Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer · Source last updated 2023-02-17
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 60 months). Cycle length=21 days.
What was measured
Percentage of participants with deterioration in patient-reported function and HRQoL, defined as \>= 10 points decrease from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.
Analysis population: PRO-evaluable population is defined as patients in the ITT population with a baseline and \>=1 post-baseline PRO assessment.
Groups in this outcome
Placebo With Paclitaxel, Carboplatin and Bevacizumab
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
473
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
473
Reported measurements
Physical Functioning, Cycle 3 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
456
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
444
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
24.1
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
24.1
Not reported
Not reported
Not reported
Not reported
Physical Functioning, Cycle 5 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
439
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
423
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
27.1
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
28.6
Not reported
Not reported
Not reported
Not reported
Physical Functioning, Cycle 8 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
414
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
403
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
23.4
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
23.6
Not reported
Not reported
Not reported
Not reported
Physical Functioning, Cycle 12 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
378
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
358
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
17.2
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
16.5
Not reported
Not reported
Not reported
Not reported
Physical Functioning, Cycle 16 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
333
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
312
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
17.1
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
17.0
Not reported
Not reported
Not reported
Not reported
Physical Functioning, Cycle 20 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
253
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
234
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
18.2
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
16.7
Not reported
Not reported
Not reported
Not reported
Physical Functioning, Completion of Treatment/ Early Termination Visit
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
370
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
366
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
20.5
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
25.1
Not reported
Not reported
Not reported
Not reported
Physical Functioning, Post-Treatment Follow Up 3 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
235
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
236
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
22.6
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
23.7
Not reported
Not reported
Not reported
Not reported
Physical Functioning, Post-Treatment Follow Up 6 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
147
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
164
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
24.5
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
25.0
Not reported
Not reported
Not reported
Not reported
Physical Functioning, Post-Treatment Follow Up 9 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
84
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
98
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
19.0
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
25.5
Not reported
Not reported
Not reported
Not reported
Physical Functioning, Post-Treatment Follow Up 12 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
45
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
58
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
17.8
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
25.9
Not reported
Not reported
Not reported
Not reported
Physical Functioning, Post-Treatment Follow Up 18 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
14
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
16
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
21.4
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
25.0
Not reported
Not reported
Not reported
Not reported
Physical Functioning, Post-Treatment Follow Up 24 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
2
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
6
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
0
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
50
Not reported
Not reported
Not reported
Not reported
Role Functioning, Cycle 3 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
455
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
443
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
21.3
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
27.8
Not reported
Not reported
Not reported
Not reported
Role Functioning, Cycle 5 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
438
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
422
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
26.7
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
27.0
Not reported
Not reported
Not reported
Not reported
Role Functioning, Cycle 8 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
413
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
401
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
21.1
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
22.7
Not reported
Not reported
Not reported
Not reported
Role Functioning, Cycle 12 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
377
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
358
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
16.7
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
16.8
Not reported
Not reported
Not reported
Not reported
Role Functioning, Cycle 16 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
333
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
311
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
20.1
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
15.8
Not reported
Not reported
Not reported
Not reported
Role Functioning, Cycle 20 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
253
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
233
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
18.6
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
13.3
Not reported
Not reported
Not reported
Not reported
Role Functioning, Completion of Treatment/ Early Termination Visit
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
370
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
367
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
23.0
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
24.3
Not reported
Not reported
Not reported
Not reported
Role Functioning, Post-Treatment Follow Up 3 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
235
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
236
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
20.9
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
27.1
Not reported
Not reported
Not reported
Not reported
Role Functioning, Post-Treatment Follow Up 6 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
147
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
164
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
20.4
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
25.6
Not reported
Not reported
Not reported
Not reported
Role Functioning, Post-Treatment Follow Up 9 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
84
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
98
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
19.0
