Trial Outcomes & Findings for A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer (NCT NCT04426825)

Last Updated: 2024-05-21

Results Overview

Objective response rate (ORR) was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions \>=4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Baseline up to approximately 10 months

Results posted on

2024-05-21

Participant Flow

This study was conducted at multiple investigational sites in China

Participant milestones

Participant milestones
Measure	Atezolizumab Plus Bevacizumab Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Overall Study STARTED	23
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Atezolizumab Plus Bevacizumab Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Overall Study Death	17
Overall Study Lost to Follow-up	1
Overall Study Study terminated by sponsor	5

Baseline Characteristics

A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atezolizumab Plus Bevacizumab n=23 Participants Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Age, Continuous	59.8 Years STANDARD_DEVIATION 10.07 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	23 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Smoking History Never	16 Participants n=5 Participants
Smoking History Current	0 Participants n=5 Participants
Smoking History Previous	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to approximately 10 months

Population: The evaluable population included all enrolled participants who received any amount of study treatment, had baseline and at least one post-baseline efficacy measurement.

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab n=22 Participants Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Objective Response Rate (ORR)	18.2 Percentage of Participants Interval 5.19 to 40.28

SECONDARY outcome

Timeframe: Baseline up to approximately 2.5 years

Population: The full analysis set (FAS) population included all enrolled participants who received any amount of at least one dose of any study treatment. The analysis population for this outcome measures included participants with a confirmed response (CR or PR).

Duration of objective response (DOR) was defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause whichever occurs first, as determined by the investigator according to RECIST v1.1.

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab n=4 Participants Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Duration of Objective Response (DOR)	6.36 Months Interval 2.66 to NA = not estimable due to the limited number of events observed

SECONDARY outcome

Timeframe: Baseline up to approximately 2.5 years

Population: The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment. The analysis population for this outcome measures included participants with a confirmed response (CR or PR).

Time to response (TTR) was defined as the time from the start of the treatment to the first objective tumor response observed for participants who achieved CR or PR, as determined by the investigator according to RECIST v1.1.

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab n=4 Participants Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Time to Response (TTR)	1.577 Months Standard Deviation 0.490

SECONDARY outcome

Timeframe: Baseline up to approximately 2.5 years

Population: The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.

Disease control rate (DCR) was defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to RECIST v1.1.

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab n=23 Participants Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Disease Control Rate (DCR)	65.2 Percentage of Participants Interval 42.73 to 83.62

SECONDARY outcome

Timeframe: Baseline until death due to any cause (up to approximately 2.5 years)

Population: The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.

OS after enrollment was defined as the time from enrollment to death from any cause.

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab n=23 Participants Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Overall Survival (OS)	14.06 Months Interval 8.8 to 22.14

SECONDARY outcome

Timeframe: Baseline up to approximately 2.5 years

Population: The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.

Progression-free survival (PFS) was defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1.

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab n=23 Participants Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Progression-Free Survival (PFS)	2.76 Months Interval 1.35 to 4.07

SECONDARY outcome

Timeframe: Baseline to 6 months and 12 months

Population: The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.

PFS rate at 6 and 12 months is defined as the percentage of participants who have not experienced disease progression or death from any cause at 6 and 12 months, as determined by the investigator according to RECIST v1.1.

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab n=23 Participants Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
PFS Rate at 6 and 12 Months 6 months	13.91 Percentage of participants Interval 3.49 to 31.36
PFS Rate at 6 and 12 Months 12 months	4.64 Percentage of participants Interval 0.33 to 19.26

SECONDARY outcome

Timeframe: Baseline to 1 and 2 Years

Population: The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.

OS rate at 1 and 2 years was defined as the percentage of participants who have not experienced death from any cause at 1 and 2 years.

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab n=23 Participants Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
OS Rate at 1 and 2 Years 2 years	30.43 Percentage of participants Interval 13.54 to 49.28
OS Rate at 1 and 2 Years 1 year	52.17 Percentage of participants Interval 30.51 to 70.01

SECONDARY outcome

Timeframe: Baseline up to approximately 2.5 years

Population: The safety population is defined as all enrolled participants who received any amount of at least one dose of any study treatment.

Percentage of participants with adverse events.

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab n=23 Participants Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Percentage of Participants With Adverse Events	23 Participants

SECONDARY outcome

Timeframe: Baseline up to approximately 2.5 years

Population: The safety population is defined as all enrolled participants who received any amount of at least one dose of any study treatment.

Percentage of serious and non-serious immune-mediated adverse events related to atezolizumab treatment. The AESIs were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria. The grading is as follows: Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE, Grade 5=Death related to AE.

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab n=23 Participants Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Percentage of Participants With Serious and Non-Serious Immune-Mediated Adverse Events (irAEs) Serious irAEs	1 Participants
Percentage of Participants With Serious and Non-Serious Immune-Mediated Adverse Events (irAEs) Non-serious irAEs	7 Participants

SECONDARY outcome

Timeframe: Baseline up to approximately 2.5 years

Population: The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.

Objective response rate (ORR) is defined as the proportion of participants with a complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to Modified RECIST v1.1 (iRECIST).

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab n=23 Participants Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Objective Response Rate (ORR) According to iRECIST	17.4 Percentage of Participants Interval 4.95 to 38.78

SECONDARY outcome

Timeframe: Baseline up to 2 years and approximately 5 months

Population: The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.

Disease control rate (DCR) is defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to modified RECIST v1.1 (iRECIST).

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab n=23 Participants Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Disease Control Rate (DCR) According to iRECIST	65.2 Percentage of Participants Interval 42.73 to 83.62

SECONDARY outcome

Timeframe: Baseline up to approximately 2.5 years

Duration of objective response (DOR) is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause whichever occurs first, as determined by the investigator according to modified RECIST v1.1 (iRECIST).

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab n=4 Participants Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Duration of Objective Response (DOR) According to iRECIST	6.36 Months Interval 2.66 to NA = not estimable; could not be calculated due to too few events.

SECONDARY outcome

Timeframe: Baseline up to approximately 2.5 years

Population: The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.

Progression-free survival (PFS) is defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator according to modified RECIST v1.1 (iRECIST).

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab n=23 Participants Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Progression-Free Survival (PFS) According to iRECIST	2.76 Months Interval 1.35 to 4.07

SECONDARY outcome

Timeframe: Baseline up to approximately 12 months

Population: The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.

Progression-free survival (PFS) rate is defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first at 12 months, as determined by the investigator according to modified RECIST v1.1 (iRECIST).

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab n=23 Participants Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Progression-Free Survival (PFS) Rate at 12 Months According to iRECIST	4.64 Months Interval 0.33 to 19.26

SECONDARY outcome

Timeframe: Baselsine up to approximately 1 year

Time to deterioration (TTD) using European Organization for Research and treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (QLQ C30) and its Lung Cancer Module (QLQ LC13) is defined as the time from baseline to the first time the patient's score shows a \>=10 points increase above baseline in any of the following EORTC-transformed symptom subscale scores (whichever occurs first): cough, dyspnoea (single item), dyspnoea (multi-item subscale), chest pain, or arm/shoulder pain, whichever occurred first. Scores ranged from 0-10. A higher score represented more severe symptoms.

