Trial Outcomes & Findings for A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer (NCT NCT05171777)
NCT ID: NCT05171777
Last Updated: 2025-12-11
Results Overview
Participants preference was assessed based on the Question 1 of PPQ. Question 1 (All things considered, which route of administration did you prefer?) asks participants to report their preference for the route of administration (IV, SC, or no preference). A point estimate with associated 95% CI for the percentage of participants who preferred atezolizumab SC was calculated. Participants experiencing any of the following events: treatment withdrawal prior to eligibility for PPQ, or death without answering Question 1 of PPQ, or treatment not started; were excluded from the analysis set. Participants who answered Question 1 of the PPQ without having at least 2 consecutive administrations of treatment with each administration modality (SC and IV) were excluded from the analysis. Percentages have been rounded off. As planned, participant preference was summarized and presented by overall (all participants) and by randomized treatment sequence using FAS.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
179 participants
Primary outcome timeframe
Cycle 6 Day 1 (cycle length=21 days)
Results posted on
2025-12-11
Participant Flow
Participants took part in the study across 37 investigative sites in 12 countries (Spain, Brazil, Finland, Italy, United States, Argentina, Canada, Republic of Korea, Costa Rica, Latvia, Poland, and Chile) from 04 April 2022 to 25 October 2024.
A total of 179 participants with non-small cell lung cancer (NSCLC) were randomized in 1:1 ratio to Arm A (atezolizumab IV followed by atezolizumab SC) or Arm B (atezolizumab SC followed by atezolizumab IV). The study consists of two periods: Treatment Crossover Period, and Treatment Continuation Period.
Participant milestones
| Measure |
Crossover Atezolizumab IV/SC
Participants were administered atezolizumab, intravenous (IV) infusion, 1200 milligrams (mg), every 3 weeks (Q3W) for 3 cycles followed by atezolizumab, subcutaneous (SC) injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Continuation Atezolizumab IV
After 6 cycles of treatment in Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
Continuation Atezolizumab SC
After 6 cycles of treatment in Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Treatment Crossover Period
STARTED
|
89
|
90
|
0
|
0
|
|
Treatment Crossover Period
COMPLETED
|
55
|
60
|
0
|
0
|
|
Treatment Crossover Period
NOT COMPLETED
|
34
|
30
|
0
|
0
|
|
Treatment Continuation Period
STARTED
|
0
|
0
|
26
|
89
|
|
Treatment Continuation Period
COMPLETED
|
0
|
0
|
11
|
32
|
|
Treatment Continuation Period
NOT COMPLETED
|
0
|
0
|
15
|
57
|
Reasons for withdrawal
| Measure |
Crossover Atezolizumab IV/SC
Participants were administered atezolizumab, intravenous (IV) infusion, 1200 milligrams (mg), every 3 weeks (Q3W) for 3 cycles followed by atezolizumab, subcutaneous (SC) injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Continuation Atezolizumab IV
After 6 cycles of treatment in Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
Continuation Atezolizumab SC
After 6 cycles of treatment in Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Treatment Crossover Period
Adverse Event
|
9
|
6
|
0
|
0
|
|
Treatment Crossover Period
Death
|
5
|
5
|
0
|
0
|
|
Treatment Crossover Period
Disease Relapse
|
1
|
0
|
0
|
0
|
|
Treatment Crossover Period
Reason not Specified
|
1
|
1
|
0
|
0
|
|
Treatment Crossover Period
Physician Decision
|
0
|
1
|
0
|
0
|
|
Treatment Crossover Period
Progressive Disease
|
14
|
10
|
0
|
0
|
|
Treatment Crossover Period
Protocol Violation
|
0
|
2
|
0
|
0
|
|
Treatment Crossover Period
Symptomatic Deterioration
|
0
|
1
|
0
|
0
|
|
Treatment Crossover Period
Withdrawal by Subject
|
4
|
4
|
0
|
0
|
|
Treatment Continuation Period
Adverse Event
|
0
|
0
|
3
|
6
|
|
Treatment Continuation Period
Death
|
0
|
0
|
1
|
3
|
|
Treatment Continuation Period
Disease Relapse
|
0
|
0
|
1
|
0
|
|
Treatment Continuation Period
Lack of Efficacy
|
0
|
0
|
0
|
1
|
|
Treatment Continuation Period
Physician Decision
|
0
|
0
|
0
|
4
|
|
Treatment Continuation Period
Progressive Disease
|
0
|
0
|
6
|
20
|
|
Treatment Continuation Period
Study Ended by Sponsor
|
0
|
0
|
4
|
15
|
|
Treatment Continuation Period
Symptomatic Deterioration
|
0
|
0
|
0
|
2
|
|
Treatment Continuation Period
Withdrawal by Subject
|
0
|
0
|
0
|
6
|
Baseline Characteristics
A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Crossover Atezolizumab IV/SC
n=89 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=90 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Total
n=179 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 9.2 • n=237 Participants
|
67.7 years
STANDARD_DEVIATION 9.4 • n=243 Participants
|
67.0 years
STANDARD_DEVIATION 9.3 • n=480 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=237 Participants
|
32 Participants
n=243 Participants
|
60 Participants
n=480 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=237 Participants
|
58 Participants
n=243 Participants
|
119 Participants
n=480 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=237 Participants
|
18 Participants
n=243 Participants
|
38 Participants
n=480 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=237 Participants
|
62 Participants
n=243 Participants
|
117 Participants
n=480 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=237 Participants
|
10 Participants
n=243 Participants
|
24 Participants
n=480 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=237 Participants
|
2 Participants
n=243 Participants
|
3 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=237 Participants
|
8 Participants
n=243 Participants
|
13 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
1 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=237 Participants
|
74 Participants
n=243 Participants
|
149 Participants
n=480 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=237 Participants
|
6 Participants
n=243 Participants
|
13 Participants
n=480 Participants
|
PRIMARY outcome
Timeframe: Cycle 6 Day 1 (cycle length=21 days)Population: FAS included all randomized participants. Overall number analyzed is the number of participants who answered Question 1 of PPQ.
Participants preference was assessed based on the Question 1 of PPQ. Question 1 (All things considered, which route of administration did you prefer?) asks participants to report their preference for the route of administration (IV, SC, or no preference). A point estimate with associated 95% CI for the percentage of participants who preferred atezolizumab SC was calculated. Participants experiencing any of the following events: treatment withdrawal prior to eligibility for PPQ, or death without answering Question 1 of PPQ, or treatment not started; were excluded from the analysis set. Participants who answered Question 1 of the PPQ without having at least 2 consecutive administrations of treatment with each administration modality (SC and IV) were excluded from the analysis. Percentages have been rounded off. As planned, participant preference was summarized and presented by overall (all participants) and by randomized treatment sequence using FAS.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=60 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=63 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
n=123 Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Percentage of Participants Who Preferred Atezolizumab SC to Atezolizumab IV Assessed Using Patient Preference Questionnaire (PPQ)
|
71.67 percentage of participants
Interval 58.56 to 82.55
|
69.84 percentage of participants
Interval 56.98 to 80.77
|
70.73 percentage of participants
Interval 61.85 to 78.59
|
—
|
SECONDARY outcome
Timeframe: Cycles 3 Day 1 and Cycle 6 Day 1 (cycle length=21 days)Population: FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants who answered Question 1 of TASQ IV/SC.
TASQ is a 12-item, participant-reported questionnaire measuring the impact of each mode of treatment administration (TASQ-IV for IV treatment and TASQ-SC for SC treatment) on five domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction. TASQ-IV/-SC was administered at treatment Cycles 3 and 6 according to the order of treatment received per arm during the Crossover Period. Participants satisfaction was assessed based on the Question 1 of TASQ-IV/SC which asks participants about their satisfaction with respect to route of administration (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, participant did not answer the question). Question 1 - TASQ- IV (How satisfied or dissatisfied were you with the IV infusion?) and TASQ- SC (How satisfied or dissatisfied were you with the SC injection?)
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=74 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=71 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV)
TASQ- IV- Satisfied
|
31 Participants
|
34 Participants
|
—
|
—
|
|
Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV)
TASQ- IV- Very Dissatisfied
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV)
TASQ- IV- Participant did not Answer Question
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV)
TASQ- SC- Neither Satisfied nor Dissatisfied
|
9 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV)
TASQ- SC- Very Dissatisfied
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV)
TASQ- SC- Participant did not Answer Question
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV)
TASQ- IV- Very Satisfied
|
25 Participants
|
10 Participants
|
—
|
—
|
|
Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV)
TASQ- IV- Neither Satisfied nor Dissatisfied
|
17 Participants
|
11 Participants
|
—
|
—
|
|
Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV)
TASQ- IV- Dissatisfied
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV)
TASQ- SC- Very Satisfied
|
22 Participants
|
30 Participants
|
—
|
—
|
|
Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV)
TASQ- SC- Satisfied
|
21 Participants
|
36 Participants
|
—
|
—
|
|
Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV)
TASQ- SC- Dissatisfied
|
3 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 6 Day 1 (Cycle length=21 days)Population: FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis.
At Cycle 6, Day 1, participants were expected to select the route of study treatment administration (SC or IV) they would like to receive during the Treatment Continuation Period (starting at Cycle 7). Percentage of participants who chose SC administration have been reported here. Percentages have been rounded off.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=55 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=60 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Percentage of Participants Who Select Atezolizumab SC for Treatment Continuation Period
|
78.2 percentage of participants
|
76.7 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 1 to 6 (cycle length= 21 days)Population: Overall number analyzed included HCPs who completed Question 1 of the survey. The number analyzed included HCPs who completed Question 1 of the survey at the specified treatment cycles.
