Trial Outcomes & Findings for A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) (NCT NCT03125902)
NCT ID: NCT03125902
Last Updated: 2024-03-26
Results Overview
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
653 participants
Primary outcome timeframe
From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)
Results posted on
2024-03-26
Participant Flow
The target population included subjects with previously untreated inoperable locally advanced or metastatic TNBC.
Participant milestones
| Measure |
Placebo + Paclitaxel
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab + Paclitaxel
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
220
|
431
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
220
|
431
|
Reasons for withdrawal
| Measure |
Placebo + Paclitaxel
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab + Paclitaxel
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Death
|
119
|
229
|
|
Overall Study
Lost to Follow-up
|
4
|
13
|
|
Overall Study
Other
|
0
|
4
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Progressive Disease
|
0
|
3
|
|
Overall Study
Study Terminated By Sponsor
|
74
|
143
|
|
Overall Study
Withdrawal by Subject
|
21
|
37
|
Baseline Characteristics
A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
Baseline characteristics by cohort
| Measure |
Placebo and Paclitaxel
n=220 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=431 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Total
n=651 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
176 Participants
n=5 Participants
|
322 Participants
n=7 Participants
|
498 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
44 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Age, Continuous
|
52.7 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
54.8 Years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
54.0 Years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
220 Participants
n=5 Participants
|
430 Participants
n=7 Participants
|
650 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
174 Participants
n=5 Participants
|
332 Participants
n=7 Participants
|
506 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
66 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
128 Participants
n=5 Participants
|
246 Participants
n=7 Participants
|
374 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)Population: PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Outcome measures
| Measure |
Placebo and Paclitaxel
n=101 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=191 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Subpopulation With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status
|
5.72 Months
Interval 5.39 to 7.2
|
5.95 Months
Interval 5.62 to 7.43
|
PRIMARY outcome
Timeframe: From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)Population: ITT population: all randomized participants, whether or not the assigned study treatment was received
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Outcome measures
| Measure |
Placebo and Paclitaxel
n=220 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=431 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population
|
5.55 Months
Interval 5.36 to 6.51
|
5.68 Months
Interval 5.42 to 7.16
|
SECONDARY outcome
Timeframe: From Day 1 to death from any cause, assessed up 36 monthsPopulation: PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization
OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.
Outcome measures
| Measure |
Placebo and Paclitaxel
n=101 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=191 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS) in the PD-L1-Positive Subpopulation
|
28.29 Months
Interval 19.06 to
Upper limit not determined due to insufficient number of participants with events
|
22.05 Months
Interval 19.19 to 30.52
|
SECONDARY outcome
Timeframe: From Day 1 to death from any cause, assessed up to end of study (up to approximately 36 months)Population: ITT population: all randomized participants, whether or not the assigned study treatment was received
OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.
Outcome measures
| Measure |
Placebo and Paclitaxel
n=220 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=431 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS) in the ITT Population
|
22.80 Months
Interval 17.08 to 28.29
|
19.19 Months
Interval 16.59 to 22.05
|
SECONDARY outcome
Timeframe: From Day 1 to death from any cause, assessed up to 12 and 18 monthsPopulation: ITT population: all randomized participants, whether or not the assigned study treatment was received
Outcome measures
| Measure |
Placebo and Paclitaxel
n=220 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=431 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants Who Are Alive at 12 and 18 Months
12 months
|
73.47 Percentage of Participants
Interval 67.44 to 79.49
|
68.86 Percentage of Participants
Interval 64.37 to 73.34
|
|
Percentage of Participants Who Are Alive at 12 and 18 Months
18 months
|
56.18 Percentage of Participants
Interval 48.94 to 63.42
|
52.32 Percentage of Participants
Interval 47.15 to 57.48
|
SECONDARY outcome
Timeframe: From Day 1 to deterioration, assessed up 64 monthsPopulation: PRO-evaluable populations: participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the questionnaire of interest (European Organization for the Research and Treatment of Cancer \[EORTC\] Quality-of-life Questionnaire \[QLQ\] C30, EORTC QLQ BR-23 or FACT-G)
Deterioration in Global Health Status/HRQoL is defined as a decrease of at least 10 points on the Global Health Status /HRQoL scale (comprised of 2 items: 29 and 30) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The 2 items use 7-point scale (1 = very poor to 7 = Excellent). Scores are averaged, transformed to 0-100 scale; where higher score=better level of functioning or greater degree of symptoms.