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab n=22 Participants Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Time to Deterioation (TTD) Using EORTC Dyspnoea (multi-item)	NA Months NA = too few events to calculate the median, upper and lower CI
Time to Deterioation (TTD) Using EORTC Cough	NA Months Interval 3.48 to NA = too few events to calculate the median and upper confidence interval (CI)
Time to Deterioation (TTD) Using EORTC Dyspnoea (single-item Q33)	NA Months NA = too few events to calculate the median, upper and lower CI
Time to Deterioation (TTD) Using EORTC Dyspnoea (single-item Q34)	NA Months NA = too few events to calculate the median, upper and lower CI
Time to Deterioation (TTD) Using EORTC Dyspnoea (single-item Q35)	NA Months NA = too few events to calculate the median, upper and lower CI
Time to Deterioation (TTD) Using EORTC Chest pain	NA Months Interval 2.1 to NA = too few events to calculate the median, upper CI
Time to Deterioation (TTD) Using EORTC Arm/shoulder pain	NA Months NA = too few events to calculate the median, upper and lower CI

SECONDARY outcome

Timeframe: Baseline up to approximately 1 year

Population: The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment. The number of participants in the FAS with a non-missing baseline PRO assessment are presented. As each participant had different treatment cycles, this resulted in different numbers of participants analyzed per cycle.

The 30-item EORTC QLQ-C30 version 3 is composed by five multi-item function scales (physical, role, cognitive, emotional, and social), three multi-item symptom scales (fatigue, nausea and vomiting, and pain), six single-item symptom scales (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties), and a two-item global quality of life scale. All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for the functional and general health areas represent better functional status and quality of life. Higher scores for the symptom scales represent more symptoms or problems (poor quality of life). A participant was classified as improved if a decrement of 10 points or worse was observed in the change from baseline scores. A participant was classified as worsened if a 10-point or greater increase was observed in the change from baseline scores.

