Trial Outcomes & Findings for A Study of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus (+) Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Follicular Lymphoma (FL) or Rituximab + CHOP in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (NCT NCT02596971)
NCT ID: NCT02596971
Last Updated: 2021-05-24
Results Overview
Primary end point was positron emission tomography (PET) CR at EOI by IRC according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to \[\</=\] mediastinum), or 3 (uptake less than \[\<\] mediastinum but \</=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites; no new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. All PET evaluable 1L FL and 1L DLBCL participants with at least one dose of atezolizumab were included in efficacy population.
COMPLETED
PHASE1/PHASE2
91 participants
Up to approximately 6 months
2021-05-24
Participant Flow
The study was conducted at 15 sites in 3 countries (Italy, Australia, and USA).
Out of the 117 subjects who were screened for this study, 91 subjects were enrolled to either FL treatment cohort (Atezo-G-Benda, Atezo-G-CHOP) or DLBCL cohort (Atezo-R-CHOP) and 26 subjects failed screening.
Participant milestones
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-G-CHOP Cohort (Safety Run-In Phase)
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
7
|
42
|
|
Overall Study
COMPLETED
|
32
|
5
|
33
|
|
Overall Study
NOT COMPLETED
|
10
|
2
|
9
|
Reasons for withdrawal
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-G-CHOP Cohort (Safety Run-In Phase)
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Overall Study
Death
|
5
|
1
|
5
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
4
|
Baseline Characteristics
A Study of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus (+) Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Follicular Lymphoma (FL) or Rituximab + CHOP in Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Baseline characteristics by cohort
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
n=42 Participants
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-G-CHOP Cohort (Safety Run-In Phase)
n=7 Participants
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
n=42 Participants
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
Total
n=91 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
59.2 years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 6 monthsPopulation: Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of relapsed/refractory \[r/r\] FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab).
Primary end point was positron emission tomography (PET) CR at EOI by IRC according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to \[\</=\] mediastinum), or 3 (uptake less than \[\<\] mediastinum but \</=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites; no new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. All PET evaluable 1L FL and 1L DLBCL participants with at least one dose of atezolizumab were included in efficacy population.
Outcome measures
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
n=40 Participants
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-R-CHOP Cohort (Expansion Phase)
n=40 Participants
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Percentage of Participants With Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria
|
75 percentage of participants
Interval 61.29 to 85.76
|
77.5 percentage of participants
Interval 64.02 to 87.73
|
—
|
PRIMARY outcome
Timeframe: Baseline up to approximately 4 yearsPopulation: The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
n=42 Participants
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-R-CHOP Cohort (Expansion Phase)
n=7 Participants
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
n=42 Participants
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 6 monthsPopulation: Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab).
Tumor response assessment was performed by the investigator according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake \</=mediastinum), or 3 (uptake \<mediastinum but \</=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. 90% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.
Outcome measures
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
n=40 Participants
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-R-CHOP Cohort (Expansion Phase)
n=40 Participants
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Percentage of Participants With CR at EOI, as Determined by the Investigator Using Lugano 2014 Criteria
|
87.5 percentage of participants
Interval 75.5 to 94.94
|
77.5 percentage of participants
Interval 64.02 to 87.73
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 6 monthsPopulation: Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab).
Complete response according to the modified Cheson 2007 criteria using PET/CT scan: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. Partial Response (PR): at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.
Outcome measures
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
n=40 Participants
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-R-CHOP Cohort (Expansion Phase)
n=40 Participants
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Percentage of Participants With CR at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria
|
75.0 percentage of participants
Interval 61.29 to 85.76
|
77.5 percentage of participants
Interval 64.02 to 87.73
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 6 monthsPopulation: Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab).
Complete response according to modified Cheson 2007 criteria using PET/CT scan: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy.
Outcome measures
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
n=40 Participants
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-R-CHOP Cohort (Expansion Phase)
n=40 Participants
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Percentage of Participants With CR at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria
|
80.0 percentage of participants
Interval 66.8 to 89.64
|
75.0 percentage of participants
Interval 61.29 to 85.76
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 6 monthsPopulation: Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab).
Objective response: having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.