Outcome measures
| Measure |
Placebo and Paclitaxel
n=205 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=384 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Time to Deterioration (TTD) in Global Health Status/ Health Related Quality of Life (HRQoL) in the PRO Evaluable Population
|
17.35 Months
Interval 9.23 to
Upper limit was not reached due to not sufficient number of participants with event.
|
28.68 Months
Interval 11.99 to
Upper limit was not reached due to not sufficient number of participants with event.
|
SECONDARY outcome
Timeframe: From Day 1 to PD or death from any cause, assessed up to 12 monthsPopulation: ITT population: all randomized participants, whether or not the assigned study treatment was received
PD is defined as \>/=20% relative increase and \>/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Outcome measures
| Measure |
Placebo and Paclitaxel
n=220 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=431 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants Who Are Alive Without Progression Event at Month 12 Assessed Using RECIST v1.1
|
16.22 Percentage of Participants
Interval 10.18 to 22.26
|
21.63 Percentage of Participants
Interval 16.74 to 26.51
|
SECONDARY outcome
Timeframe: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)Population: PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization
Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (\<) 10mm for nodal TLs/ non-TLs. PR is defined as \>/=30% decrease in SD of TLs, taking as reference the baseline SD. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later.
Outcome measures
| Measure |
Placebo and Paclitaxel
n=101 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=191 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Confirmed, Investigator-Assessed )
|
40.6 Percentage of Participants
Interval 30.93 to 50.82
|
49.2 Percentage of Participants
Interval 41.92 to 56.53
|
SECONDARY outcome
Timeframe: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)Population: PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization
Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (\<) 10mm for nodal TLs/ non-TLs. PR is defined as \>/=30% decrease in SD of TLs, taking as reference the baseline SD.
Outcome measures
| Measure |
Placebo and Paclitaxel
n=101 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=191 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Unconfirmed, Investigator-Assessed)
|
55.4 Percentage of Participants
Interval 45.22 to 65.34
|
63.4 Percentage of Participants
Interval 56.09 to 70.19
|
SECONDARY outcome
Timeframe: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)Population: Response-evaluable population: participants in the ITT population with measurable disease at baseline
Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (\<) 10mm for nodal TLs/ non-TLs. PR is defined as \>/=30% decrease in SD of TLs, taking as reference the baseline SD. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later.
Outcome measures
| Measure |
Placebo and Paclitaxel
n=219 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=431 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Confirmed, Investigator-Assessed )
|
32.4 Percentage of Participants
Interval 26.27 to 39.05
|
39.9 Percentage of Participants
Interval 35.25 to 44.7
|
SECONDARY outcome
Timeframe: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)Population: Response-evaluable population: participants in the ITT population with measurable disease at baseline
Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (\<) 10mm for nodal TLs/ non-TLs. PR is defined as \>/=30% decrease in SD of TLs, taking as reference the baseline SD.
Outcome measures
| Measure |
Placebo and Paclitaxel
n=219 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=431 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Unconfirmed, Investigator-Assessed )
|
47.5 Percentage of Participants
Interval 40.72 to 54.33
|
53.6 Percentage of Participants
Interval 48.76 to 58.38
|
SECONDARY outcome
Timeframe: From objective response to PD, assessed up to primary completion date (approximately 26 months)Population: Duration of response (DoR)-evaluable population: participants in the ITT population with measurable disease at baseline
DOR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first. CR is defined as the disappearance of all TLs and SA reduction to \<10mm for nodal TLs/ non-TLs. PR is defined as \>/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as \>/=20% relative increase and \>/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Outcome measures
| Measure |
Placebo and Paclitaxel
n=104 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=231 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Duration of Objective Response (DOR) Assessed Using RECIST v1.1 in DOR-evaluable Population (Unconfirmed)
|
5.45 Months
Interval 4.67 to 6.31
|
6.41 Months
Interval 5.55 to 7.39
|
SECONDARY outcome
Timeframe: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)Population: Clinical Benefit Rate analysis included all participants with unconfirmed PR/CR or SD of at least 6 months duration
Clinical benefit is defined as the achievement of CR, PR, or stable disease according to RECIST v1.1 that lasts for at least 6 months. CR is defined as the disappearance of all TLs and SA reduction to \<10mm for nodal TLs/ non-TLs. PR is defined as \>/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as \>/=20% relative increase and \>/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference smallest SD since treatment started.