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
26.5
Not reported
Not reported
Not reported
Not reported
Role Functioning, Post-Treatment Follow Up 12 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
45
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
58
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
6.7
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
37.9
Not reported
Not reported
Not reported
Not reported
Role Functioning, Post-Treatment Follow Up 18 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
14
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
16
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
7.1
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
31.3
Not reported
Not reported
Not reported
Not reported
Role Functioning, Post-Treatment Follow Up 24 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
2
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
6
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
0
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
16.7
Not reported
Not reported
Not reported
Not reported
Social Functioning, Cycle 3 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
455
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
442
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
29.0
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
31.2
Not reported
Not reported
Not reported
Not reported
Social Functioning, Cycle 5 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
439
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
422
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
29.6
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
30.6
Not reported
Not reported
Not reported
Not reported
Social Functioning, Cycle 8 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
413
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
403
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
21.8
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
25.8
Not reported
Not reported
Not reported
Not reported
Social Functioning, Cycle 12 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
376
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
357
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
18.9
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
19.0
Not reported
Not reported
Not reported
Not reported
Social Functioning, Cycle 16 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
333
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
312
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
19.5
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
17.6
Not reported
Not reported
Not reported
Not reported
Social Functioning, Cycle 20 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
252
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
234
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
20.2
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
16.2
Not reported
Not reported
Not reported
Not reported
Social Functioning, Completion of Treatment/ Early Termination Visit
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
367
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
367
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
27.2
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
28.1
Not reported
Not reported
Not reported
Not reported
Social Functioning, Post-Treatment Follow Up 3 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
234
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
236
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
26.5
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
25.4
Not reported
Not reported
Not reported
Not reported
Social Functioning, Post-Treatment Follow Up 6 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
148
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
164
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
23.0
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
30.5
Not reported
Not reported
Not reported
Not reported
Social Functioning, Post-Treatment Follow Up 9 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
84
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
98
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
22.6
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
32.7
Not reported
Not reported
Not reported
Not reported
Social Functioning, Post-Treatment Follow Up 12 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
45
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
58
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
8.9
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
37.9
Not reported
Not reported
Not reported
Not reported
Social Functioning, Post-Treatment Follow Up 18 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
14
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
16
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
14.3
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
37.5
Not reported
Not reported
Not reported
Not reported
Social Functioning, Post-Treatment Follow Up 24 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
2
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
6
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
0
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
33.3
Not reported
Not reported
Not reported
Not reported
Emotional Functioning, Cycle 3 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
454
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
443
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
12.8
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
14.0
Not reported
Not reported
Not reported
Not reported
Emotional Functioning, Cycle 5 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
439
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
422
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
17.3
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
15.9
Not reported
Not reported
Not reported
Not reported
Emotional Functioning, Cycle 8 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
412
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
403
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
14.6
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
12.4
Not reported
Not reported
Not reported
Not reported
Emotional Functioning, Cycle 12 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
376
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
357
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
12.2
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
13.4
Not reported
Not reported
Not reported
Not reported
Emotional Functioning, Cycle 16 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
333
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
312
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
13.2
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
12.5
Not reported
Not reported
Not reported
Not reported
Emotional Functioning, Cycle 20 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
252
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
234
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
15.5
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
11.1
Not reported
Not reported
Not reported
Not reported
Emotional Functioning, Completion of Treatment/ Early Termination Visit
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
368
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
367
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
19.3
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
19.3
Not reported
Not reported
Not reported
Not reported
Emotional Functioning, Post-Treatment Follow Up 3 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
234
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
236
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
19.7
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
16.9
Not reported
Not reported
Not reported
Not reported
Emotional Functioning, Post-Treatment Follow Up 6 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
148
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
164
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