The HCPQ- Drug Preparation Area Question 1 was completed by the HCPs within the pharmacy/drug preparation area where atezolizumab IV reconstitution or atezolizumab SC was prepared before the actual drug administration took place. The HCPQs were completed for every participant at each treatment cycle (Cycles 1-6, i.e., 3 cycles of atezolizumab IV followed by 3 cycles of atezolizumab SC or vice versa) of the treatment cross-over period. HCPs responded to the following parts of Question 1 that sought to evaluate the amount of time it took to prepare the IV infusion/SC injection of atezolizumab: "How long (in minutes) did it take to prepare the treatment for use?"
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=84 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=83 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Duration of Treatment Preparation According to Healthcare Professionals (HCPs) Response to Perception of Time, Assessed Using Question 1 of Healthcare Professional Questionnaires (HCPQs) - Drug Preparation Area
Cycle 1
|
5.0 minutes
Interval 1.0 to 40.0
|
5.0 minutes
Interval 1.0 to 45.0
|
—
|
—
|
|
Duration of Treatment Preparation According to Healthcare Professionals (HCPs) Response to Perception of Time, Assessed Using Question 1 of Healthcare Professional Questionnaires (HCPQs) - Drug Preparation Area
Cycle 2
|
5.0 minutes
Interval 1.0 to 40.0
|
5.0 minutes
Interval 1.0 to 35.0
|
—
|
—
|
|
Duration of Treatment Preparation According to Healthcare Professionals (HCPs) Response to Perception of Time, Assessed Using Question 1 of Healthcare Professional Questionnaires (HCPQs) - Drug Preparation Area
Cycle 5
|
5.0 minutes
Interval 1.0 to 35.0
|
5.0 minutes
Interval 1.0 to 59.0
|
—
|
—
|
|
Duration of Treatment Preparation According to Healthcare Professionals (HCPs) Response to Perception of Time, Assessed Using Question 1 of Healthcare Professional Questionnaires (HCPQs) - Drug Preparation Area
Cycle 6
|
5.0 minutes
Interval 1.0 to 35.0
|
5.0 minutes
Interval 1.0 to 36.0
|
—
|
—
|
|
Duration of Treatment Preparation According to Healthcare Professionals (HCPs) Response to Perception of Time, Assessed Using Question 1 of Healthcare Professional Questionnaires (HCPQs) - Drug Preparation Area
Cycle 3
|
5.0 minutes
Interval 1.0 to 45.0
|
4.5 minutes
Interval 1.0 to 40.0
|
—
|
—
|
|
Duration of Treatment Preparation According to Healthcare Professionals (HCPs) Response to Perception of Time, Assessed Using Question 1 of Healthcare Professional Questionnaires (HCPQs) - Drug Preparation Area
Cycle 4
|
5.0 minutes
Interval 1.0 to 35.0
|
5.0 minutes
Interval 1.0 to 50.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 6 Day 1 (cycle length=21 days)Population: Overall number analyzed included HCPs who completed Question 2 of the survey at treatment Cycle 6. Percentages have been rounded off.
HCPs within pharmacy/drug preparation area responded to HCPQ-Drug Preparation Area Question 2 at Cycle 6 of Treatment Crossover Period for every participant: "If all IV infusions are switched to SC, please indicate how strongly you agree/disagree with each of following statements: a=Staff will have increased availability for other tasks in pharmacy; b=Administrative procedures around atezolizumab SC will require less time; c=Atezolizumab SC formulations will provide more flexibility for staff in managing their workload; d=Due to ready-to-use atezolizumab SC formulations, potential dosing errors will be avoided; e=Due to ready-to-use atezolizumab SC formulations, there will be less drug wastage; f=Without having to reconstitute the drug, less storage space for atezolizumab SC related supplies will be required in pharmacy; g=Preparation procedures \& associated time staff time commitment will be reduced, h=It will ease drug administration for participants with difficult venous access."
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=57 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=60 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
a=Strongly Disagree
|
7.0 percentage of HCPs
|
10.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
a=Disagree
|
7.0 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
a=Neutral
|
21.1 percentage of HCPs
|
31.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
a=Agree
|
24.6 percentage of HCPs
|
20.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
a=Strongly Agree
|
31.6 percentage of HCPs
|
25.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
a=Not Applicable
|
3.5 percentage of HCPs
|
1.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
b=Disagree
|
14.0 percentage of HCPs
|
8.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
b=Neutral
|
29.8 percentage of HCPs
|
28.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
b=Agree
|
12.3 percentage of HCPs
|
18.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
b=Strongly Agree
|
24.6 percentage of HCPs
|
16.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
b=Not Applicable
|
7.0 percentage of HCPs
|
6.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
b=Missing
|
5.3 percentage of HCPs
|
11.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
c=Strongly Disagree
|
0 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
c=Disagree
|
8.8 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
c=Neutral
|
29.8 percentage of HCPs
|
53.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
c=Agree
|
26.3 percentage of HCPs
|
18.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
c=Strongly Agree
|
26.3 percentage of HCPs
|
15.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
c=Not Applicable
|
3.5 percentage of HCPs
|
1.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
c=Missing
|
5.3 percentage of HCPs
|
11.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
d=Strongly Disagree
|
12.3 percentage of HCPs
|
20.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
d=Disagree
|
12.3 percentage of HCPs
|
3.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
d=Neutral
|
22.8 percentage of HCPs
|
30.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
d=Agree
|
15.8 percentage of HCPs
|
18.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
d=Strongly Agree
|
28.1 percentage of HCPs
|
15.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
d=Not Applicable
|
3.5 percentage of HCPs
|
1.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
d=Missing
|
5.3 percentage of HCPs
|
11.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
e=Strongly Disagree
|
1.8 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
e=Disagree
|
19.3 percentage of HCPs
|
11.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
e=Neutral
|
14.0 percentage of HCPs
|
26.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
e=Agree
|
29.8 percentage of HCPs
|
38.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
e=Strongly Agree
|
26.3 percentage of HCPs
|
10.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
e=Not Applicable
|
3.5 percentage of HCPs
|
1.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
e=Missing
|
5.3 percentage of HCPs
|
11.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
f=Neutral
|
33.3 percentage of HCPs
|
46.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
f=Agree
|
21.1 percentage of HCPs
|
20.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
f=Strongly Agree
|
26.3 percentage of HCPs
|
8.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
f=Not Applicable
|
3.5 percentage of HCPs
|
6.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
f=Missing
|
5.3 percentage of HCPs
|
11.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
g=Strongly Disagree
|
5.3 percentage of HCPs
|
11.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
g=Disagree
|
5.3 percentage of HCPs
|
1.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
g=Neutral
|
26.3 percentage of HCPs
|
36.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
g=Agree
|
26.3 percentage of HCPs
|
21.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
g=Strongly Agree
|
28.1 percentage of HCPs
|
15.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
g=Not Applicable
|
3.5 percentage of HCPs
|
1.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
g=Missing
|
5.3 percentage of HCPs
|
11.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
h=Strongly Disagree
|
0 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
h=Disagree
|
0 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
h=Neutral
|
10.5 percentage of HCPs
|
15.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
h=Agree
|
40.4 percentage of HCPs
|
38.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
h=Strongly Agree
|
28.1 percentage of HCPs
|
25.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
h=Not Applicable
|
15.8 percentage of HCPs
|
10.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
h=Missing
|
5.3 percentage of HCPs
|
11.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
a=Missing
|
5.3 percentage of HCPs
|
11.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
b=Strongly Disagree
|
7.0 percentage of HCPs
|
10.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
f=Strongly Disagree
|
0 percentage of HCPs
|
1.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area
f=Disagree
|
10.5 percentage of HCPs
|
5.0 percentage of HCPs
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 6 Day 1 (cycle length= 21 days)Population: Overall number analyzed included HCPs who completed Questions 3 and 4 of the survey at treatment Cycle 6.
HCPs who prepared study treatment within the pharmacy/drug preparation area responded at to the following HCPQ-Drug Preparation Area Questions 3 and 4, at Cycle 6 of the Treatment Crossover Period for every participant: "Looking back over the Atezolizumab treatment sessions, please indicate based on your opinion which administration method: Question 3. Was quickest from start to end of preparation to finish of administration (excluding observation period)?; Question 4. Required less resource use for preparation and administration, for example nursing time, facility costs, equipment etc?" The four available response options were: Atezolizumab IV, Atezolizumab SC, No Difference, and Missing. Percentages have been rounded off.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=57 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=60 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 and 4 of HCPQ - Drug Preparation Area
Question 3=Atezolizumab SC
|
71.9 percentage of HCPs
|
58.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 and 4 of HCPQ - Drug Preparation Area
Question 3=Atezolizumab IV
|
0 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 and 4 of HCPQ - Drug Preparation Area
Question 3=No Difference
|
17.5 percentage of HCPs
|
21.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 and 4 of HCPQ - Drug Preparation Area
Question 3=Missing
|
10.5 percentage of HCPs
|
20.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 and 4 of HCPQ - Drug Preparation Area
Question 4=Atezolizumab SC
|
64.9 percentage of HCPs
|
60.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 and 4 of HCPQ - Drug Preparation Area
Question 4=Atezolizumab IV
|
3.5 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 and 4 of HCPQ - Drug Preparation Area
Question 4=No Difference
|
21.1 percentage of HCPs
|
20.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 and 4 of HCPQ - Drug Preparation Area
Question 4=Missing
|
10.5 percentage of HCPs
|
20.0 percentage of HCPs
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 1 to 6 (cycle length=21 days)Population: Overall number analyzed included HCPs who completed Question 1 of the survey. For the questions related to IV access, the number analyzed only includes number of HCP responders for participants who required new IV access at a given treatment cycle. The number analyzed included HCPs who completed Question 1 of the survey at the specified treatment cycles. Percentages have been rounded off.