Outcome measures
| Measure |
Placebo and Paclitaxel
n=219 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=431 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants With Clinical Benefit Assessed Using RECIST v1.1 in Response-evaluable Population
|
49.8 Percentage of Participants
Interval 42.96 to 56.59
|
57.1 Percentage of Participants
Interval 52.25 to 61.8
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours) on Day 1 of Cycles 2-4 and at treatment discontinuation (TD), (approximately 9 months).Population: PK-evaluable population: all participants who received any dose of Atezolizumab and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.
Outcome measures
| Measure |
Placebo and Paclitaxel
n=342 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Minimum Observed Serum Concentration (Cmin) of Atezolizumab in PK Evaluable Population
C2D1 predose
|
139 μg/mL
Standard Deviation 53.3
|
—
|
|
Minimum Observed Serum Concentration (Cmin) of Atezolizumab in PK Evaluable Population
C3D1 predose
|
208 μg/mL
Standard Deviation 78.3
|
—
|
|
Minimum Observed Serum Concentration (Cmin) of Atezolizumab in PK Evaluable Population
C4D1 predose
|
242 μg/mL
Standard Deviation 84.8
|
—
|
SECONDARY outcome
Timeframe: C1D1 30 min postdosePopulation: PK-evaluable population: all participants who received any dose of Atezolizumab and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.
Outcome measures
| Measure |
Placebo and Paclitaxel
n=308 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Atezolizumab in PK-evaluable Population
|
321 μg/mL
Standard Deviation 90.5
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours) on Day 1 of Cycle 3 (1 Cycle = 28 days)Population: PK-evaluable population: first 60 participants who received any dose of Paclitaxel and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.
Outcome measures
| Measure |
Placebo and Paclitaxel
n=18 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=29 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Minimum Observed Plasma Concentration (Cmin) of Paclitaxel
|
1.51 ng/mL
Geometric Coefficient of Variation NA
Insufficient number of samples analyzed.
|
1.67 ng/mL
Geometric Coefficient of Variation NA
Insufficient number of samples analyzed.
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours), 5-10 min before and after paclitaxel infusion, 60 min after paclitaxel infusion on Day 1 of Cycles 1 and 3 (paclitaxel infusion duration= 60 min) (1 Cycle = 28 days)Population: PK-evaluable population: first 60 participants who received any dose of Paclitaxel and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.
Outcome measures
| Measure |
Placebo and Paclitaxel
n=23 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=36 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Paclitaxel
C1D1 Post-Dose
|
518 ng/mL
Geometric Coefficient of Variation 290.7
|
301 ng/mL
Geometric Coefficient of Variation 1501
|
|
Maximum Observed Plasma Concentration (Cmax) of Paclitaxel
C3D1 Post-Dose
|
666 ng/mL
Geometric Coefficient of Variation 339
|
276 ng/mL
Geometric Coefficient of Variation 1360
|
SECONDARY outcome
Timeframe: From Day 1 From baseline up to 64 monthsPopulation: Safety-evaluable population: participants who received any amount of any study drug. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.
Investigator text for AEs is coded using MedDRA version 25.1
Outcome measures
| Measure |
Placebo and Paclitaxel
n=217 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=432 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Percentage of participants with at least one AE
|
97.7 Percentage of participants
|
99.1 Percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Percentage of participants with at least one SAE
|
18.4 Percentage of participants
|
25.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16, and at every 8 cycles thereafter until TD, at TD, and at 90-150 days after TD (maximum up to 45 months) (1 Cycle = 28 days)Population: Anti-Drug Antibody (ADA) population: * Baseline ADA-evaluable population: all participants with at least one evaluable ADA assay result from a baseline sample * Post baseline ADA-Evaluable population: all participants with at least one evaluable ADA assay result from at least one post-baseline sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.