Outcome measures
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
n=40 Participants
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-R-CHOP Cohort (Expansion Phase)
n=40 Participants
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria
|
90.0 percentage of participants
Interval 78.56 to 96.51
|
90.0 percentage of participants
Interval 78.56 to 96.51
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 6 monthsPopulation: Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab).
Objective response: having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.
Outcome measures
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
n=40 Participants
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-R-CHOP Cohort (Expansion Phase)
n=40 Participants
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria
|
95.0 percentage of participants
Interval 85.08 to 99.1
|
87.5 percentage of participants
Interval 75.5 to 94.94
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 6 monthsPopulation: Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab).
Tumor response assessment was performed by IRC according to modified Lugano classification using PET/CT scan. OR defined as a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake \</=mediastinum), or 3 (uptake \<mediastinum but \</=liver) with/without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR: a score 4 (uptake moderately greater than \[\>\] liver) or 5 (uptake markedly \>liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.
Outcome measures
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
n=40 Participants
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-R-CHOP Cohort (Expansion Phase)
n=40 Participants
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Lugano 2014 Criteria
|
90.0 percentage of participants
Interval 78.56 to 96.51
|
87.5 percentage of participants
Interval 75.5 to 94.94
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 6 monthsPopulation: Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab).
Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT scan. OR: a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake \</=mediastinum), or 3 (uptake \<mediastinum but \</=liver) with or without a residual mass on PET 5-PS, for lymph nodes \& extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR with a score 4 (uptake moderately greater than \[\>\] liver) or 5 (uptake markedly \>liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.
Outcome measures
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
n=40 Participants
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-R-CHOP Cohort (Expansion Phase)
n=40 Participants
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Lugano 2014 Criteria
|
95.0 percentage of participants
Interval 85.08 to 99.1
|
87.5 percentage of participants
Interval 75.5 to 94.94
|
—
|
SECONDARY outcome
Timeframe: Baseline up to approximately 4 years (assessed at Baseline, 6 to 8 weeks after Day [D] 1 of Cycle [Cy] 6 or 8 (1Cy: 21 or 28 days), then every 2 months up to 24 months, at 35 days of last dose, and at every 3 months post-treatment follow-up [up 4 years])Population: All PET evaluable 1L FL and 1L DLBCL patients that received at least one dose of atezolizumab.
CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy.
Outcome measures
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
n=40 Participants
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-R-CHOP Cohort (Expansion Phase)
n=40 Participants
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Percentage of Participants With Best Response of CR or PR During Study, as Determined by Investigator Using Modified Cheson 2007 Criteria
|
80.0 percentage of participants
Interval 66.8 to 89.64
|
75.0 percentage of participants
Interval 61.29 to 85.76
|
—
|
SECONDARY outcome
Timeframe: Induction: Predose, 0.5 hour (h) postinfusion on Day (D) 1 of Cy1,2,5,6 (1Cy: 21/28 days); Maintenance: Predose, 0.5h postinfusion on Day 1 of Month 1,3,7,15,23; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years)Population: All participants who received at least 1 dose of study treatment and who provided at least one pharmacokinetic (PK) sample.
Predose time point was "any time prior to dose" for Cycle (Cy) 1 and "within 5 hour prior to dose" for other cycles (Cy 2,5,6) and for Months 1 to 24 during maintenance phase. Infusion duration for administration of first infusion should begin at an initial rate of 50 milligrams per hour (mg/hour). If no reaction occurs, increase the infusion rate in 100 mg/hour increments every 30 minutes to a maximum of 400 mg/hour.
Outcome measures
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
n=42 Participants
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-R-CHOP Cohort (Expansion Phase)
n=7 Participants
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Observed Serum Obinutuzumab Concentration
C1 Cmax after 1st infusion
|
329 ug/mL
Interval 21.7 to 513.0
|
400 ug/mL
Interval 284.0 to 450.0
|
—
|
|
Observed Serum Obinutuzumab Concentration
C1 Cmin after the last infusion on C1
|
322 ug/mL
Interval 168.0 to 486.0
|
399 ug/mL
Interval 236.0 to 611.0
|
—
|
|
Observed Serum Obinutuzumab Concentration
C6 - Cmax after last dosing of induction
|
544 ug/mL
Interval 387.0 to 883.0
|
659 ug/mL
Interval 287.0 to 838.0
|
—
|
|
Observed Serum Obinutuzumab Concentration
C6 - Cmin after last dosing of induction
|
203 ug/mL
Interval 137.0 to 471.0
|
245 ug/mL
Interval 171.0 to 481.0
|
—
|
SECONDARY outcome
Timeframe: Atezo-R-CHOP: Predose on D1 of Cy2,3,5,8,9,10,11,12,16,20,25 (1Cy:21 days), 0.5h postinfusion of D1 of Cy2,9; at 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years)Population: All participants who received at least 1 dose of study treatment and who provided at least one pharmacokinetic (PK) sample. 0 represents no data was collected at that cycle.