The HCPQ-Treatment Room Question 1 was completed for every participant at each treatment cycle of the Treatment Crossover Period (Cycles 1-6,i.e., 3 cycles of atezolizumab IV followed by 3 cycles of atezolizumab SC/vice versa) by HCPs who administered treatment to the study participants. HCPs responded to following parts of Question 1 that sought to evaluate the amount of time it took to complete activities related to treatment administration: "If new IV access was needed for this cycle of treatment, please indicate what type of IV access was provided (central venous catheter, peripherally inserted central catheter (PICC)/peripheral vein cannulation) \& how long (in minutes) this took to set up (only for participants receiving IV treatment)? How long (in minutes) did it take to administer the treatment, i.e. total infusion duration? How long (in minutes) was the participant in the treatment room for in total?" Durations with non-zero HCP responders have been reported here.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=87 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=86 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 1: Duration of Central Venous Catheter set up?
|
5 minutes
Interval 5.0 to 5.0
|
—
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 1: Duration of Peripherally Inserted Central Catheter set up?
|
30.0 minutes
Interval 8.0 to 30.0
|
—
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 1: Duration of Peripheral Vein Cannulation set up?
|
5.0 minutes
Interval 1.0 to 70.0
|
—
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 1: How Long did it Take to Administer the Treatment?
|
60.0 minutes
Interval 10.0 to 120.0
|
8.0 minutes
Interval 5.0 to 75.0
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 1: How Long was the Participant in the Treatment Room in Total?
|
92.0 minutes
Interval 35.0 to 390.0
|
55.0 minutes
Interval 10.0 to 260.0
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 2: Duration of Peripherally Inserted Central Catheter set up?
|
30.0 minutes
Interval 5.0 to 35.0
|
—
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 2: How Long did it Take to Administer the Treatment?
|
30.0 minutes
Interval 13.0 to 90.0
|
6.0 minutes
Interval 3.0 to 30.0
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 2: How Long was the Participant in the Treatment Room in Total?
|
75.0 minutes
Interval 33.0 to 330.0
|
41.0 minutes
Interval 10.0 to 238.0
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 3: Duration of Central Venous Catheter set up?
|
61.0 minutes
Interval 61.0 to 61.0
|
—
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 3: Duration of Peripherally Inserted Central Catheter set up?
|
17.5 minutes
Interval 5.0 to 30.0
|
—
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 3: Duration of Peripheral Vein Cannulation set up?
|
5.0 minutes
Interval 1.0 to 40.0
|
—
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 3: How Long did it Take to Administer the Treatment?
|
30.0 minutes
Interval 20.0 to 66.0
|
6.0 minutes
Interval 3.0 to 15.0
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 3: How Long was the Participant in the Treatment Room in Total?
|
70.0 minutes
Interval 35.0 to 323.0
|
49.0 minutes
Interval 5.0 to 128.0
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 4: Duration of Peripheral Vein Cannulation set up?
|
—
|
5.0 minutes
Interval 1.0 to 70.0
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 4: How Long did it Take to Administer the Treatment?
|
8.0 minutes
Interval 5.0 to 73.0
|
60.0 minutes
Interval 15.0 to 90.0
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 4: How Long was the Participant in the Treatment Room in Total?
|
45.0 minutes
Interval 10.0 to 320.0
|
97.0 minutes
Interval 20.0 to 360.0
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 5: Duration of Central Venous Catheter set up?
|
—
|
5.0 minutes
Interval 5.0 to 5.0
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 5: Duration of Peripherally Inserted Central Catheter set up?
|
—
|
22.5 minutes
Interval 7.0 to 51.0
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 5: Duration of Peripheral Vein Cannulation set up?
|
—
|
5.0 minutes
Interval 1.0 to 65.0
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 5: How Long did it Take to Administer the Treatment?
|
6.0 minutes
Interval 1.0 to 15.0
|
30.0 minutes
Interval 8.0 to 60.0
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 5: How Long was the Participant in the Treatment Room in Total?
|
35.0 minutes
Interval 8.0 to 200.0
|
71.0 minutes
Interval 30.0 to 360.0
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 4: Duration of Peripherally Inserted Central Catheter set up?
|
—
|
30.0 minutes
Interval 10.0 to 60.0
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 6: Duration of Peripherally Inserted Central Catheter set up?
|
—
|
12.5 minutes
Interval 5.0 to 30.0
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 6: Duration of Peripheral Vein Cannulation set up?
|
—
|
5.0 minutes
Interval 1.0 to 33.0
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 6: How Long did it Take to Administer the Treatment?
|
7.0 minutes
Interval 1.0 to 35.0
|
30.0 minutes
Interval 8.0 to 63.0
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 6: How Long was the Participant in the Treatment Room in Total?
|
37.5 minutes
Interval 9.0 to 240.0
|
61.0 minutes
Interval 14.0 to 380.0
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 2: Duration of Peripheral Vein Cannulation set up?
|
5.0 minutes
Interval 3.0 to 10.0
|
—
|
—
|
—
|
|
Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room
Cycle 4: Duration of Central Venous Catheter set up?
|
—
|
10.0 minutes
Interval 10.0 to 10.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 6 Day 1 (cycle length=21 days)Population: Overall number analyzed included HCPs who completed Question 2 of the survey at treatment Cycle 6. Percentages have been rounded off.
HCPs who administered treatment responded to Question 2: If all IV are switched to SC, please indicate how strongly you agree/disagree with each of following statements: a= Participants will be moved outside of infusion unit to receive SC injections (physician consultation room); b=Atezolizumab SC route will allow more flexible treatment scheduling; c=More participants will be treated in infusion unit; d=Waiting list for any IV treatment at infusion unit will be reduced; e=Staff resources will be re distributed to other departments of the hospital (less staffing required within infusion unit); f=There will still be sufficient interaction time between HCPs \& participants (for participant education); g=Staff will spend more time for further professional education/development; h=Staff will dedicate more time to attending to administrative tasks for participants; i=Participants will spend less time in care unit; j=Administration by atezolizumab SC injection is preferred by participants.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=58 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=61 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
a=Strongly Disagree
|
13.8 percentage of HCPs
|
11.5 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
a=Disagree
|
15.5 percentage of HCPs
|
23.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
a=Agree
|
27.6 percentage of HCPs
|
23.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
b=Disagree
|
19.0 percentage of HCPs
|
14.8 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
b=Neutral
|
10.3 percentage of HCPs
|
21.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
b=Agree
|
22.4 percentage of HCPs
|
21.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
b=Strongly Agree
|
27.6 percentage of HCPs
|
21.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
b=Missing
|
13.8 percentage of HCPs
|
19.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
c=Strongly Disagree
|
5.2 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
c=Disagree
|
15.5 percentage of HCPs
|
16.4 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
c=Neutral
|
12.1 percentage of HCPs
|
23.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
c=Agree
|
25.9 percentage of HCPs
|
26.2 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
c=Strongly Agree
|
27.6 percentage of HCPs
|
14.8 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
c=Not Applicable
|
0 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
c=Missing
|
13.8 percentage of HCPs
|
19.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
d=Strongly Disagree
|
6.9 percentage of HCPs
|
1.6 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
d=Disagree
|
5.2 percentage of HCPs
|
6.6 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
d=Neutral
|
25.9 percentage of HCPs
|
31.1 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
d=Agree
|
19.0 percentage of HCPs
|
23.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
d=Strongly Agree
|
27.6 percentage of HCPs
|
18.0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
d=Not Applicable
|
1.7 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
d=Missing
|
13.8 percentage of HCPs
|
19.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
e=Strongly Disagree
|
13.8 percentage of HCPs
|
11.5 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
e=Disagree
|
8.6 percentage of HCPs
|
14.8 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
e=Neutral
|
27.6 percentage of HCPs
|
26.2 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
e=Agree
|
10.3 percentage of HCPs
|
11.5 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
e=Not Applicable
|
6.9 percentage of HCPs
|
3.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
e=Missing
|
13.8 percentage of HCPs
|
19.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
f=Strongly Disagree
|
0 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
f=Disagree
|
17.2 percentage of HCPs
|
11.5 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
f=Neutral
|
17.2 percentage of HCPs
|
32.8 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
f=Agree
|
22.4 percentage of HCPs
|
16.4 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
f=Strongly Agree
|
29.3 percentage of HCPs
|
19.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
f=Not Applicable
|
0 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
g=Strongly Disagree
|
6.9 percentage of HCPs
|
1.6 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
g=Disagree
|
12.1 percentage of HCPs
|
11.5 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
g=Neutral
|
27.6 percentage of HCPs
|
27.9 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
g=Agree
|
13.8 percentage of HCPs
|
24.6 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
g=Not Applicable
|
0 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
g=Missing
|
13.8 percentage of HCPs
|
19.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
h=Strongly Disagree
|
6.9 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
h=Disagree
|
17.2 percentage of HCPs
|
24.6 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
h=Agree
|
24.1 percentage of HCPs
|
29.5 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
h=Strongly Agree
|
20.7 percentage of HCPs
|
13.1 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
h=Not Applicable
|
1.7 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
h=Missing
|
13.8 percentage of HCPs
|
19.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
i=Neutral
|
8.6 percentage of HCPs
|
14.8 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
i=Agree
|
37.9 percentage of HCPs
|
27.9 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
i=Strongly Agree
|
32.8 percentage of HCPs
|
31.1 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
i=Not Applicable
|
0 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
i=Missing
|
13.8 percentage of HCPs
|
19.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
j=Strongly Disagree
|
1.7 percentage of HCPs
|
1.6 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
j=Disagree
|
0 percentage of HCPs
|
3.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
j=Neutral
|
20.7 percentage of HCPs
|
21.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
j=Agree
|
31.0 percentage of HCPs
|
27.9 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
j=Strongly Agree
|
31.0 percentage of HCPs
|
26.2 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
j=Not Applicable
|
1.7 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
j=Missing
|
13.8 percentage of HCPs
|
19.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
a=Neutral
|
1.7 percentage of HCPs
|
6.6 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
a=Strongly Agree
|
17.2 percentage of HCPs
|
14.8 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
a=Not Applicable
|
10.3 percentage of HCPs
|
1.6 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
a=Missing
|
13.8 percentage of HCPs
|
19.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
b=Strongly Disagree
|
5.3 percentage of HCPs
|
1.6 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
b=Not Applicable
|
1.7 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
e=Strongly Agree
|
19.0 percentage of HCPs
|
13.1 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
f=Missing
|
13.8 percentage of HCPs
|
19.7 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
g=Strongly Agree
|
25.9 percentage of HCPs
|
14.8 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
h=Neutral
|
15.5 percentage of HCPs
|
13.1 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
i=Strongly Disagree
|
1.7 percentage of HCPs
|
1.6 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room
i=Disagree
|
5.2 percentage of HCPs
|
4.9 percentage of HCPs
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 6 Day 1 (cycle length=21 days)Population: Overall number analyzed included HCPs who completed Questions 3 to 7 of the survey at treatment Cycle 6.