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab n=23 Participants Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Global Quality of Life (QoL) - Baseline	53.409 Units on a scale Standard Deviation 28.132
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Global QoL - Treatment Cycle 05	-15.625 Units on a scale Standard Deviation 24.975
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Global QoL - Treatment Cycle 06	-16.667 Units on a scale Standard Deviation 23.987
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Global QoL - Treatment Cycle 07	-23.611 Units on a scale Standard Deviation 20.012
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Global QoL - Treatment Cycle 08	-20.833 Units on a scale Standard Deviation 43.381
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Global QoL - Treatment Cycle 15	-33.333 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Physical Functioning - Treatment Cycle 11	-6.667 Units on a scale Standard Deviation 6.667
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Physical Functioning - Treatment Cycle 14	-6.667 Units on a scale Standard Deviation 9.428
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Physical Functioning - Follow Up 2	6.667 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Role Functioning - Treatment Cycle 05	-4.167 Units on a scale Standard Deviation 21.362
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Role Functioning - Treatment Cycle 07	0.000 Units on a scale Standard Deviation 21.082
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Role Functioning - Treatment Cycle 10	-11.111 Units on a scale Standard Deviation 9.623
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Role Functioning - Treatment Cycle 11	0 Units on a scale Standard Deviation 0
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Role Functioning - Treatment Cycle 12	-5.556 Units on a scale Standard Deviation 9.623
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Role Functioning - Follow Up 2	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Emotional Functioning - Baseline	76.894 Units on a scale Standard Deviation 23.561
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Emotional Functioning - Treatment Cycle 05	-5.208 Units on a scale Standard Deviation 23.544
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Emotional Functioning - Treatment Cycle 09	-13.889 Units on a scale Standard Deviation 17.347
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Emotional Functioning - Treatment Cycle 15	4.167 Units on a scale Standard Deviation 5.893
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Cognitive Functioning - Treatment Cycle 11	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Cognitive Functioning - Treatment Cycle 13	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Social Functioning - Treatment Cycle 02	-3.333 Units on a scale Standard Deviation 30.874
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Social Functioning - Treatment Cycle 03	1.042 Units on a scale Standard Deviation 25.436
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Social Functioning - Treatment Cycle 04	-1.389 Units on a scale Standard Deviation 28.831
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Social Functioning - Treatment Cycle 05	0.000 Units on a scale Standard Deviation 34.503
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Social Functioning - Treatment Cycle 07	-13.889 Units on a scale Standard Deviation 24.553
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Social Functioning - Treatment Cycle 09	-11.111 Units on a scale Standard Deviation 25.459
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Social Functioning - Treatment Cycle 10	-11.111 Units on a scale Standard Deviation 9.623
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Social Functioning - Treatment Cycle 12	-5.556 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Social Functioning - Treatment Cycle 13	16.667 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Social Functioning - Treatment Cycle 14	-8.333 Units on a scale Standard Deviation 35.355
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Social Functioning - Treatment Cycle 15	-8.333 Units on a scale Standard Deviation 35.355
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Social Functioning - Follow Up 3	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Fatigue - Baseline	34.343 Units on a scale Standard Deviation 22.979
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Fatigue - Treatment Cycle 02	3.889 Units on a scale Standard Deviation 25.814
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Fatigue - Treatment Cycle 05	8.333 Units on a scale Standard Deviation 17.568
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Fatigue - Treatment Cycle 06	9.722 Units on a scale Standard Deviation 13.849
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Fatigue - Treatment Cycle 07	9.259 Units on a scale Standard Deviation 12.989
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Fatigue - Treatment Cycle 08	16.667 Units on a scale Standard Deviation 18.257
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Fatigue - Treatment Cycle 09	14.815 Units on a scale Standard Deviation 16.973
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Fatigue - Treatment Cycle 12	7.407 Units on a scale Standard Deviation 23.130
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Fatigue - Treatment Cycle 14	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Fatigue - Treatment Cycle 15	5.556 Units on a scale Standard Deviation 7.857
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Fatigue - Follow Up	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Nausea and Vomiting - Treatment Cycle 03	3.125 Units on a scale Standard Deviation 12.500
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Nausea and Vomiting - Treatment Cycle 05	2.083 Units on a scale Standard Deviation 5.893
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Nausea and Vomiting - Treatment Cycle 07	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Nausea and Vomiting - Treatment Cycle 08	2.778 Units on a scale Standard Deviation 6.804
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Nausea and Vomiting - Treatment Cycle 10	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Nausea and Vomiting - Treatment Cycle 14	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Pain -Treatment Cycle 02	-2.500 Units on a scale Standard Deviation 23.116
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Pain -Treatment Cycle 04	-1.389 Units on a scale Standard Deviation 18.060
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Pain -Treatment Cycle 10	5.556 Units on a scale Standard Deviation 9.623
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Pain -Treatment Cycle 11	22.222 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Pain - Follow Up	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Pain - Follow Up 2	-16.667 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Dyspnoea - Baseline	25.758 Units on a scale Standard Deviation 22.845
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Dyspnoea - Treatment Cycle 02	3.333 Units on a scale Standard Deviation 30.397
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Dyspnoea - Treatment Cycle 04	2.778 Units on a scale Standard Deviation 17.164
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Dyspnoea - Treatment Cycle 05	8.333 Units on a scale Standard Deviation 15.430
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Dyspnoea - Treatment Cycle 06	12.500 Units on a scale Standard Deviation 17.252
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Dyspnoea - Treatment Cycle 08	11.111 Units on a scale Standard Deviation 17.213
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Dyspnoea - Follow Up 3	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Insomnia - Treatment Cycle 02	5.000 Units on a scale Standard Deviation 29.170
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Insomnia - Treatment Cycle 03	6.250 Units on a scale Standard Deviation 27.806
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Insomnia - Treatment Cycle 08	0.000 Units on a scale Standard Deviation 29.814
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Insomnia - Treatment Cycle 10	11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Insomnia - Follow Up 3	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Appetite Loss - Treatment Cycle 02	-1.667 Units on a scale Standard Deviation 29.568
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Appetite Loss - Treatment Cycle 13	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Appetite Loss - Follow Up	33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Appetite Loss - Follow Up 2	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Constipation - Baseline	15.152 Units on a scale Standard Deviation 16.988
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Constipation - Treatment Cycle 04	-5.556 Units on a scale Standard Deviation 12.975
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Constipation - Treatment Cycle 08	-5.556 Units on a scale Standard Deviation 13.608
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Constipation - Treatment Cycle 12	0.000 Units on a scale Standard Deviation 33.333
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Constipation - Treatment Cycle 14	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Constipation - Follow Up 3	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Diarrhoea - Treatment Cycle 09	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Diarrhoea - Treatment Cycle 11	0.000 Units on a scale Standard Deviation 33.333
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Diarrhoea - Treatment Cycle 12	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Diarrhoea - Treatment Cycle 15	16.667 Units on a scale Standard Deviation 23.570
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Diarrhoea - Follow Up 3	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Financial Difficulties - Treatment Cycle 02	-8.333 Units on a scale Standard Deviation 26.213
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Financial Difficulties - Treatment Cycle 09	-22.222 Units on a scale Standard Deviation 50.918
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Financial Difficulties - Treatment Cycle 13	-66.667 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Financial Difficulties - Follow Up 3	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Role Functioning - Follow Up 3	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Emotional Functioning - Treatment Cycle 02	-2.083 Units on a scale Standard Deviation 18.312
