( 00000 )
    11.11 ( 27.22 )
        Pain in Other Parts: C34D1(n= 0, 14)
    00000 ( 00000 )
    30.95 ( 33.24 )
        Pain in Other Parts: C35D1(n= 0, 10)
    00000 ( 00000 )
    26.67 ( 34.43 )
        Pain in Other Parts: C36D1(n= 0, 8)
    00000 ( 00000 )
    20.83 ( 35.36 )
        Pain in Other Parts: C37D1(n= 0, 5)
    00000 ( 00000 )
    33.33 ( 40.82 )
        Pain in Other Parts: C38D1(n= 0, 2)
    00000 ( 00000 )
    0.00 ( 0.00 )
        Pain in Other Parts: EOT(n= 250, 226)
    30.80 ( 32.97 )
    32.01 ( 33.89 )
        Pain in Other Parts: Pro Week 6 Pd(n= 0,1)
    00000 ( 00000 )
    0.00 ( 99999 )
        Pain in Other Parts: Survival FU 1 (n= 2, 1)
    83.33 ( 23.57 )
    66.67 ( 99999 )
    No statistical analyses for this end point

    Secondary: EORTC QLQ-LC13 Questionnaire Score: Sore Mouth

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    End point title
    		 EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
    End point description
    QLQ-LC13:13 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. The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. '99999' denotes data not reported because SD was non-estimable since only 1 participant was evaluated for this category. '00000' denotes data not reported because no participant was evaluated for this category.
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    425
    425
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Sore Mouth: Baseline (n= 387, 404)
    5.68 ( 16.34 )
    4.95 ( 15.32 )
        Sore Mouth: C2D1(n= 335, 357)
    15.52 ( 25.75 )
    7.10 ( 18.17 )
        Sore Mouth: C3D1(n= 252, 297)
    14.29 ( 23.59 )
    5.61 ( 14.18 )
        Sore Mouth: C4D1(n= 219, 270)
    14.00 ( 22.95 )
    4.81 ( 13.99 )
        Sore Mouth: C5D1(n= 165, 234)
    11.31 ( 19.65 )
    4.27 ( 13.49 )
        Sore Mouth: C6D1(n= 148, 218)
    13.29 ( 23.24 )
    4.13 ( 13.89 )
        Sore Mouth: C7D1(n= 87, 185)
    9.20 ( 20.77 )
    5.59 ( 15.50 )
        Sore Mouth: C8D1(n=70, 166)
    8.57 ( 16.73 )
    5.02 ( 14.96 )
        Sore Mouth: C9D1(n= 50, 151)
    6.00 ( 17.42 )
    3.09 ( 14.06 )
        Sore Mouth: C10D1(n= 47, 143)
    7.09 ( 15.44 )
    3.96 ( 14.53 )
        Sore Mouth: C11D1(n= 37, 130)
    4.50 ( 13.97 )
    3.33 ( 12.35 )
        Sore Mouth: C12D1(n= 30, 129)
    2.22 ( 8.46 )
    4.65 ( 14.87 )
        Sore Mouth: C13D1(n= 19, 121)
    1.75 ( 7.65 )
    5.23 ( 15.52 )
        Sore Mouth: C14D1(n= 18, 119)
    3.70 ( 10.78 )
    5.32 ( 15.64 )
        Sore Mouth: C15D1(n= 15, 110)
    0.00 ( 0.00 )
    4.24 ( 13.63 )
        Sore Mouth: C16D1(n= 13, 106)
    0.00 ( 0.00 )
    3.77 ( 16.15 )
        Sore Mouth: C17D1(n= 11, 95)
    3.03 ( 10.05 )
    6.32 ( 17.73 )
        Sore Mouth: C18D1(n= 10, 90)
    3.33 ( 10.54 )
    3.70 ( 11.66 )
        Sore Mouth: C19D1(n= 9, 82)
    0.00 ( 0.00 )
    4.47 ( 12.57 )
        Sore Mouth: C20D1(n= 9, 78)
    0.00 ( 0.00 )
    5.56 ( 15.59 )
        Sore Mouth: C21D1(n= 9, 73)
    0.00 ( 0.00 )
    7.76 ( 17.14 )
        Sore Mouth: C22D1(n= 8, 67)
    4.17 ( 11.78 )
    6.47 ( 17.64 )
        Sore Mouth: C23D1(n= 8, 64)
    4.17 ( 11.78 )
    6.25 ( 16.67 )
        Sore Mouth: C24D1(n= 5, 62)
    0.00 ( 0.00 )
    5.38 ( 13.75 )
        Sore Mouth: C25D1(n= 3, 57)
    0.00 ( 0.00 )
    3.51 ( 10.32 )
        Sore Mouth: C26D1(n= 3, 53)
    0.00 ( 0.00 )
    6.92 ( 13.65 )
        Sore Mouth: C27D1(n= 3, 50)
    0.00 ( 0.00 )
    4.00 ( 10.94 )
        Sore Mouth: C28D1(n= 2, 46)
    0.00 ( 0.00 )
    4.35 ( 11.35 )
        Sore Mouth: C29D1(n= 2, 38)
    0.00 ( 0.00 )
    3.51 ( 10.37 )
        Sore Mouth: C30D1(n= 1, 31)
    0.00 ( 99999 )
    4.30 ( 11.36 )
        Sore Mouth: C31D1(n= 0, 24)
    00000 ( 00000 )
    4.17 ( 11.26 )
        Sore Mouth: C32D1(n= 0, 23)
    00000 ( 00000 )
    4.35 ( 11.48 )
        Sore Mouth: C33D1(n= 0, 16)
    00000 ( 00000 )
    4.17 ( 11.39 )
        Sore Mouth: C34D1(n= 0, 14)
    00000 ( 00000 )
    9.52 ( 15.63 )
        Sore Mouth: C35D1(n= 0, 11)
    00000 ( 00000 )
    6.06 ( 13.48 )
        Sore Mouth: C36D1(n= 0, 8)
    00000 ( 00000 )
    4.17 ( 11.78 )
        Sore Mouth: C37D1(n= 0, 5)
    00000 ( 00000 )
    13.33 ( 29.81 )
        Sore Mouth: C38D1(n= 0, 2)
    00000 ( 00000 )
    0.00 ( 0.00 )
        Sore Mouth: EOT(n= 265, 243)
    11.57 ( 22.85 )
    7.00 ( 17.18 )
        Sore Mouth: Pro Week 6 Pd(n= 0,1)
    00000 ( 00000 )
    66.67 ( 99999 )
        Sore Mouth: Survival FU 1 (n= 2, 1)
    16.67 ( 23.57 )
    0.00 ( 99999 )
    No statistical analyses for this end point

    Secondary: PFS as Determined by Investigator Using RECIST v1.1: SP-ITT

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    End point title
    		 PFS as Determined by Investigator Using RECIST v1.1: SP-ITT
    End point description
    PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions. SP-ITT analysis set.
    End point type
    Secondary
    End point timeframe
    Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    612
    613
    Units: Months
        median (confidence interval 95%)
    3.8 (3.3 to 4.1)
    2.7 (2.4 to 2.9)
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    1225
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4981
    Method
    		 Logrank
    Parameter type
    		 Stratified Hazard Ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.08

    Secondary: Percentage of Participants With Objective Response as Determined Using RECIST v1.1: SP-ITT

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    End point title
    		 Percentage of Participants With Objective Response as Determined Using RECIST v1.1: SP-ITT
    End point description
    Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions. SP-ITT analysis set.
    End point type
    Secondary
    End point timeframe
    Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    612
    613
    Units: Percentage of Participants
        number (confidence interval 95%)
    11.8 (9.32 to 14.59)
    13.7 (11.08 to 16.68)
    No statistical analyses for this end point