HCPs who administered study treatment responded at Cycle 6 of the Treatment Crossover Period to the following HCPQ-treatment room Questions 3 to 7: "Looking back over the atezolizumab treatment sessions, please indicate based on your opinion which administration method: Question 3. Which method was most convenient for the participant? Question 4. Which method was best for optimizing participant care in your center? Question 5. Which method took the least time from start to finish of administration? Question 6. Which method required the least resource use for administration? Question 7. Which method was preferred by participants?" The five available response options were: Atezolizumab SC, Atezolizumab IV, No Difference, Unsure and Missing. Percentages have been rounded off.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=58 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=61 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q3=Atezolizumab SC
|
72.4 percentage of HCPs
|
63.9 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q3=Atezolizumab IV
|
5.2 percentage of HCPs
|
10.1 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q3=No Difference
|
6.9 percentage of HCPs
|
8.4 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q3=Unsure
|
1.7 percentage of HCPs
|
3.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q3= Missing
|
13.8 percentage of HCPs
|
14.4 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q4=Atezolizumab SC
|
55.2 percentage of HCPs
|
39.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q4=Atezolizumab IV
|
6.9 percentage of HCPs
|
1.5 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q4=No Difference
|
20.7 percentage of HCPs
|
31.1 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q4=Unsure
|
3.4 percentage of HCPs
|
1.6 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q4=Missing
|
13.8 percentage of HCPs
|
16.4 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q5=Atezolizumab SC
|
67.2 percentage of HCPs
|
52.5 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q5=No Difference
|
17.2 percentage of HCPs
|
27.9 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q5=Unsure
|
0 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q6=Atezolizumab IV
|
3.4 percentage of HCPs
|
1.6 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q6=No Difference
|
19.0 percentage of HCPs
|
31.1 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q7=Unsure
|
8.6 percentage of HCPs
|
14.8 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q7=Missing
|
13.8 percentage of HCPs
|
16.4 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q5=Missing
|
15.5 percentage of HCPs
|
16.4 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q6=Unsure
|
0 percentage of HCPs
|
0 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q6=Atezolizumab SC
|
63.8 percentage of HCPs
|
50.8 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q5=Atezolizumab IV
|
0 percentage of HCPs
|
3.3 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q6=Missing
|
13.8 percentage of HCPs
|
16.4 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q7=Atezolizumab SC
|
63.8 percentage of HCPs
|
52.5 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q7=Atezolizumab IV
|
10.3 percentage of HCPs
|
14.8 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room
Q7=No Difference
|
3.4 percentage of HCPs
|
1.6 percentage of HCPs
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 6 Day 1 (cycle length= 21 days)Population: Overall number analyzed included HCPs who completed Question 8 of the survey at treatment Cycle 6.
HCPs who administered study treatment responded at Cycle 6 of the treatment Cross-over Period to the following HCPQ-treatment room Question 8: How frequently would you offer or recommend atezolizumab SC administration to your participants in the future? The four available response options were Always, Sometimes, Never and Missing. Percentages have been rounded off.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=58 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=61 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 8 of HCPQ - Treatment Room
Question 8=Never
|
10.3 percentage of HCPs
|
14.8 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 8 of HCPQ - Treatment Room
Question 8=Missing
|
13.8 percentage of HCPs
|
16.4 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 8 of HCPQ - Treatment Room
Question 8=Always
|
41.4 percentage of HCPs
|
31.1 percentage of HCPs
|
—
|
—
|
|
Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 8 of HCPQ - Treatment Room
Question 8=Sometimes
|
34.5 percentage of HCPs
|
37.7 percentage of HCPs
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)Population: FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint.
EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), global health status (GHS) and quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=88 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=85 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
n=24 Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
n=82 Participants
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Physical Functioning Scale Score as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30)
Baseline
|
75.00 score on a scale
Standard Deviation 19.79
|
72.09 score on a scale
Standard Deviation 20.10
|
—
|
—
|
|
Change From Baseline Over Time in Physical Functioning Scale Score as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30)
Change at Cycle 3 Day 1
|
-0.46 score on a scale
Standard Deviation 19.62
|
-2.01 score on a scale
Standard Deviation 16.00
|
—
|
—
|
|
Change From Baseline Over Time in Physical Functioning Scale Score as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30)
Change at Cycle 6 Day 1
|
0.00 score on a scale
Standard Deviation 16.19
|
-1.60 score on a scale
Standard Deviation 16.74
|
—
|
—
|
|
Change From Baseline Over Time in Physical Functioning Scale Score as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30)
Change at Cycle 10 Day 1
|
—
|
—
|
0.91 score on a scale
Standard Deviation 19.55
|
2.06 score on a scale
Standard Deviation 16.64
|
|
Change From Baseline Over Time in Physical Functioning Scale Score as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30)
Change at Cycle 16 Day 1
|
—
|
—
|
0.48 score on a scale
Standard Deviation 16.22
|
1.03 score on a scale
Standard Deviation 15.77
|
|
Change From Baseline Over Time in Physical Functioning Scale Score as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30)
Change at End of Treatment
|
-13.75 score on a scale
Standard Deviation 28.39
|
-14.67 score on a scale
Standard Deviation 25.49
|
-8.06 score on a scale
Standard Deviation 21.26
|
-3.92 score on a scale
Standard Deviation 21.67
|
|
Change From Baseline Over Time in Physical Functioning Scale Score as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30)
Change at Cycle 7 Day 1
|
—
|
—
|
-2.22 score on a scale
Standard Deviation 13.85
|
0.03 score on a scale
Standard Deviation 15.39
|
|
Change From Baseline Over Time in Physical Functioning Scale Score as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30)
Change at Cycle 13 Day 1
|
—
|
—
|
-5.10 score on a scale
Standard Deviation 19.93
|
-0.43 score on a scale
Standard Deviation 17.98
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)Population: FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint.
EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=88 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=85 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
n=24 Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
n=82 Participants
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Role Functioning Scale Score as Assessed by EORTC-QLQ-C30
Baseline
|
77.46 score on a scale
Standard Deviation 25.15
|
73.73 score on a scale
Standard Deviation 27.86
|
—
|
—
|
|
Change From Baseline Over Time in Role Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 3 Day 1
|
1.16 score on a scale
Standard Deviation 29.25
|
-1.33 score on a scale
Standard Deviation 21.88
|
—
|
—
|
|
Change From Baseline Over Time in Role Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 6 Day 1
|
-2.01 score on a scale
Standard Deviation 26.13
|
-1.64 score on a scale
Standard Deviation 24.10
|
—
|
—
|
|
Change From Baseline Over Time in Role Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 7 Day 1
|
—
|
—
|
-8.33 score on a scale
Standard Deviation 18.39
|
-5.41 score on a scale
Standard Deviation 26.00
|
|
Change From Baseline Over Time in Role Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 10 Day 1
|
—
|
—
|
-6.82 score on a scale
Standard Deviation 23.94
|
-2.03 score on a scale
Standard Deviation 24.20
|
|
Change From Baseline Over Time in Role Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 13 Day 1
|
—
|
—
|
-6.86 score on a scale
Standard Deviation 21.29
|
-1.60 score on a scale
Standard Deviation 26.52
|
|
Change From Baseline Over Time in Role Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 16 Day 1
|
—
|
—
|
-2.38 score on a scale
Standard Deviation 14.41
|
-2.74 score on a scale
Standard Deviation 26.84
|
|
Change From Baseline Over Time in Role Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at End of Treatment
|
-16.67 score on a scale
Standard Deviation 43.81
|
-15.00 score on a scale
Standard Deviation 24.15
|
-9.72 score on a scale
Standard Deviation 24.04
|
-8.01 score on a scale
Standard Deviation 25.88
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)Population: FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint.
EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=88 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=85 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
n=24 Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
n=82 Participants
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Emotional Functioning Scale Score as Assessed by EORTC-QLQ-C30
Baseline
|
79.48 score on a scale
Standard Deviation 22.43
|
75.98 score on a scale
Standard Deviation 23.44
|
—
|
—
|
|
Change From Baseline Over Time in Emotional Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 3 Day 1
|
2.62 score on a scale
Standard Deviation 20.52
|
0.89 score on a scale
Standard Deviation 16.47
|
—
|
—
|
|
Change From Baseline Over Time in Emotional Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 6 Day 1
|
0.77 score on a scale
Standard Deviation 17.68
|
4.10 score on a scale
Standard Deviation 23.30
|
—
|
—
|
|
Change From Baseline Over Time in Emotional Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 7 Day 1
|
—
|
—
|
-3.47 score on a scale
Standard Deviation 22.64
|
2.56 score on a scale
Standard Deviation 15.84
|
|
Change From Baseline Over Time in Emotional Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 13 Day 1
|
—
|
—
|
0.98 score on a scale
Standard Deviation 22.61
|
3.46 score on a scale
Standard Deviation 19.00
|
|
Change From Baseline Over Time in Emotional Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 16 Day 1
|
—
|
—
|
-2.98 score on a scale
Standard Deviation 23.02
|
0.37 score on a scale
Standard Deviation 17.49
|
|
Change From Baseline Over Time in Emotional Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at End of Treatment
|
-6.71 score on a scale
Standard Deviation 16.98
|
-6.67 score on a scale
Standard Deviation 21.08
|
-8.33 score on a scale
Standard Deviation 28.45
|
-5.05 score on a scale
Standard Deviation 18.16
|
|
Change From Baseline Over Time in Emotional Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 10 Day 1
|
—
|
—
|
-3.03 score on a scale
Standard Deviation 26.92
|
4.37 score on a scale
Standard Deviation 16.91
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)Population: FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint.
EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=88 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=85 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
n=24 Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
n=82 Participants
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Cognitive Functioning Scale Score as Assessed by EORTC-QLQ-C30
Baseline
|
87.31 score on a scale
Standard Deviation 21.74
|
85.69 score on a scale
Standard Deviation 19.78
|
—
|
—
|
|
Change From Baseline Over Time in Cognitive Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 3 Day 1
|
2.31 score on a scale
Standard Deviation 17.31
|
-5.56 score on a scale
Standard Deviation 19.05
|
—
|
—
|
|
Change From Baseline Over Time in Cognitive Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 6 Day 1
|
-5.75 score on a scale
Standard Deviation 18.87
|
-1.09 score on a scale
Standard Deviation 20.15
|
—
|
—
|
|
Change From Baseline Over Time in Cognitive Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 7 Day 1
|
—
|
—
|
-4.17 score on a scale
Standard Deviation 13.23
|
-2.16 score on a scale
Standard Deviation 19.37
|
|
Change From Baseline Over Time in Cognitive Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 10 Day 1
|
—
|
—
|
-5.30 score on a scale
Standard Deviation 11.94
|
-0.41 score on a scale
Standard Deviation 17.76
|
|
Change From Baseline Over Time in Cognitive Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 13 Day 1
|
—
|
—
|
-11.76 score on a scale
Standard Deviation 21.86
|
-1.14 score on a scale
Standard Deviation 21.21
|
|
Change From Baseline Over Time in Cognitive Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 16 Day 1
|
—
|
—
|
-7.14 score on a scale
Standard Deviation 12.60
|
-2.99 score on a scale
Standard Deviation 21.11
|
|
Change From Baseline Over Time in Cognitive Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at End of Treatment
|
-6.94 score on a scale
Standard Deviation 25.08
|
3.33 score on a scale
Standard Deviation 17.21
|
-5.56 score on a scale
Standard Deviation 23.40
|
-7.36 score on a scale
Standard Deviation 22.70
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)Population: FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint.
EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=88 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=85 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
n=24 Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
n=82 Participants
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Social Functioning Scale Score as Assessed by EORTC-QLQ-C30
Baseline
|
82.95 score on a scale
Standard Deviation 23.02
|
82.35 score on a scale
Standard Deviation 22.76
|
—
|
—
|
|
Change From Baseline Over Time in Social Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 3 Day 1
|
3.70 score on a scale
Standard Deviation 23.61
|
-3.56 score on a scale
Standard Deviation 21.10
|
—
|
—
|
|
Change From Baseline Over Time in Social Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 6 Day 1
|
-2.87 score on a scale
Standard Deviation 24.81
|
-1.91 score on a scale
Standard Deviation 22.38
|
—
|
—
|
|
Change From Baseline Over Time in Social Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 7 Day 1
|
—
|
—
|
-6.25 score on a scale
Standard Deviation 27.72
|
0.22 score on a scale
Standard Deviation 21.71
|
|
Change From Baseline Over Time in Social Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 10 Day 1
|
—
|
—
|
-3.79 score on a scale
Standard Deviation 27.18
|
-0.20 score on a scale
Standard Deviation 25.32
|
|
Change From Baseline Over Time in Social Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at End of Treatment
|
-12.50 score on a scale
Standard Deviation 46.13
|
-15.00 score on a scale
Standard Deviation 29.87
|
-15.28 score on a scale
Standard Deviation 24.53
|
-4.98 score on a scale
Standard Deviation 27.84
|
|
Change From Baseline Over Time in Social Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 13 Day 1
|
—
|
—
|
-3.92 score on a scale
Standard Deviation 17.21
|
-0.46 score on a scale
Standard Deviation 23.57
|
|
Change From Baseline Over Time in Social Functioning Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 16 Day 1
|
—
|
—
|
-5.95 score on a scale
Standard Deviation 24.11
|
0.50 score on a scale
Standard Deviation 19.67
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)Population: FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint.
EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The symptom items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=88 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=85 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
n=24 Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
n=82 Participants
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Fatigue Scale Score as Assessed by EORTC-QLQ-C30
Baseline
|
30.81 score on a scale
Standard Deviation 25.81
|
36.08 score on a scale
Standard Deviation 26.33
|
—
|
—
|
|
Change From Baseline Over Time in Fatigue Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 13 Day 1
|
—
|
—
|
4.58 score on a scale
Standard Deviation 15.24
|
3.96 score on a scale
Standard Deviation 26.02
|
|
Change From Baseline Over Time in Fatigue Scale Score as Assessed by EORTC-QLQ-C30
Change at End of Treatment
|
6.48 score on a scale
Standard Deviation 24.37
|
4.44 score on a scale
Standard Deviation 24.68
|
1.39 score on a scale
Standard Deviation 27.86
|
7.65 score on a scale
Standard Deviation 24.13
|
|
Change From Baseline Over Time in Fatigue Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 7 Day 1
|
—
|
—
|
2.78 score on a scale
Standard Deviation 18.02
|
1.59 score on a scale
Standard Deviation 23.27
|
|
Change From Baseline Over Time in Fatigue Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 3 Day 1
|
0.15 score on a scale
Standard Deviation 26.67
|
-1.63 score on a scale
Standard Deviation 20.32
|
—
|
—
|
|
Change From Baseline Over Time in Fatigue Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 6 Day 1
|
4.41 score on a scale
Standard Deviation 25.06
|
1.46 score on a scale
Standard Deviation 21.13
|
—
|
—
|
|
Change From Baseline Over Time in Fatigue Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 10 Day 1
|
—
|
—
|
3.03 score on a scale
Standard Deviation 21.74
|
-0.14 score on a scale
Standard Deviation 21.63
|
|
Change From Baseline Over Time in Fatigue Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 16 Day 1
|
—
|
—
|
5.56 score on a scale
Standard Deviation 20.32
|
1.00 score on a scale
Standard Deviation 26.64
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)Population: FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint.
EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The symptom items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=88 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=85 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
n=24 Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
n=82 Participants
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Nausea and Vomiting Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 3 Day 1
|
2.31 score on a scale
Standard Deviation 15.65
|
1.56 score on a scale
Standard Deviation 18.21
|
—
|
—
|
|
Change From Baseline Over Time in Nausea and Vomiting Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 6 Day 1
|
2.01 score on a scale
Standard Deviation 12.90
|
3.01 score on a scale
Standard Deviation 14.11
|
—
|
—
|
|
Change From Baseline Over Time in Nausea and Vomiting Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 13 Day 1
|
—
|
—
|
0.98 score on a scale
Standard Deviation 4.04
|
0.46 score on a scale
Standard Deviation 14.16
|
|
Change From Baseline Over Time in Nausea and Vomiting Scale Score as Assessed by EORTC-QLQ-C30
Change at End of Treatment
|
-3.03 score on a scale
Standard Deviation 16.36
|
6.67 score on a scale
Standard Deviation 23.83
|
6.94 score on a scale
Standard Deviation 18.33
|
1.73 score on a scale
Standard Deviation 12.56
|
|
Change From Baseline Over Time in Nausea and Vomiting Scale Score as Assessed by EORTC-QLQ-C30
Baseline
|
5.30 score on a scale
Standard Deviation 13.50
|
5.88 score on a scale
Standard Deviation 14.48
|
—
|
—
|
|
Change From Baseline Over Time in Nausea and Vomiting Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 7 Day 1
|
—
|
—
|
4.86 score on a scale
Standard Deviation 9.17
|
-0.65 score on a scale
Standard Deviation 9.15
|
|
Change From Baseline Over Time in Nausea and Vomiting Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 10 Day 1
|
—
|
—
|
3.79 score on a scale
Standard Deviation 10.20
|
1.02 score on a scale
Standard Deviation 9.57
|
|
Change From Baseline Over Time in Nausea and Vomiting Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 16 Day 1
|
—
|
—
|
1.19 score on a scale
Standard Deviation 4.45
|
0.75 score on a scale
Standard Deviation 13.11
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)Population: FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint.
EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The symptom items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=88 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=85 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
n=24 Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
n=82 Participants
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Pain Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 3 Day 1
|
0.93 score on a scale
Standard Deviation 22.88
|
-3.56 score on a scale
Standard Deviation 26.47
|
—
|
—
|
|
Change From Baseline Over Time in Pain Scale Score as Assessed by EORTC-QLQ-C30
Baseline
|
22.16 score on a scale
Standard Deviation 25.23
|
29.22 score on a scale
Standard Deviation 30.74
|
—
|
—
|
|
Change From Baseline Over Time in Pain Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 6 Day 1
|
4.02 score on a scale
Standard Deviation 23.22
|
-1.09 score on a scale
Standard Deviation 25.43
|
—
|
—
|
|
Change From Baseline Over Time in Pain Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 7 Day 1
|
—
|
—
|
4.17 score on a scale
Standard Deviation 28.34
|
1.52 score on a scale
Standard Deviation 28.89
|
|
Change From Baseline Over Time in Pain Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 13 Day 1
|
—
|
—
|
7.84 score on a scale
Standard Deviation 35.90
|
1.14 score on a scale
Standard Deviation 25.81
|
|
Change From Baseline Over Time in Pain Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 16 Day 1
|
—
|
—
|
4.76 score on a scale
Standard Deviation 32.31
|
1.24 score on a scale
Standard Deviation 28.32
|
|
Change From Baseline Over Time in Pain Scale Score as Assessed by EORTC-QLQ-C30
Change at End of Treatment
|
12.50 score on a scale
Standard Deviation 43.30
|
-10.00 score on a scale
Standard Deviation 28.54
|
18.06 score on a scale
Standard Deviation 33.66
|
6.28 score on a scale
Standard Deviation 30.35
|
|
Change From Baseline Over Time in Pain Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 10 Day 1
|
—
|
—
|
3.79 score on a scale
Standard Deviation 32.50
|
-1.22 score on a scale
Standard Deviation 26.42
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)Population: FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint.
EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The dyspnoea scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=88 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=85 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
n=24 Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
n=82 Participants
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Dyspnoea Scale Score as Assessed by EORTC-QLQ-C30
Baseline
|
25.38 score on a scale
Standard Deviation 26.26
|
30.59 score on a scale
Standard Deviation 30.52
|
—
|
—
|
|
Change From Baseline Over Time in Dyspnoea Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 3 Day 1
|
5.09 score on a scale
Standard Deviation 26.63
|
0.89 score on a scale
Standard Deviation 26.83
|
—
|
—
|
|
Change From Baseline Over Time in Dyspnoea Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 6 Day 1
|
-0.57 score on a scale
Standard Deviation 22.07
|
-2.73 score on a scale
Standard Deviation 31.80
|
—
|
—
|
|
Change From Baseline Over Time in Dyspnoea Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 7 Day 1
|
—
|
—
|
4.17 score on a scale
Standard Deviation 31.57
|
-3.03 score on a scale
Standard Deviation 27.14
|
|
Change From Baseline Over Time in Dyspnoea Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 10 Day 1
|
—
|
—
|
3.03 score on a scale
Standard Deviation 25.01
|
-5.28 score on a scale
Standard Deviation 25.37
|
|
Change From Baseline Over Time in Dyspnoea Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 13 Day 1
|
—
|
—
|
0.00 score on a scale
Standard Deviation 28.87
|
0.00 score on a scale
Standard Deviation 24.22
|
|
Change From Baseline Over Time in Dyspnoea Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 16 Day 1
|
—
|
—
|
0.00 score on a scale
Standard Deviation 29.24
|
-4.48 score on a scale
Standard Deviation 26.52
|
|
Change From Baseline Over Time in Dyspnoea Scale Score as Assessed by EORTC-QLQ-C30
Change at End of Treatment
|
8.33 score on a scale
Standard Deviation 15.08
|
16.67 score on a scale
Standard Deviation 28.33
|
4.17 score on a scale
Standard Deviation 31.57
|
2.60 score on a scale
Standard Deviation 26.36
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)Population: FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint.
EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The insomnia scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=88 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=85 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
n=24 Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
n=82 Participants
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Insomnia Scale Score as Assessed by EORTC-QLQ-C30
Baseline
|
23.11 score on a scale
Standard Deviation 27.85
|
28.63 score on a scale
Standard Deviation 31.77
|
—
|
—
|
|
Change From Baseline Over Time in Insomnia Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 3 Day 1
|
0.46 score on a scale
Standard Deviation 26.53
|
-0.44 score on a scale
Standard Deviation 20.13
|
—
|
—
|
|
Change From Baseline Over Time in Insomnia Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 6 Day 1
|
0.57 score on a scale
Standard Deviation 23.77
|
2.19 score on a scale
Standard Deviation 27.13
|
—
|
—
|
|
Change From Baseline Over Time in Insomnia Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 7 Day 1
|
—
|
—
|
15.28 score on a scale
Standard Deviation 32.57
|
2.16 score on a scale
Standard Deviation 23.78
|
|
Change From Baseline Over Time in Insomnia Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 10 Day 1
|
—
|
—
|
6.06 score on a scale
Standard Deviation 24.42
|
2.44 score on a scale
Standard Deviation 25.00
|
|
Change From Baseline Over Time in Insomnia Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 13 Day 1
|
—
|
—
|
15.69 score on a scale
Standard Deviation 20.81
|
1.37 score on a scale
Standard Deviation 25.72
|
|
Change From Baseline Over Time in Insomnia Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 16 Day 1
|
—
|
—
|
0.00 score on a scale
Standard Deviation 13.07
|
3.98 score on a scale
Standard Deviation 22.11
|
|
Change From Baseline Over Time in Insomnia Scale Score as Assessed by EORTC-QLQ-C30
Change at End of Treatment
|
-2.78 score on a scale
Standard Deviation 17.16
|
-13.33 score on a scale
Standard Deviation 35.83
|
4.17 score on a scale
Standard Deviation 38.46
|
3.90 score on a scale
Standard Deviation 25.35
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)Population: FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint.
EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The appetite loss scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=88 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=85 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
n=24 Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
n=82 Participants
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Appetite Loss Scale Score as Assessed by EORTC-QLQ-C30
Baseline
|
16.67 score on a scale
Standard Deviation 28.14
|
21.96 score on a scale
Standard Deviation 28.43
|
—
|
—
|
|
Change From Baseline Over Time in Appetite Loss Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 3 Day 1
|
2.31 score on a scale
Standard Deviation 32.30
|
2.22 score on a scale
Standard Deviation 23.46
|
—
|
—
|
|
Change From Baseline Over Time in Appetite Loss Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 6 Day 1
|
2.87 score on a scale
Standard Deviation 30.13
|
-2.19 score on a scale
Standard Deviation 26.44
|
—
|
—
|
|
Change From Baseline Over Time in Appetite Loss Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 7 Day 1
|
—
|
—
|
4.17 score on a scale
Standard Deviation 30.00
|
-3.03 score on a scale
Standard Deviation 27.14
|
|
Change From Baseline Over Time in Appetite Loss Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 10 Day 1
|
—
|
—
|
6.06 score on a scale
Standard Deviation 35.09
|
-2.03 score on a scale
Standard Deviation 25.31
|
|
Change From Baseline Over Time in Appetite Loss Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 13 Day 1
|
—
|
—
|
-1.96 score on a scale
Standard Deviation 18.52
|
-0.46 score on a scale
Standard Deviation 26.35
|
|
Change From Baseline Over Time in Appetite Loss Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 16 Day 1
|
—
|
—
|
0.00 score on a scale
Standard Deviation 13.07
|
0.00 score on a scale
Standard Deviation 25.29
|
|
Change From Baseline Over Time in Appetite Loss Scale Score as Assessed by EORTC-QLQ-C30
Change at End of Treatment
|
-6.06 score on a scale
Standard Deviation 25.03
|
3.33 score on a scale
Standard Deviation 36.68
|
0.00 score on a scale
Standard Deviation 31.08
|
2.63 score on a scale
Standard Deviation 25.97
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)Population: FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint.
EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The constipation scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=88 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=85 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
n=24 Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
n=82 Participants
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Constipation Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 3 Day 1
|
0.00 score on a scale
Standard Deviation 29.07
|
-2.67 score on a scale
Standard Deviation 32.77
|
—
|
—
|
|
Change From Baseline Over Time in Constipation Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 6 Day 1
|
-4.60 score on a scale
Standard Deviation 28.92
|
-3.28 score on a scale
Standard Deviation 30.25
|
—
|
—
|
|
Change From Baseline Over Time in Constipation Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 7 Day 1
|
—
|
—
|
-4.17 score on a scale
Standard Deviation 20.41
|
-9.52 score on a scale
Standard Deviation 34.98
|
|
Change From Baseline Over Time in Constipation Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 10 Day 1
|
—
|
—
|
-3.03 score on a scale
Standard Deviation 25.01
|
-6.10 score on a scale
Standard Deviation 30.60
|
|
Change From Baseline Over Time in Constipation Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 13 Day 1
|
—
|
—
|
-1.96 score on a scale
Standard Deviation 21.96
|
-4.11 score on a scale
Standard Deviation 29.37
|
|
Change From Baseline Over Time in Constipation Scale Score as Assessed by EORTC-QLQ-C30
Change at End of Treatment
|
-12.12 score on a scale
Standard Deviation 45.39
|
16.67 score on a scale
Standard Deviation 39.28
|
1.39 score on a scale
Standard Deviation 23.01
|
-3.46 score on a scale
Standard Deviation 35.29
|
|
Change From Baseline Over Time in Constipation Scale Score as Assessed by EORTC-QLQ-C30
Baseline
|
19.32 score on a scale
Standard Deviation 30.63
|
21.96 score on a scale
Standard Deviation 33.55
|
—
|
—
|
|
Change From Baseline Over Time in Constipation Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 16 Day 1
|
—
|
—
|
-4.76 score on a scale
Standard Deviation 17.82
|
-1.00 score on a scale
Standard Deviation 32.29
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)Population: FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint.
EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The diarrhoea scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=88 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=85 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
n=24 Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
n=82 Participants
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Diarrhoea Scale Score as Assessed by EORTC-QLQ-C30
Baseline
|
5.68 score on a scale
Standard Deviation 15.35
|
7.06 score on a scale
Standard Deviation 15.51
|
—
|
—
|
|
Change From Baseline Over Time in Diarrhoea Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 6 Day 1
|
-2.30 score on a scale
Standard Deviation 17.51
|
3.28 score on a scale
Standard Deviation 21.69
|
—
|
—
|
|
Change From Baseline Over Time in Diarrhoea Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 7 Day 1
|
—
|
—
|
2.78 score on a scale
Standard Deviation 16.79
|
-1.30 score on a scale
Standard Deviation 19.82
|
|
Change From Baseline Over Time in Diarrhoea Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 10 Day 1
|
—
|
—
|
4.55 score on a scale
Standard Deviation 18.67
|
2.03 score on a scale
Standard Deviation 19.14
|
|
Change From Baseline Over Time in Diarrhoea Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 13 Day 1
|
—
|
—
|
9.80 score on a scale
Standard Deviation 34.89
|
-1.83 score on a scale
Standard Deviation 16.56
|
|
Change From Baseline Over Time in Diarrhoea Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 16 Day 1
|
—
|
—
|
9.52 score on a scale
Standard Deviation 30.46
|
0.50 score on a scale
Standard Deviation 22.09
|
|
Change From Baseline Over Time in Diarrhoea Scale Score as Assessed by EORTC-QLQ-C30
Change at End of Treatment
|
-5.56 score on a scale
Standard Deviation 19.25
|
-13.33 score on a scale
Standard Deviation 23.31
|
5.56 score on a scale
Standard Deviation 27.22
|
-0.43 score on a scale
Standard Deviation 20.59
|
|
Change From Baseline Over Time in Diarrhoea Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 3 Day 1
|
0.93 score on a scale
Standard Deviation 18.53
|
2.22 score on a scale
Standard Deviation 18.45
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)Population: FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint.
EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The financial difficulties scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=87 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=85 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
n=24 Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
n=81 Participants
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Financial Difficulties Scale Score as Assessed by EORTC-QLQ-C30
Baseline
|
13.79 score on a scale
Standard Deviation 25.19
|
20.39 score on a scale
Standard Deviation 31.33
|
—
|
—
|
|
Change From Baseline Over Time in Financial Difficulties Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 3 Day 1
|
7.98 score on a scale
Standard Deviation 27.87
|
-1.33 score on a scale
Standard Deviation 23.53
|
—
|
—
|
|
Change From Baseline Over Time in Financial Difficulties Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 6 Day 1
|
11.11 score on a scale
Standard Deviation 32.33
|
0.00 score on a scale
Standard Deviation 25.09
|
—
|
—
|
|
Change From Baseline Over Time in Financial Difficulties Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 7 Day 1
|
—
|
—
|
0.00 score on a scale
Standard Deviation 17.03
|
-0.44 score on a scale
Standard Deviation 28.54
|
|
Change From Baseline Over Time in Financial Difficulties Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 10 Day 1
|
—
|
—
|
0.00 score on a scale
Standard Deviation 14.55
|
1.65 score on a scale
Standard Deviation 27.34
|
|
Change From Baseline Over Time in Financial Difficulties Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 13 Day 1
|
—
|
—
|
-1.96 score on a scale
Standard Deviation 14.29
|
2.35 score on a scale
Standard Deviation 28.35
|
|
Change From Baseline Over Time in Financial Difficulties Scale Score as Assessed by EORTC-QLQ-C30
Change at End of Treatment
|
24.24 score on a scale
Standard Deviation 44.95
|
0.00 score on a scale
Standard Deviation 35.14
|
-1.39 score on a scale
Standard Deviation 20.80
|
5.70 score on a scale
Standard Deviation 29.51
|
|
Change From Baseline Over Time in Financial Difficulties Scale Score as Assessed by EORTC-QLQ-C30
Change at Cycle 16 Day 1
|
—
|
—
|
-2.38 score on a scale
Standard Deviation 8.91
|
5.47 score on a scale
Standard Deviation 26.33
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)Population: FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint.
EORTC QLQ-C30 consists of 30 questions that assess participant functioning (physical, emotional, role, cognitive, and social), symptom scales (fatigue, nausea and vomiting, pain), global health/ QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Change in HRQoL was assessed using participant responses to questions regarding Global Health Status (Q29: GHS; "How would you rate your overall health during the past week?") and QoL (Q30: QoL; "How would you rate your overall quality of life during the past week?") and were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized. Scores range from 0-100. A higher score indicates a better outcome.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=87 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=85 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
n=24 Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
n=82 Participants
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30
Change at Cycle 16 Day 1
|
—
|
—
|
-7.74 score on a scale
Standard Deviation 18.33
|
3.23 score on a scale
Standard Deviation 21.07
|
|
Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30
Change at End of Treatment
|
-28.79 score on a scale
Standard Deviation 26.71
|
-11.67 score on a scale
Standard Deviation 19.72
|
-13.54 score on a scale
Standard Deviation 25.40
|
-4.76 score on a scale
Standard Deviation 22.56
|
|
Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30
Change at Cycle 3 Day 1
|
0.12 score on a scale
Standard Deviation 22.95
|
-0.22 score on a scale
Standard Deviation 18.43
|
—
|
—
|
|
Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30
Change at Cycle 6 Day 1
|
-2.49 score on a scale
Standard Deviation 18.83
|
-0.27 score on a scale
Standard Deviation 22.26
|
—
|
—
|
|
Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30
Change at Cycle 13 Day 1
|
—
|
—
|
-5.39 score on a scale
Standard Deviation 15.29
|
0.23 score on a scale
Standard Deviation 19.24
|
|
Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30
Change at Cycle 7 Day 1
|
—
|
—
|
-2.08 score on a scale
Standard Deviation 19.85
|
1.84 score on a scale
Standard Deviation 19.94
|
|
Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30
Change at Cycle 10 Day 1
|
—
|
—
|
-3.79 score on a scale
Standard Deviation 16.21
|
1.73 score on a scale
Standard Deviation 17.65
|
|
Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30
Baseline
|
67.05 score on a scale
Standard Deviation 19.97
|
64.80 score on a scale
Standard Deviation 21.45
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Cycle 16 (cycle length= 21 days)Population: FAS included all randomized participants. Ongoing clinical benefit at Cycle 16 was summarized for overall participants, as due to switches in mode of administration up to Cycle 16, it would be impossible to isolate the effect of the randomization arms. Hence, per-arm data can't be presented.
Participants were assessed for clinical benefit at every tumour assessment visit, which was conducted as per the local standard of care. Percentages have been rounded off.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=179 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Percentage of Participants With Ongoing Clinical Benefit
|
44.7 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 90 days after the final dose of study drug (Up to 2.4 years)Population: Safety evaluable population included all participants who received at least one dose of study treatment.
An AE is untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to the investigational product. Percentages have been rounded off.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=160 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=155 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
n=26 Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
n=89 Participants
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
59.4 percentage of participants
|
47.7 percentage of participants
|
76.9 percentage of participants
|
67.4 percentage of participants
|
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 up to Cycle 3 Day 21; From Cycle 4 Day 1 up to Cycle 6 Day 21 (cycle length=21 days)Population: Safety evaluable population included all participants who received at least one dose of study treatment. In this analysis, participants were grouped by study arm and treatment period during the Crossover Period.