20.9
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
14.6
Not reported
Not reported
Not reported
Not reported
Emotional Functioning, Post-Treatment Follow Up 9 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
84
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
98
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
8.3
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
18.4
Not reported
Not reported
Not reported
Not reported
Emotional Functioning, Post-Treatment Follow Up 12 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
45
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
58
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
8.9
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
22.4
Not reported
Not reported
Not reported
Not reported
Emotional Functioning, Post-Treatment Follow Up 18 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
14
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
16
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
7.1
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
31.3
Not reported
Not reported
Not reported
Not reported
Emotional Functioning, Post-Treatment Follow Up 24 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
2
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
6
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
0
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
66.7
Not reported
Not reported
Not reported
Not reported
GHS/OoL Function, Cycle 3 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
455
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
443
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
24.2
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
22.8
Not reported
Not reported
Not reported
Not reported
GHS/OoL Function, Cycle 5 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
439
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
422
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
24.1
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
23.7
Not reported
Not reported
Not reported
Not reported
GHS/OoL Function, Cycle 8 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
413
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
403
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
21.3
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
18.1
Not reported
Not reported
Not reported
Not reported
GHS/OoL Function, Cycle 12 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
376
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
357
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
17.6
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
13.2
Not reported
Not reported
Not reported
Not reported
GHS/OoL Function, Cycle 16 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
333
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
312
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
18.3
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
13.5
Not reported
Not reported
Not reported
Not reported
GHS/OoL Function, Cycle 20 Day 1
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
252
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
234
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
20.2
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
11.1
Not reported
Not reported
Not reported
Not reported
GHS/OoL Function, Completion of Treatment/ Early Termination Visit
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
368
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
367
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
24.5
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
24.3
Not reported
Not reported
Not reported
Not reported
GHS/OoL Function, Post-Treatment Follow Up 3 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
234
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
236
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
20.5
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
22.9
Not reported
Not reported
Not reported
Not reported
GHS/OoL Function, Post-Treatment Follow Up 6 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
148
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
164
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
20.9
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
23.8
Not reported
Not reported
Not reported
Not reported
GHS/OoL Function, Post-Treatment Follow Up 9 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
84
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
98
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
21.4
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
25.5
Not reported
Not reported
Not reported
Not reported
GHS/OoL Function, Post-Treatment Follow Up 12 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
45
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
58
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
17.8
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
34.5
Not reported
Not reported
Not reported
Not reported
GHS/OoL Function, Post-Treatment Follow Up 18 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
14
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
16
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
21.4
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
43.8
Not reported
Not reported
Not reported
Not reported
GHS/OoL Function, Post-Treatment Follow Up 24 Months
Analysis denominator · Participants
Group
Source count
Placebo With Paclitaxel, Carboplatin and Bevacizumab
2
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
6
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo With Paclitaxel, Carboplatin and Bevacizumab
0
Not reported
Not reported
Not reported
Not reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
50.0
Not reported
Not reported
Not reported
Not reported
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
ci Lower Limit
0.75
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.63
group Description
Emotional functioning, Cycle 3 Day 1
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.6063
param Type
Odds Ratio (OR)
param Value
1.11
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.63
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.29
group Description
Emotional functioning, Cycle 5 Day 1
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.5739
param Type
Odds Ratio (OR)
param Value
0.90
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.56
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.25
group Description
Emotional functioning, Cycle 8 Day 1
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.3792
param Type
Odds Ratio (OR)
param Value
0.84
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.73
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.73
group Description
Emotional functioning, Cycle 12 Day 1
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.6022
param Type
Odds Ratio (OR)
param Value
1.12
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.59
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.49
group Description
Emotional functioning, Cycle 16 Day 1
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.7893
param Type
Odds Ratio (OR)
param Value
0.94
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.42
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.22
group Description
Emotional functioning, Cycle 20 Day 1
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.2125
param Type
Odds Ratio (OR)
param Value
0.71
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.70
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.46
group Description
Emotional functioning, Completion of Treatment/ Early Termination Visit
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.9661
param Type
Odds Ratio (OR)
param Value
1.01
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.52
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.32
group Description
Emotional functioning, Post-Treatment Follow Up 3 Months
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.4299
param Type
Odds Ratio (OR)
param Value
0.83