    Secondary: DOR as Determined by Investigator Using RECIST v1.1: SP ITT

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    End point title
    		 DOR as Determined by Investigator Using RECIST v1.1: SP ITT
    End point description
    DOR:Duration from first tumor assessment that supports the participant's OR to PD or death due to any cause.CR:complete disappearance of all target lesions&non-target disease.All nodes,both target&non-target,must decrease to normal.No new lesions.PR:At least 30% decrease in sum of the diameters of all target&all new measurable lesions,taking as reference the baseline sum of diameters,in absence of CR.Participants without PD at time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at randomization date plus 1 day.PD:at least 20% increase in sum of diameters of target lesions compared to the smallest sum of diameters on-study&absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.’99999’:due to higher number of censored participants data not estimable.SP-ITT analysis set.
    End point type
    Secondary
    End point timeframe
    From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    72
    84
    Units: Months
        median (confidence interval 95%)
    6.3 (5.5 to 7.6)
    23.9 (12.8 to 999999)
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Unstratified Hazard Ratio
    Point estimate
    0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.21
         upper limit
    		 0.48

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to approximate 5.28 years.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Atezolizumab
    Reporting group 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.

    Reporting group title
    Docetaxel
    Reporting group description
    		 Docetaxel 75 mg/m^2 was administered 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.