Atezo-G-Benda: Induction:Predose on D1 of Cy5,6 \& D1,15 of Cy2,3 (1Cy:21/28 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days \& 1 year of last dose or at treatment discontinuation (up to 4 years); Atezo-G-CHOP: Induction:Predose on D1 of Cy2,3,5,6 (1Cy:21 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,3,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days \& 1 year of last dose or at treatment discontinuation (up to 4 years). Predose time point was "within 5 hour prior to dose" for Cy2,3,5,6 during induction phase and for Months 1 to 24 during maintenance phase. infusion length: 30-60 minutes.
Outcome measures
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
n=42 Participants
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-R-CHOP Cohort (Expansion Phase)
n=42 Participants
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
n=7 Participants
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Observed Serum Atezolizumab Concentration
Cycle 2 - Cmax after 1st infusion
|
275 ug/mL
Interval 193.0 to 388.0
|
332 ug/mL
Interval 227.0 to 472.0
|
424 ug/mL
Interval 340.0 to 670.0
|
|
Observed Serum Atezolizumab Concentration
C2 - Cmin before 2nd infusion
|
83 ug/mL
Interval 59.0 to 128.0
|
82.1 ug/mL
Interval 55.7 to 122.0
|
94 ug/mL
Interval 65.0 to 139.0
|
|
Observed Serum Atezolizumab Concentration
C6 - Cmin after 6th infusion
|
256 ug/mL
Interval 93.0 to 369.0
|
—
|
195 ug/mL
Interval 157.0 to 296.0
|
|
Observed Serum Atezolizumab Concentration
C8 - Cmax after 7th infusion
|
—
|
486.5 ug/mL
Interval 363.0 to 793.0
|
—
|
|
Observed Serum Atezolizumab Concentration
C8 - Cmin before 8th infusion
|
—
|
184 ug/mL
Interval 104.0 to 359.0
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5h postinfusion on D1 of Cy1,2,5,8 (1Cy: 21 days); at 120 days and 1 year after last rituximab dose or at treatment discontinuation (up to 4 years)Population: All participants who received at least 1 dose of study treatment and who provided at least one PK sample.
Predose time point was "any time prior to dose" for Cycle 1 and "within 5 hour prior to dose" for other cycles (Cycles 2,5,8) during induction phase and for Months 1 to 24 during maintenance phase. Infusion duration for administration of first infusion should begin at an initial rate of 50 mg/hour. If no infusion-related or hypersensitivity reaction occurs, increase the infusion rate in 50 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. If no reaction occurs, increase the infusion rate in 100 mg/hour increments every 30 minutes to a maximum of 400 mg/hour.
Outcome measures
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
n=42 Participants
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-R-CHOP Cohort (Expansion Phase)
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Observed Serum Rituximab Concentration
C1 - Cmax after dosing C1
|
159 ug/mL
Interval 0.5 to 292.0
|
—
|
—
|
|
Observed Serum Rituximab Concentration
C1 - Ctrough after dosing C1
|
26.1 ug/mL
Interval 0.5 to 41.3
|
—
|
—
|
|
Observed Serum Rituximab Concentration
C8 - Cmax after dosing C8
|
229 ug/mL
Interval 185.0 to 303.0
|
—
|
—
|
|
Observed Serum Rituximab Concentration
C8 - Ctrough after dosing C8
|
105.5 ug/mL
Interval 39.9 to 150.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to approximately 4 yearsPopulation: The safety analysis population consisted of all participants who received at least one dose of study drug in the Atezo-G-Benda cohort
Induction: Predose (any time prior to dose) on D1 of Cy1,5,6 (1Cy: 21/28 days); Maintenance: Predose (any time prior to dose) on D1 of Month 1; at 120 days and 1 year of last obinutuzumab dose or at treatment discontinuation (up to 4 years)
Outcome measures
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
n=42 Participants
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-R-CHOP Cohort (Expansion Phase)
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Induction Cycle 1 Day 1
|
2.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Induction Cycle 5 Day 1
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Induction Cycle 6 Day 1
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Maintenance Month 1
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Study Drug Completion or Early Discontinuation
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Obinutuzumab Day 120 Follow up
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to approximately 4 yearsPopulation: The safety analysis population consisted of all participants who received at least one dose of study drug in the Atezo-R-CHOP cohort.