An AE is untoward medical occurrence in participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. The safety of switching from atezolizumab SC to atezolizumab IV and from atezolizumab IV to atezolizumab SC is being assessed in this outcome measure. Percentages have been rounded off.
Outcome measures
| Measure |
Crossover Atezolizumab IV/SC
n=89 Participants
Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
Crossover Atezolizumab SC/IV
n=69 Participants
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period.
|
All Participants
n=86 Participants
Participants either received atezolizumab IV, 1200 mg for the first 3 cycles, followed by SC, 1875 mg for the next three cycles, or atezolizumab SC 1875 mg, for the first 3 cycles, followed by IV 1200 mg for the next three cycles during the Treatment Crossover Period.
|
Continuation Atezolizumab SC
n=71 Participants
After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|
|
Percentage of Participants With AEs During Treatment Cross-over Period
|
62.9 percentage of participants
|
39.1 percentage of participants
|
54.7 percentage of participants
|
53.5 percentage of participants
|
Adverse Events
Crossover Atezolizumab IV
Serious events: 15 serious events
Other events: 60 other events
Deaths: 16 deaths
Crossover Atezolizumab SC
Serious events: 13 serious events
Other events: 52 other events
Deaths: 21 deaths
Continuation Atezolizumab IV
Serious events: 6 serious events
Other events: 16 other events
Deaths: 5 deaths
Continuation Atezolizumab SC
Serious events: 12 serious events
Other events: 44 other events
Deaths: 12 deaths
All Participants
Serious events: 45 serious events
Other events: 172 other events
Deaths: 54 deaths
Serious adverse events
| Measure |
Crossover Atezolizumab IV
n=160 participants at risk
Participants who were administered atezolizumab, IV infusion, 1200 mg, Q3W in Cycles 1 to 3 or Cycles 4 to 6 (cycle length=21 days), depending on the sequence (IV/SC or SC/IV) they were assigned in the Treatment Crossover Period are reported in this arm.
|
Crossover Atezolizumab SC
n=155 participants at risk
Participants who were administered atezolizumab, SC injections, 1875 mg, Q3W for Cycles 1 to 3 or Cycles 4 to 6 (cycle length=21 days), depending on the sequence (IV/SC or SC/IV) they were assigned in the Treatment Crossover Period are reported in this arm.
|
Continuation Atezolizumab IV
n=26 participants at risk
Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
Continuation Atezolizumab SC
n=89 participants at risk
Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
All Participants
n=175 participants at risk
This arm includes all participants who were administered atezolizumab IV, 1200 mg, and/or SC, 1875 mg Q3W up to Cycle 16 in the Treatment Crossover Period and Treatment Continuation Period for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Cardiac disorders
Angina pectoris
|
0.62%
1/160 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Cardiac disorders
Atrial fibrillation
|
0.62%
1/160 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
2/175 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Cardiac disorders
Autoimmune myocarditis
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Cardiac disorders
Cardiac tamponade
|
0.62%
1/160 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.62%
1/160 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.62%
1/160 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
2/175 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
General disorders
Pain
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
General disorders
Pyrexia
|
0.62%
1/160 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Infections and infestations
Bronchitis
|
0.62%
1/160 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Infections and infestations
COVID-19
|
0.62%
1/160 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
3.8%
1/26 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
1/89 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.7%
3/175 • Number of events 3 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Infections and infestations
Pneumonia bacterial
|
1.2%
2/160 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
1/89 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
2.3%
4/175 • Number of events 4 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Infections and infestations
Sepsis
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Infections and infestations
Skin infection
|
0.62%
1/160 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.2%
2/160 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
2/175 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
1/89 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
2/175 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Nervous system disorders
Immune-mediated encephalitis
|
1.2%
2/160 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
2/175 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
3.8%
1/26 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
2/175 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.62%
1/160 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
1/89 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
2/175 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.3%
2/155 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
2/175 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
2.2%
2/89 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.7%
3/175 • Number of events 4 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Vascular disorders
Hypertension
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Vascular disorders
Peripheral ischaemia
|
0.62%
1/160 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Vascular disorders
Shock
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
1/89 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
1/89 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
General disorders
Chest pain
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
1/89 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
General disorders
Death
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
3.8%
1/26 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
3.8%
1/26 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
3.8%
1/26 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
3.4%
3/89 • Number of events 3 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
2.3%
4/175 • Number of events 4 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
1/89 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
1/89 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
1/89 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
3.8%
1/26 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
1/89 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
1/89 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
1/89 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Nervous system disorders
Seizure
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
3.8%
1/26 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
1/89 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
3.8%
1/26 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
1/89 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.57%
1/175 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
Other adverse events
| Measure |
Crossover Atezolizumab IV
n=160 participants at risk
Participants who were administered atezolizumab, IV infusion, 1200 mg, Q3W in Cycles 1 to 3 or Cycles 4 to 6 (cycle length=21 days), depending on the sequence (IV/SC or SC/IV) they were assigned in the Treatment Crossover Period are reported in this arm.
|
Crossover Atezolizumab SC
n=155 participants at risk
Participants who were administered atezolizumab, SC injections, 1875 mg, Q3W for Cycles 1 to 3 or Cycles 4 to 6 (cycle length=21 days), depending on the sequence (IV/SC or SC/IV) they were assigned in the Treatment Crossover Period are reported in this arm.
|
Continuation Atezolizumab IV
n=26 participants at risk
Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
Continuation Atezolizumab SC
n=89 participants at risk
Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
All Participants
n=175 participants at risk
This arm includes all participants who were administered atezolizumab IV, 1200 mg, and/or SC, 1875 mg Q3W up to Cycle 16 in the Treatment Crossover Period and Treatment Continuation Period for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
9/160 • Number of events 11 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
6.5%
10/155 • Number of events 10 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
15.4%
4/26 • Number of events 5 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
7.9%
7/89 • Number of events 10 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
13.7%
24/175 • Number of events 36 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
General disorders
Asthenia
|
5.6%
9/160 • Number of events 9 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
5.2%
8/155 • Number of events 9 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
3.8%
1/26 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
6.7%
6/89 • Number of events 6 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
13.1%
23/175 • Number of events 25 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
General disorders
Injection site reaction
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
10.3%
16/155 • Number of events 24 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
3.4%
3/89 • Number of events 3 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
10.9%
19/175 • Number of events 27 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
9/160 • Number of events 9 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
5.2%
8/155 • Number of events 8 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
9.0%
8/89 • Number of events 13 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
12.0%
21/175 • Number of events 30 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
10/160 • Number of events 10 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
2.6%
4/155 • Number of events 5 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
3.8%
1/26 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
5.6%
5/89 • Number of events 6 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
10.3%
18/175 • Number of events 22 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
3/160 • Number of events 3 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.9%
3/155 • Number of events 3 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
7.7%
2/26 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
1/89 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
5.1%
9/175 • Number of events 9 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Endocrine disorders
Hypothyroidism
|
3.8%
6/160 • Number of events 6 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
11.5%
3/26 • Number of events 3 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
3.4%
3/89 • Number of events 3 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
7.4%
13/175 • Number of events 13 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
General disorders
Fatigue
|
3.8%
6/160 • Number of events 6 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
4.5%
7/155 • Number of events 7 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
7.7%
2/26 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
1/89 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
8.0%
14/175 • Number of events 16 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Infections and infestations
Bronchitis
|
1.9%
3/160 • Number of events 3 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
6.7%
6/89 • Number of events 6 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
5.1%
9/175 • Number of events 9 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Infections and infestations
COVID-19
|
1.9%
3/160 • Number of events 3 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.3%
2/155 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
7.7%
2/26 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
4.5%
4/89 • Number of events 4 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
6.3%
11/175 • Number of events 11 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/160 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.65%
1/155 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
7.7%
2/26 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/89 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.7%
3/175 • Number of events 3 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
3/160 • Number of events 3 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
7.7%
2/26 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
3.4%
3/89 • Number of events 4 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
4.0%
7/175 • Number of events 9 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Investigations
Blood creatinine increased
|
2.5%
4/160 • Number of events 5 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
2.6%
4/155 • Number of events 4 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
7.7%
2/26 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
6.7%
6/89 • Number of events 6 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
8.6%
15/175 • Number of events 17 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.9%
3/160 • Number of events 3 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
3.2%
5/155 • Number of events 5 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
7.7%
2/26 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.1%
1/89 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
5.7%
10/175 • Number of events 11 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
6/160 • Number of events 8 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.9%
3/155 • Number of events 3 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/26 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
7.9%
7/89 • Number of events 7 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
8.6%
15/175 • Number of events 18 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
5/160 • Number of events 5 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
3.9%
6/155 • Number of events 6 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
7.7%
2/26 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
3.4%
3/89 • Number of events 3 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
9.1%
16/175 • Number of events 16 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
2/160 • Number of events 3 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
1.3%
2/155 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
3.8%
1/26 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
5.6%
5/89 • Number of events 5 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
5.1%
9/175 • Number of events 11 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Nervous system disorders
Dizziness
|
0.62%
1/160 • Number of events 1 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
0.00%
0/155 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
7.7%
2/26 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
2.2%
2/89 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
2.9%
5/175 • Number of events 5 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.4%
7/160 • Number of events 7 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
4.5%
7/155 • Number of events 7 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
7.7%
2/26 • Number of events 2 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
7.9%
7/89 • Number of events 7 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
12.0%
21/175 • Number of events 23 • Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
|
Additional Information
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