    Serious adverse events
    		 Atezolizumab Docetaxel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    200 / 609 (32.84%)
    180 / 578 (31.14%)
         number of deaths (all causes)
    485
    494
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 609 (0.16%)
    2 / 578 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    3 / 609 (0.49%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superior vena cava syndrome
         subjects affected / exposed
    3 / 609 (0.49%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 609 (0.49%)
    3 / 578 (0.52%)
         occurrences causally related to treatment / all
    1 / 4
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Fatigue
         subjects affected / exposed
    2 / 609 (0.33%)
    4 / 578 (0.69%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    2 / 609 (0.33%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised oedema
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised oedema
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    2 / 609 (0.33%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    9 / 609 (1.48%)
    8 / 578 (1.38%)
         occurrences causally related to treatment / all
    4 / 11
    5 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 609 (0.16%)
    2 / 578 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    3 / 609 (0.49%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial obstruction
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 609 (0.33%)
    3 / 578 (0.52%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    13 / 609 (2.13%)
    7 / 578 (1.21%)
         occurrences causally related to treatment / all
    1 / 14
    1 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Emphysema
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    6 / 609 (0.99%)
    5 / 578 (0.87%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypoxia
         subjects affected / exposed
    3 / 609 (0.49%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    11 / 609 (1.81%)
    5 / 578 (0.87%)
         occurrences causally related to treatment / all
    1 / 12
    4 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural fistula
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    2 / 609 (0.33%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    6 / 609 (0.99%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    6 / 6
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    3 / 609 (0.49%)
    2 / 578 (0.35%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary embolism
         subjects affected / exposed
    9 / 609 (1.48%)
    2 / 578 (0.35%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary haemorrhage
         subjects affected / exposed
    1 / 609 (0.16%)
    2 / 578 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pulmonary oedema
         subjects affected / exposed
    1 / 609 (0.16%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory failure
         subjects affected / exposed
    3 / 609 (0.49%)
    2 / 578 (0.35%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachypnoea
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 609 (0.16%)
    2 / 578 (0.35%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status change
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 609 (0.00%)
    5 / 578 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Burns third degree
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    3 / 609 (0.49%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 609 (0.16%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematuria
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 609 (0.16%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture displacement
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 609 (0.00%)
    2 / 578 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 609 (0.16%)
    3 / 578 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    2 / 609 (0.33%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 609 (0.33%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    3 / 609 (0.49%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 609 (0.00%)
    2 / 578 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 609 (0.16%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia paroxysmal
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral artery embolism
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral thrombosis
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    2 / 609 (0.33%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depressed level of consciousness
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 609 (0.16%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    2 / 609 (0.33%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukoencephalopathy
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    3 / 609 (0.49%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 609 (0.16%)
    3 / 578 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 609 (0.82%)
    7 / 578 (1.21%)
         occurrences causally related to treatment / all
    0 / 6
    4 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 609 (0.00%)
    37 / 578 (6.40%)
         occurrences causally related to treatment / all
    0 / 0
    40 / 41
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 609 (0.00%)
    3 / 578 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinopathy
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 609 (0.16%)
    4 / 578 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    2 / 609 (0.33%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 609 (0.16%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    2 / 609 (0.33%)
    2 / 578 (0.35%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 609 (0.16%)