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Emotional Functioning - Treatment Cycle 03	-0.521 Units on a scale Standard Deviation 20.965
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Emotional Functioning - Treatment Cycle 04	0.000 Units on a scale Standard Deviation 28.868
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Emotional Functioning - Treatment Cycle 06	-4.167 Units on a scale Standard Deviation 19.920
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Emotional Functioning - Treatment Cycle 07	-12.500 Units on a scale Standard Deviation 22.822
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Emotional Functioning - Treatment Cycle 08	-8.333 Units on a scale Standard Deviation 15.811
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Emotional Functioning - Treatment Cycle 10	-16.667 Units on a scale Standard Deviation 14.434
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Emotional Functioning - Treatment Cycle 11	-19.444 Units on a scale Standard Deviation 26.788
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Emotional Functioning - Treatment Cycle 12	-2.778 Units on a scale Standard Deviation 12.729
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Emotional Functioning - Treatment Cycle 13	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Emotional Functioning - Treatment Cycle 14	4.167 Units on a scale Standard Deviation 5.893
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Emotional Functioning - Follow Up	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Emotional Functioning - Follow Up 2	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Emotional Functioning - Follow Up 3	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Cognitive Functioning - Baseline	79.545 Units on a scale Standard Deviation 17.006
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Cognitive Functioning - Treatment Cycle 02	1.667 Units on a scale Standard Deviation 17.014
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Cognitive Functioning - Treatment Cycle 03	-2.083 Units on a scale Standard Deviation 14.751
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Cognitive Functioning - Treatment Cycle 04	1.389 Units on a scale Standard Deviation 15.006
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Cognitive Functioning - Treatment Cycle 05	-8.333 Units on a scale Standard Deviation 17.817
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Cognitive Functioning - Treatment Cycle 06	2.083 Units on a scale Standard Deviation 13.909
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Cognitive Functioning - Treatment Cycle 07	-16.667 Units on a scale Standard Deviation 25.820
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Cognitive Functioning - Treatment Cycle 08	-11.111 Units on a scale Standard Deviation 17.213
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Cognitive Functioning - Treatment Cycle 09	-5.556 Units on a scale Standard Deviation 9.623
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Cognitive Functioning - Treatment Cycle 10	5.556 Units on a scale Standard Deviation 9.623
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Cognitive Functioning - Treatment Cycle 12	-5.556 Units on a scale Standard Deviation 9.623
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Cognitive Functioning - Treatment Cycle 14	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Cognitive Functioning - Treatment Cycle 15	-8.333 Units on a scale Standard Deviation 11.785
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Cognitive Functioning - Follow Up	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Cognitive Functioning - Follow Up 2	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Cognitive Functioning - Follow Up 3	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Social Functioning - Baseline	67.424 Units on a scale Standard Deviation 28.857
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Global QoL - Treatment Cycle 02	0.833 Units on a scale Standard Deviation 28.855
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Global QoL - Treatment Cycle 03	-0.521 Units on a scale Standard Deviation 27.465
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Global QoL - Treatment Cycle 04	-6.250 Units on a scale Standard Deviation 28.007
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Global QoL - Treatment Cycle 09	-36.111 Units on a scale Standard Deviation 4.811
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Global QoL - Treatment Cycle 10	-22.222 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Global QoL - Treatment Cycle 11	-30.556 Units on a scale Standard Deviation 4.811
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Global QoL - Treatment Cycle 12	-27.778 Units on a scale Standard Deviation 9.623
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Global QoL - Treatment Cycle 13	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Global QoL - Treatment Cycle 14	-25.000 Units on a scale Standard Deviation 11.785
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Global QoL - Follow Up	-16.667 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Global QoL - Follow Up 2	-16.667 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Global QoL - Follow Up 3	-25.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Physical Functioning - Baseline	79.091 Units on a scale Standard Deviation 15.437
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Physical Functioning - Treatment Cycle 02	-5.667 Units on a scale Standard Deviation 20.207
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Physical Functioning - Treatment Cycle 03	-4.167 Units on a scale Standard Deviation 15.490
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Physical Functioning - Treatment Cycle 04	-0.556 Units on a scale Standard Deviation 11.177
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Physical Functioning - Treatment Cycle 05	-1.667 Units on a scale Standard Deviation 14.584
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Physical Functioning - Treatment Cycle 06	-0.833 Units on a scale Standard Deviation 10.947
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Physical Functioning - Treatment Cycle 07	-6.667 Units on a scale Standard Deviation 10.328
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Physical Functioning - Treatment Cycle 08	-8.889 Units on a scale Standard Deviation 10.037
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Physical Functioning - Treatment Cycle 09	-15.556 Units on a scale Standard Deviation 16.777
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Physical Functioning - Treatment Cycle 10	-6.667 Units on a scale Standard Deviation 6.667
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Physical Functioning - Treatment Cycle 12	-13.333 Units on a scale Standard Deviation 17.638
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Physical Functioning - Treatment Cycle 13	-6.667 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Social Functioning - Treatment Cycle 06	2.083 Units on a scale Standard Deviation 32.657
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Social Functioning - Treatment Cycle 08	-11.111 Units on a scale Standard Deviation 25.092
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Social Functioning - Treatment Cycle 11	-11.111 Units on a scale Standard Deviation 9.623
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Physical Functioning - Treatment Cycle 15	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Physical Functioning - Follow Up	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Social Functioning - Follow Up	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Physical Functioning - Follow Up 3	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Social Functioning - Follow Up 2	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Role Functioning - Baseline	81.061 Units on a scale Standard Deviation 22.593
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Role Functioning - Treatment Cycle 02	-7.500 Units on a scale Standard Deviation 32.307
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Role Functioning - Treatment Cycle 03	-7.292 Units on a scale Standard Deviation 28.525
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Role Functioning - Treatment Cycle 04	-4.167 Units on a scale Standard Deviation 14.434
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Role Functioning - Treatment Cycle 06	-4.167 Units on a scale Standard Deviation 14.773
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Role Functioning - Treatment Cycle 08	-8.333 Units on a scale Standard Deviation 25.276
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Fatigue - Treatment Cycle 03	8.333 Units on a scale Standard Deviation 20.488
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Fatigue - Treatment Cycle 04	5.556 Units on a scale Standard Deviation 24.845
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Fatigue - Treatment Cycle 10	14.815 Units on a scale Standard Deviation 16.973
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Fatigue - Treatment Cycle 11	18.519 Units on a scale Standard Deviation 32.075
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Fatigue - Treatment Cycle 13	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Fatigue - Follow Up 2	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Fatigue - Follow Up 3	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Role Functioning - Treatment Cycle 09	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Nausea and Vomiting - Baseline	6.818 Units on a scale Standard Deviation 15.985
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Nausea and Vomiting - Treatment Cycle 02	2.500 Units on a scale Standard Deviation 9.786
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Nausea and Vomiting - Treatment Cycle 04	0.000 Units on a scale Standard Deviation 7.107
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Nausea and Vomiting - Treatment Cycle 06	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Nausea and Vomiting - Treatment Cycle 09	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Nausea and Vomiting - Treatment Cycle 11	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Nausea and Vomiting - Treatment Cycle 12	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Nausea and Vomiting - Treatment Cycle 13	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Nausea and Vomiting - Treatment Cycle 15	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Nausea and Vomiting - Follow Up	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Nausea and Vomiting - Follow Up 2	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Nausea and Vomiting - Follow Up 3	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Pain - Baseline	31.061 Units on a scale Standard Deviation 24.286