Outcome measures
| Measure |
Placebo and Paclitaxel
n=334 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants With Anti-Drug Antibodies' (ADAs) Against Atezolizumab in ADA Evaluable Population
Percentage of participants positive for ADA at Baseline
|
1.5 Percentage of Participants
|
—
|
|
Percentage of Participants With Anti-Drug Antibodies' (ADAs) Against Atezolizumab in ADA Evaluable Population
Percentage of participants positive for ADA Post-baseline
|
14.7 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to 66 monthsPopulation: ITT population: all randomized participants, whether or not the assigned study treatment was received
Outcome measures
| Measure |
Placebo and Paclitaxel
n=220 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=431 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival by PD-L1 Status, Intent to Treat Population
PD-L1 IC0
|
20.30 Months
Interval 14.72 to 25.1
|
16.30 Months
Interval 14.52 to 19.65
|
|
Overall Survival by PD-L1 Status, Intent to Treat Population
PD-L1 IC1/2/3
|
28.29 Months
Interval 19.06 to
Upper limit not determined due to insufficient number of participants with events
|
22.05 Months
Interval 19.19 to 30.52
|
SECONDARY outcome
Timeframe: From Day 1 up to primary completion date (approximately 26 months)Population: ITT population: all randomized participants, whether or not the assigned study treatment was received
Outcome measures
| Measure |
Placebo and Paclitaxel
n=220 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=431 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression Free Survival by PD-L1 Status, Intent to Treat Population
PD-L1 IC0
|
5.49 Months
Interval 3.84 to 6.51
|
5.45 Months
Interval 4.6 to 6.51
|
|
Progression Free Survival by PD-L1 Status, Intent to Treat Population
PD-L1 IC1/2/3
|
5.72 Months
Interval 5.39 to 7.2
|
5.95 Months
Interval 5.62 to 7.43
|
SECONDARY outcome
Timeframe: From objective response to PD, assessed up to primary completion date (approximately 26 months)Population: Duration of confirmed response (C-DoR)-evaluable population: participants in the ITT population with measurable disease at baseline and with a confirmed objective response
C-DoR is defined as the time from the first occurrence of a documented confirmed response (CR or PR) in C-DOR evaluable population until the date of disease progression per RECIST v1.1 or death from any cause, whichever occurs first. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later.
Outcome measures
| Measure |
Placebo and Paclitaxel
n=71 Participants
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Atezolizumab and Paclitaxel
n=172 Participants
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Duration of Confirmed Response (C-DoR) in (C-DoR)-Evaluable Population
|
5.75 Months
Interval 5.36 to 7.56
|
7.66 Months
Interval 7.16 to 11.33
|
Adverse Events
Atezolizumab + Paclitaxel
Serious events: 112 serious events
Other events: 421 other events
Deaths: 229 deaths
Placebo + Paclitaxel
Serious events: 40 serious events
Other events: 209 other events
Deaths: 119 deaths
Serious adverse events
| Measure |
Atezolizumab + Paclitaxel
n=431 participants at risk
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Placebo + Paclitaxel
n=220 participants at risk
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Infections and infestations
GASTROENTERITIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Infections and infestations
INFECTION
|
0.00%
0/431 • From baseline up to 64 months
|
0.91%
2/220 • Number of events 2 • From baseline up to 64 months
|
|
Infections and infestations
DIVERTICULITIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Infections and infestations
ERYSIPELAS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.46%
2/431 • Number of events 2 • From baseline up to 64 months
|
0.91%
2/220 • Number of events 2 • From baseline up to 64 months
|
|
Blood and lymphatic system disorders
BICYTOPENIA
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.70%
3/431 • Number of events 3 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Blood and lymphatic system disorders
LYMPHADENITIS
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.46%
2/431 • Number of events 2 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.46%
1/217 • Number of events 1 • From baseline up to 64 months
|
|
Cardiac disorders
PERICARDITIS
|
0.00%
0/431 • From baseline up to 64 months
|
0.46%
1/217 • Number of events 1 • From baseline up to 64 months
|
|
Ear and labyrinth disorders
VERTIGO
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Endocrine disorders
HYPOPHYSITIS
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Eye disorders
KERATITIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Eye disorders
ORBITAL MYOSITIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Gastrointestinal disorders
COLITIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.46%
2/431 • Number of events 2 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL ULCER
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Gastrointestinal disorders
IMMUNE-MEDIATED PANCREATITIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Gastrointestinal disorders
NAUSEA
|
0.46%
2/431 • Number of events 2 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.46%