    7 / 578 (1.21%)
         occurrences causally related to treatment / all
    0 / 1
    6 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal perforation
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 609 (0.16%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faeces discoloured
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Melaena
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 609 (0.33%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal fistula
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal obstruction
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 609 (0.16%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 609 (0.16%)
    5 / 578 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute hepatic failure
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 609 (0.16%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    2 / 609 (0.33%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Pemphigoid
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pruritus
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pruritus generalised
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 609 (0.16%)
    4 / 578 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Henoch−Schonlein purpura nephritis
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 609 (0.33%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    3 / 609 (0.49%)
    2 / 578 (0.35%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    4 / 609 (0.66%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 609 (0.33%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 609 (0.16%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal sepsis
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 609 (0.16%)
    2 / 578 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 609 (0.16%)
    2 / 578 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 609 (0.16%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 609 (0.00%)
    2 / 578 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis infectious
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile infection
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 609 (0.16%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal fungal infection
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 609 (0.00%)
    2 / 578 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 609 (0.33%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 609 (0.49%)
    3 / 578 (0.52%)
         occurrences causally related to treatment / all
    0 / 7
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    3 / 609 (0.49%)
    3 / 578 (0.52%)
         occurrences causally related to treatment / all
    0 / 3
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    3 / 609 (0.49%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 609 (0.00%)
    2 / 578 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paronychia
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    2 / 609 (0.33%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural infection
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    20 / 609 (3.28%)
    34 / 578 (5.88%)
         occurrences causally related to treatment / all
    3 / 23
    11 / 36
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Pneumonia bacterial
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    2 / 609 (0.33%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    8 / 609 (1.31%)
    4 / 578 (0.69%)
         occurrences causally related to treatment / all
    1 / 8
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    Sepsis
         subjects affected / exposed
    5 / 609 (0.82%)
    2 / 578 (0.35%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Septic shock
         subjects affected / exposed
    1 / 609 (0.16%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 609 (0.00%)
    2 / 578 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 609 (0.16%)
    3 / 578 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 609 (0.16%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    3 / 609 (0.49%)
    0 / 578 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 609 (0.00%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 609 (0.16%)
    1 / 578 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Atezolizumab Docetaxel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    541 / 609 (88.83%)
    535 / 578 (92.56%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    42 / 609 (6.90%)
    12 / 578 (2.08%)
         occurrences all number
    53
    13
    Alanine aminotransferase increased
         subjects affected / exposed
    36 / 609 (5.91%)
    14 / 578 (2.42%)
         occurrences all number
    54
    16
    Neutrophil count decreased
         subjects affected / exposed
    3 / 609 (0.49%)
    50 / 578 (8.65%)
         occurrences all number
    6
    223
    Weight decreased
         subjects affected / exposed
    56 / 609 (9.20%)
    30 / 578 (5.19%)
         occurrences all number
    71
    33
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    48 / 609 (7.88%)
    32 / 578 (5.54%)
         occurrences all number
    61
    37
    Dysgeusia
         subjects affected / exposed
    18 / 609 (2.96%)
    48 / 578 (8.30%)
         occurrences all number
    20
    69
    Headache
         subjects affected / exposed
    62 / 609 (10.18%)
    46 / 578 (7.96%)
         occurrences all number
    74
    47
    Neuropathy peripheral
         subjects affected / exposed
    27 / 609 (4.43%)
    65 / 578 (11.25%)
         occurrences all number
    29
    75
    Paraesthesia
         subjects affected / exposed
    23 / 609 (3.78%)
    45 / 578 (7.79%)
         occurrences all number
    26
    58