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Pain -Treatment Cycle 03	-4.167 Units on a scale Standard Deviation 21.517
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Pain -Treatment Cycle 05	6.250 Units on a scale Standard Deviation 23.465
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Pain -Treatment Cycle 06	4.167 Units on a scale Standard Deviation 24.801
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Pain -Treatment Cycle 07	5.556 Units on a scale Standard Deviation 17.213
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Pain -Treatment Cycle 08	16.667 Units on a scale Standard Deviation 29.814
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Pain -Treatment Cycle 09	27.778 Units on a scale Standard Deviation 34.694
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Pain -Treatment Cycle 12	11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Pain -Treatment Cycle 13	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Pain -Treatment Cycle 14	8.333 Units on a scale Standard Deviation 11.785
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Pain -Treatment Cycle 15	16.667 Units on a scale Standard Deviation 23.570
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Pain - Follow Up 3	-16.667 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Dyspnoea - Treatment Cycle 03	6.250 Units on a scale Standard Deviation 21.837
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Dyspnoea - Treatment Cycle 07	5.556 Units on a scale Standard Deviation 13.608
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Dyspnoea - Treatment Cycle 09	33.333 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Dyspnoea - Treatment Cycle 10	11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Dyspnoea - Treatment Cycle 11	11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Dyspnoea - Treatment Cycle 12	11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Dyspnoea - Treatment Cycle 13	33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Dyspnoea - Treatment Cycle 14	16.667 Units on a scale Standard Deviation 23.570
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Dyspnoea - Treatment Cycle 15	16.667 Units on a scale Standard Deviation 23.570
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Dyspnoea - Follow Up	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Dyspnoea - Follow Up 2	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Insomnia - Baseline	27.273 Units on a scale Standard Deviation 22.150
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Insomnia - Treatment Cycle 04	0.000 Units on a scale Standard Deviation 24.618
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Insomnia - Treatment Cycle 05	4.167 Units on a scale Standard Deviation 27.817
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Insomnia - Treatment Cycle 06	8.333 Units on a scale Standard Deviation 29.547
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Insomnia - Treatment Cycle 07	5.556 Units on a scale Standard Deviation 25.092
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Insomnia - Treatment Cycle 09	11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Insomnia - Treatment Cycle 11	22.222 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Insomnia - Treatment Cycle 12	11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Insomnia - Treatment Cycle 13	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Insomnia - Treatment Cycle 14	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Insomnia - Treatment Cycle 15	16.667 Units on a scale Standard Deviation 23.570
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Insomnia - Follow Up	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Insomnia - Follow Up 2	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Appetite Loss - Baseline	27.273 Units on a scale Standard Deviation 24.422
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Appetite Loss - Treatment Cycle 03	-6.250 Units on a scale Standard Deviation 27.806
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Appetite Loss - Treatment Cycle 04	2.778 Units on a scale Standard Deviation 22.285
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Appetite Loss - Treatment Cycle 05	4.167 Units on a scale Standard Deviation 21.362
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Appetite Loss - Treatment Cycle 06	4.167 Units on a scale Standard Deviation 21.362
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Appetite Loss - Treatment Cycle 07	-5.556 Units on a scale Standard Deviation 13.608
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Appetite Loss - Treatment Cycle 08	0.000 Units on a scale Standard Deviation 21.082
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Appetite Loss - Treatment Cycle 09	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Appetite Loss - Treatment Cycle 10	0.000 Units on a scale Standard Deviation 33.333
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Appetite Loss - Treatment Cycle 11	11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Appetite Loss - Treatment Cycle 12	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Appetite Loss - Treatment Cycle 14	16.667 Units on a scale Standard Deviation 23.570
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Appetite Loss - Treatment Cycle 15	16.667 Units on a scale Standard Deviation 23.570
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Appetite Loss - Follow Up 3	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Constipation - Treatment Cycle 02	-3.333 Units on a scale Standard Deviation 23.939
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Constipation - Treatment Cycle 03	6.250 Units on a scale Standard Deviation 30.353
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Constipation - Treatment Cycle 05	-4.167 Units on a scale Standard Deviation 21.362
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Constipation - Treatment Cycle 06	-8.333 Units on a scale Standard Deviation 15.430
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Constipation - Treatment Cycle 07	-5.556 Units on a scale Standard Deviation 13.608
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Constipation - Treatment Cycle 09	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Constipation - Treatment Cycle 10	0.000 Units on a scale Standard Deviation 33.333
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Constipation - Treatment Cycle 11	11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Constipation - Treatment Cycle 13	33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Constipation - Treatment Cycle 15	16.667 Units on a scale Standard Deviation 23.570
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Constipation - Follow Up	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Constipation - Follow Up 2	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Diarrhoea - Baseline	9.091 Units on a scale Standard Deviation 18.349
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Diarrhoea - Treatment Cycle 02	-3.333 Units on a scale Standard Deviation 18.417
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Diarrhoea - Treatment Cycle 03	-4.167 Units on a scale Standard Deviation 20.638
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Diarrhoea - Treatment Cycle 04	-8.333 Units on a scale Standard Deviation 20.719
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Diarrhoea - Treatment Cycle 05	-4.167 Units on a scale Standard Deviation 11.785
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Diarrhoea - Treatment Cycle 06	-4.167 Units on a scale Standard Deviation 11.785
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Diarrhoea - Treatment Cycle 07	-5.556 Units on a scale Standard Deviation 13.608
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Diarrhoea - Treatment Cycle 08	0.000 Units on a scale Standard Deviation 21.082
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Diarrhoea - Treatment Cycle 10	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Diarrhoea - Treatment Cycle 13	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Diarrhoea - Treatment Cycle 14	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Diarrhoea - Follow Up	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Diarrhoea - Follow Up 2	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Financial Difficulties - Baseline	60.606 Units on a scale Standard Deviation 33.549
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Financial Difficulties - Treatment Cycle 03	-10.417 Units on a scale Standard Deviation 26.440
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Financial Difficulties - Treatment Cycle 04	-11.111 Units on a scale Standard Deviation 25.950
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Financial Difficulties - Treatment Cycle 05	-16.667 Units on a scale Standard Deviation 25.198
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Financial Difficulties - Treatment Cycle 06	-33.333 Units on a scale Standard Deviation 30.861
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Financial Difficulties - Treatment Cycle 07	-27.778 Units on a scale Standard Deviation 32.773
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Financial Difficulties - Treatment Cycle 08	-22.222 Units on a scale Standard Deviation 40.369
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Financial Difficulties - Treatment Cycle 10	-22.222 Units on a scale Standard Deviation 50.918
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Financial Difficulties - Treatment Cycle 11	-11.111 Units on a scale Standard Deviation 50.918
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Financial Difficulties - Treatment Cycle 12	-11.111 Units on a scale Standard Deviation 50.918
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Financial Difficulties - Treatment Cycle 14	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Financial Difficulties - Treatment Cycle 15	-16.667 Units on a scale Standard Deviation 23.570
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Financial Difficulties - Follow Up	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Financial Difficulties - Follow Up 2	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Role Functioning - Treatment Cycle 13	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Role Functioning - Treatment Cycle 14	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Role Functioning - Treatment Cycle 15	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status Role Functioning - Follow Up	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.