2/431 • Number of events 3 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Gastrointestinal disorders
VOMITING
|
0.70%
3/431 • Number of events 3 • From baseline up to 64 months
|
1.4%
3/220 • Number of events 3 • From baseline up to 64 months
|
|
General disorders
DEATH
|
0.93%
4/431 • Number of events 4 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
General disorders
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
General disorders
PYREXIA
|
0.93%
4/431 • Number of events 4 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Hepatobiliary disorders
HEPATITIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Infections and infestations
BRONCHITIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Infections and infestations
DIARRHOEA INFECTIOUS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Infections and infestations
INFLUENZA
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Infections and infestations
MYELITIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Infections and infestations
PNEUMOCYSTIS JIROVECII PNEUMONIA
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Infections and infestations
PNEUMONIA
|
2.6%
11/431 • Number of events 11 • From baseline up to 64 months
|
1.8%
4/220 • Number of events 4 • From baseline up to 64 months
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Infections and infestations
PULMONARY SEPSIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Infections and infestations
PYELONEPHRITIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Infections and infestations
SEPSIS
|
0.93%
4/431 • Number of events 4 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Infections and infestations
SOFT TISSUE INFECTION
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Infections and infestations
STAPHYLOCOCCAL SKIN INFECTION
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Infections and infestations
TOOTH INFECTION
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.70%
3/431 • Number of events 4 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Infections and infestations
UROSEPSIS
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Infections and infestations
VASCULAR DEVICE INFECTION
|
0.46%
2/431 • Number of events 2 • From baseline up to 64 months
|
1.4%
3/220 • Number of events 3 • From baseline up to 64 months
|
|
Infections and infestations
VESTIBULAR NEURONITIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Infections and infestations
WOUND INFECTION
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Injury, poisoning and procedural complications
COMPRESSION FRACTURE
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.46%
2/431 • Number of events 2 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.70%
3/431 • Number of events 4 • From baseline up to 64 months
|
0.91%
2/220 • Number of events 2 • From baseline up to 64 months
|
|
Injury, poisoning and procedural complications
PROCEDURAL PNEUMOTHORAX
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.46%
2/431 • Number of events 2 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.46%
2/431 • Number of events 2 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Metabolism and nutrition disorders
HYPERAMYLASAEMIA
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Metabolism and nutrition disorders
HYPERLIPASAEMIA
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Metabolism and nutrition disorders
HYPOPROTEINAEMIA
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 2 • From baseline up to 64 months
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.46%
2/431 • Number of events 2 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.46%
2/431 • Number of events 2 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.46%
2/431 • Number of events 2 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Musculoskeletal and connective tissue disorders
POLYMYOSITIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Nervous system disorders
CEREBRAL VENOUS SINUS THROMBOSIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Nervous system disorders
HEADACHE
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Nervous system disorders
MYASTHENIA GRAVIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Nervous system disorders
SEIZURE
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Product Issues
DEVICE BREAKAGE
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Product Issues
DEVICE KINK
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.46%
2/431 • Number of events 2 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Renal and urinary disorders
GLOMERULONEPHRITIS CHRONIC
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Renal and urinary disorders
NEPHRITIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.23%
1/431 • Number of events 2 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.46%
2/431 • Number of events 2 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
1.4%
6/431 • Number of events 7 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.46%
2/431 • Number of events 2 • From baseline up to 64 months
|
1.4%
3/220 • Number of events 3 • From baseline up to 64 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.46%
2/431 • Number of events 2 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Vascular disorders
HAEMATOMA