    Peripheral sensory neuropathy
         subjects affected / exposed
    5 / 609 (0.82%)
    43 / 578 (7.44%)
         occurrences all number
    6
    59
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    12 / 609 (1.97%)
    88 / 578 (15.22%)
         occurrences all number
    17
    118
    Anaemia
         subjects affected / exposed
    71 / 609 (11.66%)
    130 / 578 (22.49%)
         occurrences all number
    98
    184
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    117 / 609 (19.21%)
    113 / 578 (19.55%)
         occurrences all number
    173
    177
    Chest pain
         subjects affected / exposed
    55 / 609 (9.03%)
    25 / 578 (4.33%)
         occurrences all number
    64
    30
    Fatigue
         subjects affected / exposed
    165 / 609 (27.09%)
    206 / 578 (35.64%)
         occurrences all number
    223
    313
    Influenza like illness
         subjects affected / exposed
    35 / 609 (5.75%)
    14 / 578 (2.42%)
         occurrences all number
    52
    18
    Malaise
         subjects affected / exposed
    15 / 609 (2.46%)
    29 / 578 (5.02%)
         occurrences all number
    18
    45
    Oedema peripheral
         subjects affected / exposed
    55 / 609 (9.03%)
    82 / 578 (14.19%)
         occurrences all number
    58
    108
    Mucosal inflammation
         subjects affected / exposed
    9 / 609 (1.48%)
    41 / 578 (7.09%)
         occurrences all number
    13
    61
    Pyrexia
         subjects affected / exposed
    108 / 609 (17.73%)
    70 / 578 (12.11%)
         occurrences all number
    145
    89
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    6 / 609 (0.99%)
    33 / 578 (5.71%)
         occurrences all number
    7
    36
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    23 / 609 (3.78%)
    33 / 578 (5.71%)
         occurrences all number
    27
    40
    Constipation
         subjects affected / exposed
    111 / 609 (18.23%)
    82 / 578 (14.19%)
         occurrences all number
    126
    101
    Diarrhoea
         subjects affected / exposed
    100 / 609 (16.42%)
    138 / 578 (23.88%)
         occurrences all number
    147
    190
    Nausea
         subjects affected / exposed
    110 / 609 (18.06%)
    131 / 578 (22.66%)
         occurrences all number
    133
    189
    Vomiting
         subjects affected / exposed
    75 / 609 (12.32%)
    61 / 578 (10.55%)
         occurrences all number
    93
    74
    Stomatitis
         subjects affected / exposed
    21 / 609 (3.45%)
    62 / 578 (10.73%)
         occurrences all number
    23
    81
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    146 / 609 (23.97%)
    107 / 578 (18.51%)
         occurrences all number
    200
    124
    Haemoptysis
         subjects affected / exposed
    40 / 609 (6.57%)
    28 / 578 (4.84%)
         occurrences all number
    50
    35
    Dyspnoea
         subjects affected / exposed
    117 / 609 (19.21%)
    108 / 578 (18.69%)
         occurrences all number
    146
    122
    Productive cough
         subjects affected / exposed
    36 / 609 (5.91%)
    21 / 578 (3.63%)
         occurrences all number
    37
    22
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    5 / 609 (0.82%)
    205 / 578 (35.47%)
         occurrences all number
    5
    232
    Dry skin
         subjects affected / exposed
    30 / 609 (4.93%)
    34 / 578 (5.88%)
         occurrences all number
    32
    36
    Nail disorder
         subjects affected / exposed
    1 / 609 (0.16%)
    30 / 578 (5.19%)
         occurrences all number
    1
    30
    Rash
         subjects affected / exposed
    65 / 609 (10.67%)
    51 / 578 (8.82%)
         occurrences all number
    94
    66
    Pruritus
         subjects affected / exposed
    57 / 609 (9.36%)
    18 / 578 (3.11%)
         occurrences all number
    90
    29
    Psychiatric disorders
    Depression
         subjects affected / exposed
    31 / 609 (5.09%)
    6 / 578 (1.04%)
         occurrences all number
    32
    6
    Insomnia
         subjects affected / exposed
    56 / 609 (9.20%)
    43 / 578 (7.44%)
         occurrences all number
    66
    55
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    80 / 609 (13.14%)
    59 / 578 (10.21%)
         occurrences all number
    113
    75
    Back pain
         subjects affected / exposed
    70 / 609 (11.49%)
    41 / 578 (7.09%)
         occurrences all number
    81
    45
    Musculoskeletal pain
         subjects affected / exposed
    69 / 609 (11.33%)
    24 / 578 (4.15%)
         occurrences all number
    85
    26
    Myalgia
         subjects affected / exposed
    44 / 609 (7.22%)
    90 / 578 (15.57%)
         occurrences all number
    48
    116
    Pain in extremity
         subjects affected / exposed
    56 / 609 (9.20%)
    38 / 578 (6.57%)
         occurrences all number
    73
    43
    Musculoskeletal chest pain
         subjects affected / exposed
    33 / 609 (5.42%)
    7 / 578 (1.21%)
         occurrences all number
    38
    7
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    39 / 609 (6.40%)
    21 / 578 (3.63%)
         occurrences all number
    51
    24
    Upper respiratory tract infection
         subjects affected / exposed
    41 / 609 (6.73%)
    15 / 578 (2.60%)
         occurrences all number
    54
    25
    Urinary tract infection
         subjects affected / exposed
    22 / 609 (3.61%)
    30 / 578 (5.19%)
         occurrences all number
    28
    34
    Bronchitis
         subjects affected / exposed
    34 / 609 (5.58%)
    24 / 578 (4.15%)
         occurrences all number
    46
    33
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    150 / 609 (24.63%)
    135 / 578 (23.36%)
         occurrences all number
    179
    202