SECONDARY outcome

Timeframe: Baseline up to approximately 1 year

The EORTC QLQ-LC13 is a specific module for lung cancer. It consists of 13 items covering lung cancer symptoms (dyspnoea, coughing, hemoptysis, pain in chest, pain in arm or shoulder and pain in other parts) and the side effects of chemo- and radiotherapy (alopecia, peripheral neuropathy, sore mouth, and dysphagia), which are divided into 10 fields, all are symptom types. All EORTC symptom scores are linearly transformed so that each score has a range of 0-100. A participant was classified as improved if a decrement of 10 points or worse was observed in the change from baseline scores. A participant was classified as worsened if a 10-point or greater increase was observed in the change from baseline scores.

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab n=23 Participants Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Change From Baseline in Lung Cancer Related Symptoms Pain in other parts - Treatment Cycle 02	-3.333 Units on a scale Standard Deviation 23.939
Change From Baseline in Lung Cancer Related Symptoms Dyspnoea - Treatment Cycle 02	-5.556 Units on a scale Standard Deviation 18.557
Change From Baseline in Lung Cancer Related Symptoms Dyspnoea - Treatment Cycle 07	0.000 Units on a scale Standard Deviation 14.055
Change From Baseline in Lung Cancer Related Symptoms Dyspnoea - Treatment Cycle 08	0.000 Units on a scale Standard Deviation 22.222
Change From Baseline in Lung Cancer Related Symptoms Coughing - Treatment Cycle 11	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Coughing - Treatment Cycle 15	0.000 Units on a scale Standard Deviation 0.00
Change From Baseline in Lung Cancer Related Symptoms Hemoptysis - Baseline	4.545 Units on a scale Standard Deviation 15.585
Change From Baseline in Lung Cancer Related Symptoms Hemoptysis - Treatment Cycle 02	-1.667 Units on a scale Standard Deviation 13.134
Change From Baseline in Lung Cancer Related Symptoms Hemoptysis - Treatment Cycle 03	-2.083 Units on a scale Standard Deviation 8.333
Change From Baseline in Lung Cancer Related Symptoms Hemoptysis - Treatment Cycle 06	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Hemoptysis - Treatment Cycle 07	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Hemoptysis - Treatment Cycle 15	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Hemoptysis - Follow Up	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Hemoptysis - Follow Up 2	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Hemoptysis - Follow Up 3	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Sore mouth - Treatment Cycle 11	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Sore mouth - Follow Up	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Sore mouth - Follow Up 2	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Dysphagia - Treatment Cycle 03	0.000 Units on a scale Standard Deviation 12.172
Change From Baseline in Lung Cancer Related Symptoms Dysphagia - Treatment Cycle 06	-8.333 Units on a scale Standard Deviation 15.430
Change From Baseline in Lung Cancer Related Symptoms Dysphagia - Treatment Cycle 09	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Dysphagia - Treatment Cycle 14	-16.667 Units on a scale Standard Deviation 23.570
Change From Baseline in Lung Cancer Related Symptoms Dysphagia - Follow Up 2	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Peripheral neuropathy - Treatment Cycle 04	8.333 Units on a scale Standard Deviation 15.076
Change From Baseline in Lung Cancer Related Symptoms Peripheral neuropathy - Treatment Cycle 09	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Peripheral neuropathy - Treatment Cycle 14	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Peripheral neuropathy - Follow Up 3	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Alopecia - Treatment Cycle 07	-5.556 Units on a scale Standard Deviation 25.092
Change From Baseline in Lung Cancer Related Symptoms Alopecia - Treatment Cycle 08	-5.556 Units on a scale Standard Deviation 25.092
Change From Baseline in Lung Cancer Related Symptoms Alopecia - Treatment Cycle 10	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Alopecia - Treatment Cycle 11	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Alopecia - Treatment Cycle 12	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Alopecia - Treatment Cycle 13	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Alopecia - Treatment Cycle 14	-16.667 Units on a scale Standard Deviation 23.570
Change From Baseline in Lung Cancer Related Symptoms Alopecia - Treatment Cycle 15	-16.667 Units on a scale Standard Deviation 23.570
Change From Baseline in Lung Cancer Related Symptoms Alopecia - Follow Up	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Alopecia - Follow Up 2	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Alopecia - Follow Up 3	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Pain in chest - Treatment Cycle 06	0.000 Units on a scale Standard Deviation 25.198
Change From Baseline in Lung Cancer Related Symptoms Pain in chest - Treatment Cycle 09	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Pain in chest - Treatment Cycle 12	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Pain in chest - Treatment Cycle 13	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Pain in chest - Treatment Cycle 14	-16.667 Units on a scale Standard Deviation 23.570
Change From Baseline in Lung Cancer Related Symptoms Pain in arm or shoulder -Baseline	22 Units on a scale Standard Deviation 27.273
Change From Baseline in Lung Cancer Related Symptoms Pain in arm or shoulder -Treatment Cycle 06	-4.167 Units on a scale Standard Deviation 41.547
Change From Baseline in Lung Cancer Related Symptoms Pain in arm or shoulder -Treatment Cycle 07	5.556 Units on a scale Standard Deviation 25.092
Change From Baseline in Lung Cancer Related Symptoms Pain in arm or shoulder -Treatment Cycle 12	11.111 Units on a scale Standard Deviation 50.918
Change From Baseline in Lung Cancer Related Symptoms Pain in arm or shoulder -Treatment Cycle 13	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Pain in arm or shoulder -Treatment Cycle 14	50.000 Units on a scale Standard Deviation 70.711
Change From Baseline in Lung Cancer Related Symptoms Pain in other parts - Treatment Cycle 03	-2.083 Units on a scale Standard Deviation 22.669
Change From Baseline in Lung Cancer Related Symptoms Pain in other parts - Treatment Cycle 04	2.778 Units on a scale Standard Deviation 22.285
Change From Baseline in Lung Cancer Related Symptoms Pain in other parts - Treatment Cycle 07	-5.556 Units on a scale Standard Deviation 25.092
Change From Baseline in Lung Cancer Related Symptoms Pain in other parts - Treatment Cycle 08	5.556 Units on a scale Standard Deviation 32.773
Change From Baseline in Lung Cancer Related Symptoms Pain in other parts - Treatment Cycle 11	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Pain in other parts - Follow Up	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Pain in other parts - Follow Up 2	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Dyspnoea - Baseline	34.343 Units on a scale Standard Deviation 20.260
Change From Baseline in Lung Cancer Related Symptoms Dyspnoea - Treatment Cycle 03	-2.778 Units on a scale Standard Deviation 20.488
Change From Baseline in Lung Cancer Related Symptoms Dyspnoea - Treatment Cycle 04	-4.630 Units on a scale Standard Deviation 16.723
Change From Baseline in Lung Cancer Related Symptoms Dyspnoea - Treatment Cycle 05	-2.778 Units on a scale Standard Deviation 19.473
Change From Baseline in Lung Cancer Related Symptoms Dyspnoea - Treatment Cycle 06	5.556 Units on a scale Standard Deviation 16.798
Change From Baseline in Lung Cancer Related Symptoms Dyspnoea - Treatment Cycle 09	11.111 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Dyspnoea - Treatment Cycle 10	7.407 Units on a scale Standard Deviation 16.973
Change From Baseline in Lung Cancer Related Symptoms Dyspnoea - Treatment Cycle 11	7.407 Units on a scale Standard Deviation 6.415
Change From Baseline in Lung Cancer Related Symptoms Dyspnoea - Treatment Cycle 12	7.407 Units on a scale Standard Deviation 16.973
Change From Baseline in Lung Cancer Related Symptoms Dyspnoea - Treatment Cycle 13	11.111 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Dyspnoea - Follow Up	-22.222 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Dyspnoea - Follow Up 2	-22.222 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Dyspnoea - Follow Up 3	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Coughing - Baseline	37.879 Units on a scale Standard Deviation 31.363
Change From Baseline in Lung Cancer Related Symptoms Coughing - Treatment Cycle 02	1.667 Units on a scale Standard Deviation 25.305
Change From Baseline in Lung Cancer Related Symptoms Coughing - Treatment Cycle 03	10.417 Units on a scale Standard Deviation 23.472
Change From Baseline in Lung Cancer Related Symptoms Coughing - Treatment Cycle 04	0.000 Units on a scale Standard Deviation 14.213
Change From Baseline in Lung Cancer Related Symptoms Coughing - Treatment Cycle 05	4.167 Units on a scale Standard Deviation 21.362
Change From Baseline in Lung Cancer Related Symptoms Coughing - Treatment Cycle 06	16.667 Units on a scale Standard Deviation 30.861
Change From Baseline in Lung Cancer Related Symptoms Coughing - Treatment Cycle 07	0.000 Units on a scale Standard Deviation 21.082
Change From Baseline in Lung Cancer Related Symptoms Coughing - Treatment Cycle 08	11.111 Units on a scale Standard Deviation 34.427
Change From Baseline in Lung Cancer Related Symptoms Coughing - Treatment Cycle 09	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Coughing - Treatment Cycle 10	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Coughing - Treatment Cycle 12	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Coughing - Treatment Cycle 13	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Coughing - Treatment Cycle 14	0.000 Units on a scale Standard Deviation 47.140
Change From Baseline in Lung Cancer Related Symptoms Coughing - Follow Up	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Coughing - Follow Up 2	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Coughing - Follow Up 3	-66.667 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Hemoptysis - Treatment Cycle 04	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Hemoptysis - Treatment Cycle 05	-4.167 Units on a scale Standard Deviation 11.785
Change From Baseline in Lung Cancer Related Symptoms Hemoptysis - Treatment Cycle 08	11.111 Units on a scale Standard Deviation 27.217