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.36
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.18
group Description
Emotional functioning, Post-Treatment Follow Up 6 Months
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.1542
param Type
Odds Ratio (OR)
param Value
0.65
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
1.04
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
6.76
group Description
Emotional functioning, Post-Treatment Follow Up 9 Months
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.0363
param Type
Odds Ratio (OR)
param Value
2.65
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.85
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
8.93
group Description
Emotional functioning, Post-Treatment Follow Up 12 Months
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.0814
param Type
Odds Ratio (OR)
param Value
2.75
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.43
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
38.00
group Description
Emotional functioning, Post-Treatment Follow Up 18 Months
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.1915
param Type
Odds Ratio (OR)
param Value
4.03
statistical Method
Cochran-Mantel-Haenszel
Complete source fields
analyses
ci Lower Limit
0.75
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.63
group Description
Emotional functioning, Cycle 3 Day 1
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.6063
param Type
Odds Ratio (OR)
param Value
1.11
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.63
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.29
group Description
Emotional functioning, Cycle 5 Day 1
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.5739
param Type
Odds Ratio (OR)
param Value
0.90
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.56
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.25
group Description
Emotional functioning, Cycle 8 Day 1
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.3792
param Type
Odds Ratio (OR)
param Value
0.84
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.73
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.73
group Description
Emotional functioning, Cycle 12 Day 1
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.6022
param Type
Odds Ratio (OR)
param Value
1.12
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.59
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.49
group Description
Emotional functioning, Cycle 16 Day 1
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.7893
param Type
Odds Ratio (OR)
param Value
0.94
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.42
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.22
group Description
Emotional functioning, Cycle 20 Day 1
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.2125
param Type
Odds Ratio (OR)
param Value
0.71
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.70
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.46
group Description
Emotional functioning, Completion of Treatment/ Early Termination Visit
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.9661
param Type
Odds Ratio (OR)
param Value
1.01
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.52
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.32
group Description
Emotional functioning, Post-Treatment Follow Up 3 Months
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.4299
param Type
Odds Ratio (OR)
param Value
0.83
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.36
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.18
group Description
Emotional functioning, Post-Treatment Follow Up 6 Months
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.1542
param Type
Odds Ratio (OR)
param Value
0.65
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
1.04
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
6.76
group Description
Emotional functioning, Post-Treatment Follow Up 9 Months
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.0363
param Type
Odds Ratio (OR)
param Value
2.65
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.85
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
8.93
group Description
Emotional functioning, Post-Treatment Follow Up 12 Months
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.0814
param Type
Odds Ratio (OR)
param Value
2.75
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.43
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
38.00
group Description
Emotional functioning, Post-Treatment Follow Up 18 Months
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.1915
param Type
Odds Ratio (OR)
param Value
4.03
statistical Method
Cochran-Mantel-Haenszel
classes
categories
measurements
group Id
OG000
value
24.1
group Id
OG001
value
24.1
denoms
counts
group Id
OG000
value
456
group Id
OG001
value
444
units
Participants
title
Physical Functioning, Cycle 3 Day 1
categories
measurements
group Id
OG000
value
27.1
group Id
OG001
value
28.6
denoms
counts
group Id
OG000
value
439
group Id
OG001
value
423
units
Participants
title
Physical Functioning, Cycle 5 Day 1
categories
measurements
group Id
OG000
value
23.4
group Id
OG001
value
23.6
denoms
counts
group Id
OG000
value
414
group Id
OG001
value
403
units
Participants
title
Physical Functioning, Cycle 8 Day 1
categories
measurements
group Id
OG000
value
17.2
group Id
OG001
value
16.5
denoms
counts
group Id
OG000
value
378
group Id
OG001
value
358
units
Participants
title
Physical Functioning, Cycle 12 Day 1
categories
measurements
group Id
OG000
value
17.1
group Id
OG001
value
17.0
denoms
counts
group Id
OG000
value
333
group Id
OG001
value
312
units
Participants
title
Physical Functioning, Cycle 16 Day 1
categories
measurements
group Id
OG000
value
18.2
group Id
OG001
value
16.7
denoms
counts
group Id
OG000
value
253
group Id
OG001
value
234
units
Participants
title
Physical Functioning, Cycle 20 Day 1
categories
measurements
group Id
OG000
value
20.5
group Id
OG001
value
25.1
denoms
counts
group Id
OG000
value
370
group Id
OG001
value
366
units
Participants
title
Physical Functioning, Completion of Treatment/ Early Termination Visit
categories
measurements
group Id
OG000
value
22.6
group Id
OG001
value
23.7
denoms
counts
group Id
OG000
value
235
group Id
OG001
value
236
units
Participants
title
Physical Functioning, Post-Treatment Follow Up 3 Months
categories
measurements
group Id
OG000
value
24.5
group Id
OG001
value
25.0
denoms
counts
group Id
OG000
value
147
group Id
OG001
value
164
units
Participants
title
Physical Functioning, Post-Treatment Follow Up 6 Months
categories
measurements
group Id
OG000
value
19.0
group Id
OG001
value
25.5
denoms
counts
group Id
OG000
value
84
group Id
OG001
value
98
units
Participants
title
Physical Functioning, Post-Treatment Follow Up 9 Months
categories
measurements
group Id
OG000
value
17.8
group Id
OG001
value
25.9
denoms
counts
group Id
OG000
value
45
group Id
OG001
value
58
units
Participants
title
Physical Functioning, Post-Treatment Follow Up 12 Months
categories
measurements
group Id
OG000
value
21.4
group Id
OG001
value
25.0
denoms
counts
group Id
OG000
value
14
group Id
OG001
value
16
units
Participants
title
Physical Functioning, Post-Treatment Follow Up 18 Months
denoms
counts
group Id
OG000
value
473
group Id
OG001
value
473
units
Participants
description
Percentage of participants with deterioration in patient-reported function and HRQoL, defined as \>= 10 points decrease from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.
groups
description
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
id
OG000
title
Placebo With Paclitaxel, Carboplatin and Bevacizumab
description
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
id
OG001
title
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
param Type
NUMBER
population Description
PRO-evaluable population is defined as patients in the ITT population with a baseline and \>=1 post-baseline PRO assessment.
reporting Status
POSTED
time Frame
From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 60 months). Cycle length=21 days.
title
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Triangle