Induction: Predose (any time prior to dose) on D1 of Cy1,5,8 (1Cy: 21 days); Maintenance: at 120 days and 1 year of last rituximab dose or at treatment discontinuation (up to 4 years)
Outcome measures
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
n=42 Participants
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-R-CHOP Cohort (Expansion Phase)
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab
Study Drug Completion or Early Discontinuation
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab
Baseline
|
14.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab
Induction Cycle 1 Day 1
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab
Induction Cycle 5 Day 1
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab
Induction Cycle 8 Day 1
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab
Rituximab Day 120 Follow up
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab
Rituximab 1 Year Follow up
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to approximately 4 yearsPopulation: The analysis population consisted of all participants who received at least one dose of study drug.
Atezo-G-CHOP: Induction: Predose on D1 of Cy2,3,5,6 (1 Cy: 21 days); Maintenance: Predose on D1 of Month 1,2,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years); Atezo-R-CHOP: Predose on D1 of Cy 2,3,5,8,16,25 (1 Cy: 21 days); at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). Predose time point was "any time prior to dose" for Cycles 2,3,5,6,8 during induction phase, for Cycles 16,25 during consolidation treatment, and for Months 1 to 24 during maintenance phase. Atezo-G-Benda: Induction: Predose on D1 of Cy2,3,5,6 (1Cy: 28 days), Cy3D15: Predose; ; Maintenance: Predose on D1 of Month 1,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). The percentage of participants with positive results for ATAs to atezolizumab at baseline and at post-baseline time points are reported.
Outcome measures
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
n=42 Participants
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-R-CHOP Cohort (Expansion Phase)
n=7 Participants
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
n=42 Participants
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Baseline
|
2.4 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Induction Cycle 2 Day 1
|
0 percentage of participants
|
0 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Consolidation Cycle 16
|
—
|
—
|
5.9 percentage of participants
|
|
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Atezolizumab Day 120 Follow up
|
0 percentage of participants
|
0 percentage of participants
|
9.1 percentage of participants
|
|
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Atezo PK and Immunogenicity Follow Up (1YR)
|
0 percentage of participants
|
0 percentage of participants
|
5.6 percentage of participants
|
Adverse Events
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
Atezo-G-CHOP Cohort (Safety Run-In Phase)
Atezo-R-CHOP Cohort (Expansion Phase)
Serious adverse events
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
n=42 participants at risk
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-G-CHOP Cohort (Safety Run-In Phase)
n=7 participants at risk
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
n=42 participants at risk
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
AUTOIMMUNE HAEMOLYTIC ANAEMIA
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
9.5%
4/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
6/42 • Number of events 7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Cardiac disorders
ATRIAL TACHYCARDIA
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Cardiac disorders
CARDIAC ARREST
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Cardiac disorders
MYOCARDITIS
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Ear and labyrinth disorders
HYPOACUSIS
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Eye disorders
DIPLOPIA
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
IMMUNE-MEDIATED ENTEROCOLITIS
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
NAUSEA
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
PANCREATITIS
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
General disorders
PYREXIA
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
General disorders
SUDDEN DEATH
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
EPSTEIN-BARR VIRUS INFECTION
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
GASTROENTERITIS SALMONELLA
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
KIDNEY INFECTION
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
PNEUMONIA
|
11.9%
5/42 • Number of events 5 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
PNEUMONIA INFLUENZAL
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
PNEUMONIA VIRAL
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
SKIN INFECTION
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
URINARY TRACT INFECTION STAPHYLOCOCCAL
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Nervous system disorders
MIGRAINE
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Nervous system disorders
SYNCOPE
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL INFLAMMATION
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
OBLITERATIVE BRONCHIOLITIS
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
Other adverse events
| Measure |
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
n=42 participants at risk
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month \[q2m\]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase.