Change From Baseline in Lung Cancer Related Symptoms Hemoptysis - Treatment Cycle 09	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Hemoptysis - Treatment Cycle 10	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Hemoptysis - Treatment Cycle 11	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Hemoptysis - Treatment Cycle 12	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Hemoptysis - Treatment Cycle 13	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Hemoptysis - Treatment Cycle 14	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Sore mouth - Baseline	3.030 Units on a scale Standard Deviation 9.808
Change From Baseline in Lung Cancer Related Symptoms Sore mouth - Treatment Cycle 02	6.667 Units on a scale Standard Deviation 20.520
Change From Baseline in Lung Cancer Related Symptoms Sore mouth - Treatment Cycle 03	4.167 Units on a scale Standard Deviation 20.638
Change From Baseline in Lung Cancer Related Symptoms Sore mouth - Treatment Cycle 04	0.000 Units on a scale Standard Deviation 20.101
Change From Baseline in Lung Cancer Related Symptoms Sore mouth - Treatment Cycle 05	4.167 Units on a scale Standard Deviation 11.785
Change From Baseline in Lung Cancer Related Symptoms Sore mouth - Treatment Cycle 06	-4.167 Units on a scale Standard Deviation 11.785
Change From Baseline in Lung Cancer Related Symptoms Sore mouth - Treatment Cycle 07	5.556 Units on a scale Standard Deviation 13.608
Change From Baseline in Lung Cancer Related Symptoms Sore mouth - Treatment Cycle 08	5.556 Units on a scale Standard Deviation 13.608
Change From Baseline in Lung Cancer Related Symptoms Sore mouth - Treatment Cycle 09	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Sore mouth - Treatment Cycle 10	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Sore mouth - Treatment Cycle 12	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Sore mouth - Treatment Cycle 13	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Sore mouth - Treatment Cycle 14	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Sore mouth - Treatment Cycle 15	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Sore mouth - Follow Up 3	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Dysphagia - Baseline	10.606 Units on a scale Standard Deviation 15.891
Change From Baseline in Lung Cancer Related Symptoms Dysphagia - Treatment Cycle 02	5.000 Units on a scale Standard Deviation 24.839
Change From Baseline in Lung Cancer Related Symptoms Dysphagia - Treatment Cycle 04	-2.778 Units on a scale Standard Deviation 9.623
Change From Baseline in Lung Cancer Related Symptoms Dysphagia - Treatment Cycle 05	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Dysphagia - Treatment Cycle 07	-5.556 Units on a scale Standard Deviation 13.608
Change From Baseline in Lung Cancer Related Symptoms Dysphagia - Treatment Cycle 08	-5.556 Units on a scale Standard Deviation 13.608
Change From Baseline in Lung Cancer Related Symptoms Dysphagia - Treatment Cycle 10	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Dysphagia - Treatment Cycle 11	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Dysphagia - Treatment Cycle 12	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Dysphagia - Treatment Cycle 13	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Dysphagia - Treatment Cycle 15	-16.667 Units on a scale Standard Deviation 23.570
Change From Baseline in Lung Cancer Related Symptoms Dysphagia - Follow Up	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Dysphagia - Follow Up 3	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Peripheral neuropathy - Baseline	9.091 Units on a scale Standard Deviation 18.349
Change From Baseline in Lung Cancer Related Symptoms Peripheral neuropathy - Treatment Cycle 02	6.5667 Units on a scale Standard Deviation 23.195
Change From Baseline in Lung Cancer Related Symptoms Peripheral neuropathy - Treatment Cycle 03	4.167 Units on a scale Standard Deviation 16.667
Change From Baseline in Lung Cancer Related Symptoms Peripheral neuropathy - Treatment Cycle 05	12.500 Units on a scale Standard Deviation 17.252
Change From Baseline in Lung Cancer Related Symptoms Peripheral neuropathy - Treatment Cycle 06	12.500 Units on a scale Standard Deviation 17.252
Change From Baseline in Lung Cancer Related Symptoms Peripheral neuropathy - Treatment Cycle 07	11.111 Units on a scale Standard Deviation 17.213
Change From Baseline in Lung Cancer Related Symptoms Peripheral neuropathy - Treatment Cycle 08	11.111 Units on a scale Standard Deviation 17.213
Change From Baseline in Lung Cancer Related Symptoms Peripheral neuropathy - Treatment Cycle 10	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Peripheral neuropathy - Treatment Cycle 11	11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Peripheral neuropathy - Treatment Cycle 12	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Peripheral neuropathy - Treatment Cycle 13	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Peripheral neuropathy - Treatment Cycle 15	0.000 Units on a scale Standard Deviation 0.000
Change From Baseline in Lung Cancer Related Symptoms Peripheral neuropathy - Follow Up	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Peripheral neuropathy - Follow Up 2	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Alopecia -Baseline	16.667 Units on a scale Standard Deviation 26.726
Change From Baseline in Lung Cancer Related Symptoms Alopecia - Treatment Cycle 02	-3.333 Units on a scale Standard Deviation 18.417
Change From Baseline in Lung Cancer Related Symptoms Alopecia - Treatment Cycle 03	-12.500 Units on a scale Standard Deviation 29.502
Change From Baseline in Lung Cancer Related Symptoms Alopecia - Treatment Cycle 04	-13.889 Units on a scale Standard Deviation 22.285
Change From Baseline in Lung Cancer Related Symptoms Alopecia - Treatment Cycle 05	-8.333 Units on a scale Standard Deviation 23.570
Change From Baseline in Lung Cancer Related Symptoms Alopecia - Treatment Cycle 06	-12.500 Units on a scale Standard Deviation 24.801
Change From Baseline in Lung Cancer Related Symptoms Alopecia - Treatment Cycle 09	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Pain in chest - Baseline	31.818 Units on a scale Standard Deviation 29.951
Change From Baseline in Lung Cancer Related Symptoms Pain in chest - Treatment Cycle 02	1.667 Units on a scale Standard Deviation 29.568
Change From Baseline in Lung Cancer Related Symptoms Pain in chest - Treatment Cycle 03	0.000 Units on a scale Standard Deviation 29.814
Change From Baseline in Lung Cancer Related Symptoms Pain in chest - Treatment Cycle 04	2.778 Units on a scale Standard Deviation 22.285
Change From Baseline in Lung Cancer Related Symptoms Pain in chest - Treatment Cycle 05	4.167 Units on a scale Standard Deviation 33.034
Change From Baseline in Lung Cancer Related Symptoms Pain in chest - Treatment Cycle 07	5.556 Units on a scale Standard Deviation 32.773
Change From Baseline in Lung Cancer Related Symptoms Pain in chest - Treatment Cycle 08	-5.556 Units on a scale Standard Deviation 25.092
Change From Baseline in Lung Cancer Related Symptoms Pain in chest - Treatment Cycle 10	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Pain in chest - Treatment Cycle 11	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Pain in chest - Treatment Cycle 15	-16.667 Units on a scale Standard Deviation 23.570
Change From Baseline in Lung Cancer Related Symptoms Pain in chest - Follow Up	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Pain in chest - Follow Up 2	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Pain in chest - Follow Up 3	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Pain in arm or shoulder -Treatment Cycle 02	-6.667 Units on a scale Standard Deviation 31.715
Change From Baseline in Lung Cancer Related Symptoms Pain in arm or shoulder -Treatment Cycle 03	-12.500 Units on a scale Standard Deviation 36.260
Change From Baseline in Lung Cancer Related Symptoms Pain in arm or shoulder -Treatment Cycle 04	-8.333 Units on a scale Standard Deviation 35.176
Change From Baseline in Lung Cancer Related Symptoms Pain in arm or shoulder -Treatment Cycle 05	-4.167 Units on a scale Standard Deviation 45.207
Change From Baseline in Lung Cancer Related Symptoms Pain in arm or shoulder -Treatment Cycle 08	22.222 Units on a scale Standard Deviation 40.369
Change From Baseline in Lung Cancer Related Symptoms Pain in arm or shoulder -Treatment Cycle 09	33.333 Units on a scale Standard Deviation 57.735
Change From Baseline in Lung Cancer Related Symptoms Pain in arm or shoulder -Treatment Cycle 10	11.111 Units on a scale Standard Deviation 50.918
Change From Baseline in Lung Cancer Related Symptoms Pain in arm or shoulder -Treatment Cycle 11	11.111 Units on a scale Standard Deviation 50.918
Change From Baseline in Lung Cancer Related Symptoms Pain in arm or shoulder -Treatment Cycle 15	16.667 Units on a scale Standard Deviation 23.570
Change From Baseline in Lung Cancer Related Symptoms Pain in arm or shoulder - Follow Up	33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Pain in arm or shoulder - Follow Up 2	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Pain in arm or shoulder - Follow Up 3	33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Pain in other parts - Baseline	25.758 Units on a scale Standard Deviation 28.971
Change From Baseline in Lung Cancer Related Symptoms Pain in other parts - Treatment Cycle 05	16.667 Units on a scale Standard Deviation 25.198
Change From Baseline in Lung Cancer Related Symptoms Pain in other parts - Treatment Cycle 06	-4.167 Units on a scale Standard Deviation 21.362
Change From Baseline in Lung Cancer Related Symptoms Pain in other parts - Treatment Cycle 09	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Pain in other parts - Treatment Cycle 10	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Pain in other parts - Treatment Cycle 12	-11.111 Units on a scale Standard Deviation 19.245
Change From Baseline in Lung Cancer Related Symptoms Pain in other parts - Treatment Cycle 13	0.000 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.
Change From Baseline in Lung Cancer Related Symptoms Pain in other parts - Treatment Cycle 14	-16.667 Units on a scale Standard Deviation 23.570
Change From Baseline in Lung Cancer Related Symptoms Pain in other parts - Treatment Cycle 15	-16.667 Units on a scale Standard Deviation 23.570
Change From Baseline in Lung Cancer Related Symptoms Pain in other parts - Follow Up 3	-33.333 Units on a scale Standard Deviation NA NA = Standard deviation couldn't be calculated from the data of one participant.