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Vascular disorders
THROMBOSIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Blood and lymphatic system disorders
MYELOSUPPRESSION
|
0.46%
2/431 • Number of events 2 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Cardiac disorders
VENTRICULAR ARRHYTHMIA
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/217 • From baseline up to 64 months
|
|
Gastrointestinal disorders
AUTOIMMUNE PANCREATITIS
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Infections and infestations
SEPTIC SHOCK
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Injury, poisoning and procedural complications
FALL
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Nervous system disorders
SYNCOPE
|
0.23%
1/431 • Number of events 1 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Psychiatric disorders
HYPOMANIA
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
|
Vascular disorders
EMBOLISM VENOUS
|
0.00%
0/431 • From baseline up to 64 months
|
0.45%
1/220 • Number of events 1 • From baseline up to 64 months
|
Other adverse events
| Measure |
Atezolizumab + Paclitaxel
n=431 participants at risk
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
Placebo + Paclitaxel
n=220 participants at risk
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
29.7%
128/431 • Number of events 277 • From baseline up to 64 months
|
30.0%
66/220 • Number of events 134 • From baseline up to 64 months
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
13.0%
56/431 • Number of events 181 • From baseline up to 64 months
|
9.1%
20/220 • Number of events 44 • From baseline up to 64 months
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
22.7%
98/431 • Number of events 253 • From baseline up to 64 months
|
21.8%
48/220 • Number of events 103 • From baseline up to 64 months
|
|
Endocrine disorders
HYPERTHYROIDISM
|
5.8%
25/431 • Number of events 28 • From baseline up to 64 months
|
0.00%
0/220 • From baseline up to 64 months
|
|
Endocrine disorders
HYPOTHYROIDISM
|
11.4%
49/431 • Number of events 65 • From baseline up to 64 months
|
2.7%
6/220 • Number of events 6 • From baseline up to 64 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
8.6%
37/431 • Number of events 45 • From baseline up to 64 months
|
8.6%
19/220 • Number of events 21 • From baseline up to 64 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
9.7%
42/431 • Number of events 47 • From baseline up to 64 months
|
6.8%
15/220 • Number of events 22 • From baseline up to 64 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
19.0%
82/431 • Number of events 103 • From baseline up to 64 months
|
15.0%
33/220 • Number of events 56 • From baseline up to 64 months
|
|
Gastrointestinal disorders
DIARRHOEA
|
30.2%
130/431 • Number of events 209 • From baseline up to 64 months
|
22.7%
50/220 • Number of events 88 • From baseline up to 64 months
|
|
Gastrointestinal disorders
DRY MOUTH
|
5.6%
24/431 • Number of events 32 • From baseline up to 64 months
|
3.6%
8/220 • Number of events 9 • From baseline up to 64 months
|
|
Gastrointestinal disorders
DYSPEPSIA
|
3.9%
17/431 • Number of events 18 • From baseline up to 64 months
|
5.0%
11/220 • Number of events 12 • From baseline up to 64 months
|
|
Gastrointestinal disorders
NAUSEA
|
27.1%
117/431 • Number of events 167 • From baseline up to 64 months
|
24.5%
54/220 • Number of events 108 • From baseline up to 64 months
|
|
Gastrointestinal disorders
STOMATITIS
|
5.3%
23/431 • Number of events 29 • From baseline up to 64 months
|
4.5%
10/220 • Number of events 18 • From baseline up to 64 months
|
|
Gastrointestinal disorders
VOMITING
|
16.2%
70/431 • Number of events 110 • From baseline up to 64 months
|
9.1%
20/220 • Number of events 36 • From baseline up to 64 months
|
|
General disorders
ASTHENIA
|
23.4%
101/431 • Number of events 149 • From baseline up to 64 months
|
21.4%
47/220 • Number of events 61 • From baseline up to 64 months
|
|
General disorders
FATIGUE
|
27.6%
119/431 • Number of events 154 • From baseline up to 64 months
|
25.9%
57/220 • Number of events 73 • From baseline up to 64 months
|
|
General disorders
OEDEMA PERIPHERAL
|
12.1%
52/431 • Number of events 66 • From baseline up to 64 months
|
10.0%
22/220 • Number of events 29 • From baseline up to 64 months
|
|
General disorders
PYREXIA
|
15.8%
68/431 • Number of events 92 • From baseline up to 64 months
|
11.4%
25/220 • Number of events 39 • From baseline up to 64 months
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.9%
34/431 • Number of events 41 • From baseline up to 64 months
|
7.3%
16/220 • Number of events 19 • From baseline up to 64 months
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.7%
29/431 • Number of events 45 • From baseline up to 64 months
|
8.2%
18/220 • Number of events 22 • From baseline up to 64 months
|
|
Infections and infestations
URINARY TRACT INFECTION
|
8.4%
36/431 • Number of events 48 • From baseline up to 64 months
|
5.0%
11/220 • Number of events 15 • From baseline up to 64 months
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
20.0%
86/431 • Number of events 168 • From baseline up to 64 months
|
17.3%
38/220 • Number of events 62 • From baseline up to 64 months
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
20.2%
87/431 • Number of events 165 • From baseline up to 64 months