|
Atezo-G-CHOP Cohort (Safety Run-In Phase)
n=7 participants at risk
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment.
|
Atezo-R-CHOP Cohort (Expansion Phase)
n=42 participants at risk
Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
9.5%
4/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
6/42 • Number of events 8 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Blood and lymphatic system disorders
LYMPH NODE PAIN
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
33.3%
14/42 • Number of events 22 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
42.9%
3/7 • Number of events 6 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
52.4%
22/42 • Number of events 31 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
9.5%
4/42 • Number of events 6 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Cardiac disorders
PALPITATIONS
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
28.6%
2/7 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Endocrine disorders
HYPOPHYSITIS
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Eye disorders
DRY EYE
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
28.6%
2/7 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Eye disorders
OCULAR HYPERAEMIA
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Eye disorders
PHOTOPHOBIA
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Eye disorders
VISION BLURRED
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
9.5%
4/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
19.0%
8/42 • Number of events 10 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
28.6%
2/7 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
11.9%
5/42 • Number of events 5 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
14.3%
6/42 • Number of events 7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
9.5%
4/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
COLITIS
|
9.5%
4/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
CONSTIPATION
|
42.9%
18/42 • Number of events 27 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
42.9%
3/7 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
42.9%
18/42 • Number of events 26 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
DEFAECATION URGENCY
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
DIARRHOEA
|
47.6%
20/42 • Number of events 47 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
42.9%
3/7 • Number of events 10 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
33.3%
14/42 • Number of events 23 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
DRY MOUTH
|
11.9%
5/42 • Number of events 5 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
9.5%
4/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
DUODENAL ULCER HAEMORRHAGE
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
19.0%
8/42 • Number of events 11 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
4.8%
2/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
FLATULENCE
|
7.1%
3/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
GLOSSITIS
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
NAUSEA
|
52.4%
22/42 • Number of events 42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
71.4%
5/7 • Number of events 8 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
31.0%
13/42 • Number of events 22 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
RECTAL DISCHARGE
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
STEATORRHOEA
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
STOMATITIS
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
7.1%
3/42 • Number of events 5 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
VOMITING
|
26.2%
11/42 • Number of events 15 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
28.6%
2/7 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
21.4%
9/42 • Number of events 11 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
General disorders
ASTHENIA
|
7.1%
3/42 • Number of events 5 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
4.8%
2/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
General disorders
CHEST DISCOMFORT
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
General disorders
CHEST PAIN
|
23.8%
10/42 • Number of events 10 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
9.5%
4/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
General disorders
CHILLS
|
7.1%
3/42 • Number of events 5 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
General disorders
FATIGUE
|
54.8%
23/42 • Number of events 27 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
71.4%
5/7 • Number of events 6 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
40.5%
17/42 • Number of events 22 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
General disorders
FEELING COLD
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
16.7%
7/42 • Number of events 9 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
General disorders
MUCOSAL INFLAMMATION
|
2.4%
1/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
28.6%
2/7 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
7.1%
3/42 • Number of events 5 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
General disorders
OEDEMA PERIPHERAL
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
7.1%
3/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
General disorders
PAIN
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
General disorders
PERIPHERAL SWELLING
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
General disorders
PYREXIA
|
23.8%
10/42 • Number of events 12 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
11.9%
5/42 • Number of events 9 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Immune system disorders
SEASONAL ALLERGY
|
7.1%
3/42 • Number of events 5 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
BRONCHITIS
|
9.5%
4/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
CONJUNCTIVITIS
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
28.6%
2/7 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
HERPES ZOSTER
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
28.6%
2/7 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
NASOPHARYNGITIS
|
11.9%
5/42 • Number of events 8 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
PNEUMONIA
|
9.5%
4/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
SINUSITIS
|
16.7%
7/42 • Number of events 7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
11.9%
5/42 • Number of events 5 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
SKIN INFECTION
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
28.6%
12/42 • Number of events 22 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
16.7%
7/42 • Number of events 7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
14.3%
6/42 • Number of events 8 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
FALL
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
7.1%
3/42 • Number of events 5 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
69.0%
29/42 • Number of events 45 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
28.6%
2/7 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
38.1%
16/42 • Number of events 16 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
MENISCUS INJURY