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Feb 2014
    The exclusion criterion for participants with a positive human immunodeficiency virus (HIV) test was updated. The timing of vital signs with the intravenous infusions of atezolizumab or docetaxel was clarified and made consistent throughout the protocol.
    05 Aug 2014
    The treatment duration for atezolizumab was modified to allow participants to be treated until participants are no longer experiencing clinical benefit, accordingly, the 16-cycle or 12-month initial treatment, follow-up, and re-treatment periods no longer apply. An exclusion criterion regarding known tumor PD-L1 expression status from other clinical trials was added to ensure a natural distribution of the prevalence of PD-L1 expression levels. All instances of “PD-L1 positive” were replaced by “moderate or high PD-L1 staining (IHC 2/3)” and all instances of “PD-L1 negative” were replaced by “no or low PD-L1 staining (IHC 0/1)”.
    02 Dec 2014
    Planned PD-L1 expression subgroups for analysis were amended to include PD-L1 expression on TCs in addition to ICs. The sample size was increased from 850 to 1100 participants to allow for testing participants with TC3 or IC3 as first step in the hierarchy. The statistical section was amended to change the procedure used to control the type I error.
    06 Oct 2015
    The name of the test product, MPDL3280A, was changed to atezolizumab throughout the document because this is now the world health organization (WHO)-approved nonproprietary name. The recent update to the Atezolizumab Investigator’s Brochure (IB) has outlined more stringent approaches for the management of immune-mediated toxicity. Systemic immune activation (SIA) was identified as a potential risk of atezolizumab when given in combination with other immunomodulating agents.
    28 Jan 2016
    The statistical section was amended to reflect changes in the statistical testing procedure on the basis of the primary analysis of the POPLAR study (Study GO28753). The primary analysis population was changed to the 850 first randomized participants, which would provide sufficient power to detect targeted OS benefits in all 850 first randomized participants and the TC1/2/3 or IC1/2/3 subgroup among these 850 participants with adequate follow-up.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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