|
17.7%
39/220 • Number of events 68 • From baseline up to 64 months
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
15.8%
68/431 • Number of events 361 • From baseline up to 64 months
|
15.9%
35/220 • Number of events 220 • From baseline up to 64 months
|
|
Investigations
WEIGHT DECREASED
|
7.4%
32/431 • Number of events 35 • From baseline up to 64 months
|
2.7%
6/220 • Number of events 6 • From baseline up to 64 months
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
15.1%
65/431 • Number of events 285 • From baseline up to 64 months
|
13.6%
30/220 • Number of events 203 • From baseline up to 64 months
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
15.3%
66/431 • Number of events 106 • From baseline up to 64 months
|
10.0%
22/220 • Number of events 33 • From baseline up to 64 months
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
16.0%
69/431 • Number of events 96 • From baseline up to 64 months
|
9.5%
21/220 • Number of events 25 • From baseline up to 64 months
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
9.3%
40/431 • Number of events 51 • From baseline up to 64 months
|
9.1%
20/220 • Number of events 23 • From baseline up to 64 months
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
11.1%
48/431 • Number of events 59 • From baseline up to 64 months
|
11.4%
25/220 • Number of events 34 • From baseline up to 64 months
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
11.1%
48/431 • Number of events 61 • From baseline up to 64 months
|
10.5%
23/220 • Number of events 34 • From baseline up to 64 months
|
|
Nervous system disorders
DIZZINESS
|
8.8%
38/431 • Number of events 43 • From baseline up to 64 months
|
9.1%
20/220 • Number of events 23 • From baseline up to 64 months
|
|
Nervous system disorders
DYSGEUSIA
|
8.4%
36/431 • Number of events 39 • From baseline up to 64 months
|
7.3%
16/220 • Number of events 19 • From baseline up to 64 months
|
|
Nervous system disorders
HEADACHE
|
13.7%
59/431 • Number of events 76 • From baseline up to 64 months
|
17.3%
38/220 • Number of events 44 • From baseline up to 64 months
|
|
Nervous system disorders
HYPOAESTHESIA
|
6.0%
26/431 • Number of events 37 • From baseline up to 64 months
|
7.3%
16/220 • Number of events 20 • From baseline up to 64 months
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
29.2%
126/431 • Number of events 173 • From baseline up to 64 months
|
27.3%
60/220 • Number of events 83 • From baseline up to 64 months
|
|
Nervous system disorders
PARAESTHESIA
|
9.3%
40/431 • Number of events 52 • From baseline up to 64 months
|
10.0%
22/220 • Number of events 30 • From baseline up to 64 months
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
10.2%
44/431 • Number of events 52 • From baseline up to 64 months
|
10.5%
23/220 • Number of events 26 • From baseline up to 64 months
|
|
Psychiatric disorders
INSOMNIA
|
7.7%
33/431 • Number of events 40 • From baseline up to 64 months
|
10.0%
22/220 • Number of events 22 • From baseline up to 64 months
|
|
Reproductive system and breast disorders
BREAST PAIN
|
6.5%
28/431 • Number of events 34 • From baseline up to 64 months
|
4.1%
9/220 • Number of events 10 • From baseline up to 64 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
20.0%
86/431 • Number of events 109 • From baseline up to 64 months
|
16.8%
37/220 • Number of events 44 • From baseline up to 64 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
11.4%
49/431 • Number of events 57 • From baseline up to 64 months
|
10.9%
24/220 • Number of events 29 • From baseline up to 64 months
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
6.0%
26/431 • Number of events 30 • From baseline up to 64 months
|
6.8%
15/220 • Number of events 18 • From baseline up to 64 months
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
58.7%
253/431 • Number of events 257 • From baseline up to 64 months
|
53.6%
118/220 • Number of events 124 • From baseline up to 64 months
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
5.8%
25/431 • Number of events 29 • From baseline up to 64 months
|
3.6%
8/220 • Number of events 8 • From baseline up to 64 months
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
10.9%
47/431 • Number of events 74 • From baseline up to 64 months
|
8.6%
19/220 • Number of events 22 • From baseline up to 64 months
|
|
Skin and subcutaneous tissue disorders
RASH
|
18.1%
78/431 • Number of events 108 • From baseline up to 64 months
|
16.4%
36/220 • Number of events 51 • From baseline up to 64 months
|
|
Vascular disorders
HOT FLUSH
|
4.4%
19/431 • Number of events 21 • From baseline up to 64 months
|
5.0%
11/220 • Number of events 12 • From baseline up to 64 months
|
|
Vascular disorders
HYPERTENSION
|
4.6%
20/431 • Number of events 35 • From baseline up to 64 months
|
5.5%
12/220 • Number of events 13 • From baseline up to 64 months
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
5.1%
22/431 • Number of events 41 • From baseline up to 64 months
|
4.1%
9/220 • Number of events 21 • From baseline up to 64 months
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
5.1%
22/431 • Number of events 32 • From baseline up to 64 months
|
2.7%
6/220 • Number of events 16 • From baseline up to 64 months
|
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