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
28.6%
2/7 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMATURIA
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
4.8%
2/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Investigations
AMYLASE INCREASED
|
9.5%
4/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Investigations
LIPASE INCREASED
|
31.0%
13/42 • Number of events 14 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
9.5%
4/42 • Number of events 6 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Investigations
WEIGHT DECREASED
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
14.3%
6/42 • Number of events 6 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
28.6%
2/7 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
4.8%
2/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
28.6%
2/7 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
19.0%
8/42 • Number of events 10 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
28.6%
2/7 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
21.4%
9/42 • Number of events 12 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
23.8%
10/42 • Number of events 10 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
57.1%
4/7 • Number of events 6 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
19.0%
8/42 • Number of events 13 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
9.5%
4/42 • Number of events 6 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
9.5%
4/42 • Number of events 5 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
7.1%
3/42 • Number of events 6 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
11.9%
5/42 • Number of events 7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
28.6%
2/7 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
4.8%
2/42 • Number of events 5 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
9.5%
4/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
9.5%
4/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
4.8%
2/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
11.9%
5/42 • Number of events 5 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
9.5%
4/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
19.0%
8/42 • Number of events 10 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACROCHORDON
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN EPITHELIAL CANCER
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Nervous system disorders
AMNESIA
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Nervous system disorders
BALANCE DISORDER
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Nervous system disorders
DIZZINESS
|
16.7%
7/42 • Number of events 12 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
9.5%
4/42 • Number of events 6 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
6/42 • Number of events 6 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Nervous system disorders
HEADACHE
|
45.2%
19/42 • Number of events 25 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
19.0%
8/42 • Number of events 13 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Nervous system disorders
HYPOAESTHESIA
|
9.5%
4/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
28.6%
2/7 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Nervous system disorders
PARAESTHESIA
|
7.1%
3/42 • Number of events 5 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
28.6%
2/7 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
31.0%
13/42 • Number of events 15 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Nervous system disorders
TASTE DISORDER
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Product Issues
DEVICE OCCLUSION
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Psychiatric disorders
ANXIETY
|
16.7%
7/42 • Number of events 7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
7.1%
3/42 • Number of events 6 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Psychiatric disorders
INSOMNIA
|
16.7%
7/42 • Number of events 7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
28.6%
2/7 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
16.7%
7/42 • Number of events 8 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Psychiatric disorders
MANIA
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Renal and urinary disorders
DYSURIA
|
2.4%
1/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Renal and urinary disorders
MICTURITION URGENCY
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Reproductive system and breast disorders
VAGINAL DISCHARGE
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Reproductive system and breast disorders
VULVOVAGINAL PAIN
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
59.5%
25/42 • Number of events 31 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
71.4%
5/7 • Number of events 9 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
28.6%
12/42 • Number of events 18 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
16.7%
7/42 • Number of events 8 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
7.1%
3/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
19.0%
8/42 • Number of events 8 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
19.0%
8/42 • Number of events 11 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
9.5%
4/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL DISORDER
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
9.5%
4/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
28.6%
2/7 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
11.9%
5/42 • Number of events 6 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
7.1%
3/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
7.1%
3/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
28.6%
2/7 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
23.8%
10/42 • Number of events 10 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
4.8%
2/42 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 2 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
9.5%
4/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
9.5%
4/42 • Number of events 5 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
9.5%
4/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
7.1%
3/42 • Number of events 3 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
28.6%
12/42 • Number of events 14 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
9.5%
4/42 • Number of events 4 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
RASH
|
33.3%
14/42 • Number of events 22 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
9.5%
4/42 • Number of events 6 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
9.5%
4/42 • Number of events 5 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
RASH VESICULAR
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Vascular disorders
HYPERTENSION
|
14.3%
6/42 • Number of events 9 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/7 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
2.4%
1/42 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
|
Vascular disorders
PERIPHERAL COLDNESS
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
0.00%
0/42 • Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
|
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