Adverse Events

Atezolizumab Plus Bevacizumab

Serious events: 4 serious events

Other events: 23 other events

Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure	Atezolizumab Plus Bevacizumab n=23 participants at risk Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
General disorders Death	4.3% 1/23 • Number of events 1 • Baseline up to approximately 2.5 years
General disorders Malaise	4.3% 1/23 • Number of events 1 • Baseline up to approximately 2.5 years
Cardiac disorders Left ventricular dysfunction	4.3% 1/23 • Number of events 1 • Baseline up to approximately 2.5 years
Infections and infestations Gastroenteritis	4.3% 1/23 • Number of events 1 • Baseline up to approximately 2.5 years
Infections and infestations Pneumonia	4.3% 1/23 • Number of events 1 • Baseline up to approximately 2.5 years
Infections and infestations Upper respiratory tract infection	4.3% 1/23 • Number of events 1 • Baseline up to approximately 2.5 years
Investigations Platelet count decreased	4.3% 1/23 • Number of events 1 • Baseline up to approximately 2.5 years

Other adverse events

Other adverse events
Measure	Atezolizumab Plus Bevacizumab n=23 participants at risk Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
Blood and lymphatic system disorders Anaemia	21.7% 5/23 • Number of events 7 • Baseline up to approximately 2.5 years
Blood and lymphatic system disorders Leukocytosis	8.7% 2/23 • Number of events 2 • Baseline up to approximately 2.5 years
Cardiac disorders Sinus tachycardia	8.7% 2/23 • Number of events 2 • Baseline up to approximately 2.5 years
Endocrine disorders Hypothyroidism	17.4% 4/23 • Number of events 4 • Baseline up to approximately 2.5 years
Gastrointestinal disorders Diarrhoea	13.0% 3/23 • Number of events 3 • Baseline up to approximately 2.5 years
Gastrointestinal disorders Vomiting	8.7% 2/23 • Number of events 2 • Baseline up to approximately 2.5 years
Gastrointestinal disorders Constipation	13.0% 3/23 • Number of events 3 • Baseline up to approximately 2.5 years
General disorders Fatigue	26.1% 6/23 • Number of events 6 • Baseline up to approximately 2.5 years
Infections and infestations Upper respiratory tract infection	13.0% 3/23 • Number of events 3 • Baseline up to approximately 2.5 years
Infections and infestations Urinary tract infection	21.7% 5/23 • Number of events 7 • Baseline up to approximately 2.5 years
Investigations Alanine aminotransferase increased	17.4% 4/23 • Number of events 5 • Baseline up to approximately 2.5 years
Investigations Aspartate aminotransferase increased	26.1% 6/23 • Number of events 10 • Baseline up to approximately 2.5 years
Investigations Blood thyroid stimulating hormone increased	21.7% 5/23 • Number of events 5 • Baseline up to approximately 2.5 years
Investigations Platelet count decreased	21.7% 5/23 • Number of events 10 • Baseline up to approximately 2.5 years
Investigations Blood bilirubin increased	8.7% 2/23 • Number of events 2 • Baseline up to approximately 2.5 years
Investigations Blood creatine phosphokinase increased	8.7% 2/23 • Number of events 2 • Baseline up to approximately 2.5 years
Investigations Urinary occult blood positive	8.7% 2/23 • Number of events 2 • Baseline up to approximately 2.5 years
Metabolism and nutrition disorders Decreased appetite	21.7% 5/23 • Number of events 5 • Baseline up to approximately 2.5 years
Metabolism and nutrition disorders Hypercholesterolaemia	21.7% 5/23 • Number of events 6 • Baseline up to approximately 2.5 years
Metabolism and nutrition disorders Hypoalbuminaemia	21.7% 5/23 • Number of events 10 • Baseline up to approximately 2.5 years
Metabolism and nutrition disorders Hyperglycaemia	13.0% 3/23 • Number of events 6 • Baseline up to approximately 2.5 years
Metabolism and nutrition disorders Hypertriglyceridaemia	13.0% 3/23 • Number of events 4 • Baseline up to approximately 2.5 years
Metabolism and nutrition disorders Hypokalaemia	8.7% 2/23 • Number of events 3 • Baseline up to approximately 2.5 years
Metabolism and nutrition disorders Hyponatraemia	8.7% 2/23 • Number of events 2 • Baseline up to approximately 2.5 years
Musculoskeletal and connective tissue disorders Back pain	8.7% 2/23 • Number of events 3 • Baseline up to approximately 2.5 years
Musculoskeletal and connective tissue disorders Muscular weakness	13.0% 3/23 • Number of events 3 • Baseline up to approximately 2.5 years
Musculoskeletal and connective tissue disorders Pain in extremity	21.7% 5/23 • Number of events 5 • Baseline up to approximately 2.5 years
Renal and urinary disorders Proteinuria	30.4% 7/23 • Number of events 10 • Baseline up to approximately 2.5 years
Respiratory, thoracic and mediastinal disorders Cough	13.0% 3/23 • Number of events 3 • Baseline up to approximately 2.5 years
Skin and subcutaneous tissue disorders Pruritus	13.0% 3/23 • Number of events 3 • Baseline up to approximately 2.5 years
Vascular disorders Hypertension	26.1% 6/23 • Number of events 7 • Baseline up to approximately 2.5 years
Investigations Weight decreased	21.7% 5/23 • Number of events 5 • Baseline up to approximately 2.5 years
Investigations Thyroxine free decreased	8.7% 2/23 • Number of events 2 • Baseline up to approximately 2.5 years
Investigations White blood cells urine positive	8.7% 2/23 • Number of events 2 • Baseline up to approximately 2.5 years

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER