Trial Outcomes & Findings for Check Point Inhibition After Autologous Stem Cell Transplantation in Patients at High Risk of Post Transplant Recurrence (NCT NCT02681302)
NCT ID: NCT02681302
Last Updated: 2025-07-25
Results Overview
To assess the safety of combined check point inhibition with nivolumab and ipilimumab after autologous hematopoietic stem cell transplantation in patients at high risk for post-transplant recurrence including patients with persistent and recurrent high risk diffuse large B cell lymphoma, high risk and recurrent T cell lymphoma and high risk and recurrent multiple myeloma. The composite endpoint consisting of the occurrence of at least one treatment-related limiting toxicity (after combined checkpoint inhibitor treatment is initiated) defined as a ≥ grade 4 non-hematologic toxicity as specified by the CTCAE. If 3 of 7 patients in a single group experience a treatment-related limiting toxicity, that single group will be terminated.
TERMINATED
PHASE1/PHASE2
46 participants
26 weeks
2025-07-25
Participant Flow
Participant milestones
| Measure |
Group A
De novo diffuse large B cell lymphoma that fails to achieve a PET negative complete response to primary rituximab and anthracycline based multi-agent chemotherapy and at least maintains stable disease after salvage chemotherapy or present double/triple hit features defined by overexpression by standard immunohistochemistry of c-MYC plus BCL2 and/or BCL6 or presence of chromosomal translocations as detected by break-apart FISH involving IGH/MYC plus IGH/BCL2 and/or IGH/BCL6 and who only received standard chemoimmunotherapy with rituximab, cyclophosphamide, vincristine and prednisone (R-CHOP) for induction and present at least stable disease after consolidation or salvage chemotherapy. Stable disease (SD) for lymphoma is defined in Appendix B: Lugano Classification for Response Assessment of Non-Hodgkin Lymphoma.
|
Group B
Recurrent high-risk diffuse large B cell lymphoma defined as relapsing within one year of completion of rituximab and anthracycline based multi-agent chemotherapy or a sAAIPI (second-line age-adjusted International Prognostic Index) intermediate or high at relapse or acquisition of double/triple hit features upon relapse (as defined in group A) and at least stable disease after salvage chemotherapy. Patients with an initial diagnosis of low-grade/indolent non-Hodgkin lymphoma (i.e. follicular, marginal zone) who present relapse with histologic transformation to diffuse large B cell lymphoma (confirmed by biopsy) and meet the definition for high-risk as presented above, are also eligible.
|
Group C
De novo high-risk T cell lymphoma with at least stable disease after primary therapy. High risk T cell lymphoma is defined as Stage III or IV disease at presentation and/or failure to achieve CR after frontline chemotherapy. Patients with ALK-positive ALCL will be excluded from the trial. Patients with ALK-negative ALCL in complete response will be excluded from the trial.
|
Group D
Recurrent T cell lymphoma with at least stable disease after salvage therapy. Patients with ALK-positive ALCL will be excluded from the trial.
|
Group E
Transplant-naïve high risk multiple myeloma with at least stable disease after most recent line of therapy. High risk myeloma is defined as those carrying 1q amplifications, 1p deletions, 13q deletions by conventional cytogenetics, p53 deletions, high-risk GEP 70 scores, t(4;14), t(14;16) and t(14;20), hypodiploidy. This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.
|
Group F
Recurrent myeloma within 3 years after a single or tandem autologous transplant and at least stable disease after salvage therapy. Stable disease for multiple myeloma is defined in Appendix C: International Myeloma Working Group (IMWG). This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
8
|
4
|
8
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
4
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
2
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Group A
De novo diffuse large B cell lymphoma that fails to achieve a PET negative complete response to primary rituximab and anthracycline based multi-agent chemotherapy and at least maintains stable disease after salvage chemotherapy or present double/triple hit features defined by overexpression by standard immunohistochemistry of c-MYC plus BCL2 and/or BCL6 or presence of chromosomal translocations as detected by break-apart FISH involving IGH/MYC plus IGH/BCL2 and/or IGH/BCL6 and who only received standard chemoimmunotherapy with rituximab, cyclophosphamide, vincristine and prednisone (R-CHOP) for induction and present at least stable disease after consolidation or salvage chemotherapy. Stable disease (SD) for lymphoma is defined in Appendix B: Lugano Classification for Response Assessment of Non-Hodgkin Lymphoma.
|
Group B
Recurrent high-risk diffuse large B cell lymphoma defined as relapsing within one year of completion of rituximab and anthracycline based multi-agent chemotherapy or a sAAIPI (second-line age-adjusted International Prognostic Index) intermediate or high at relapse or acquisition of double/triple hit features upon relapse (as defined in group A) and at least stable disease after salvage chemotherapy. Patients with an initial diagnosis of low-grade/indolent non-Hodgkin lymphoma (i.e. follicular, marginal zone) who present relapse with histologic transformation to diffuse large B cell lymphoma (confirmed by biopsy) and meet the definition for high-risk as presented above, are also eligible.
|
Group C
De novo high-risk T cell lymphoma with at least stable disease after primary therapy. High risk T cell lymphoma is defined as Stage III or IV disease at presentation and/or failure to achieve CR after frontline chemotherapy. Patients with ALK-positive ALCL will be excluded from the trial. Patients with ALK-negative ALCL in complete response will be excluded from the trial.
|
Group D
Recurrent T cell lymphoma with at least stable disease after salvage therapy. Patients with ALK-positive ALCL will be excluded from the trial.
|
Group E
Transplant-naïve high risk multiple myeloma with at least stable disease after most recent line of therapy. High risk myeloma is defined as those carrying 1q amplifications, 1p deletions, 13q deletions by conventional cytogenetics, p53 deletions, high-risk GEP 70 scores, t(4;14), t(14;16) and t(14;20), hypodiploidy. This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.
|
Group F
Recurrent myeloma within 3 years after a single or tandem autologous transplant and at least stable disease after salvage therapy. Stable disease for multiple myeloma is defined in Appendix C: International Myeloma Working Group (IMWG). This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Screen Failure
|
2
|
4
|
2
|
0
|
1
|
1
|
|
Overall Study
Discontinued Due to Updated FDA Risks
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Check Point Inhibition After Autologous Stem Cell Transplantation in Patients at High Risk of Post Transplant Recurrence
Baseline characteristics by cohort
| Measure |
Group A
n=9 Participants
De novo diffuse large B cell lymphoma that fails to achieve a PET negative complete response to primary rituximab and anthracycline based multi-agent chemotherapy and at least maintains stable disease after salvage chemotherapy or present double/triple hit features defined by overexpression by standard immunohistochemistry of c-MYC plus BCL2 and/or BCL6 or presence of chromosomal translocations as detected by break-apart FISH involving IGH/MYC plus IGH/BCL2 and/or IGH/BCL6 and who only received standard chemoimmunotherapy with rituximab, cyclophosphamide, vincristine and prednisone (R-CHOP) for induction and present at least stable disease after consolidation or salvage chemotherapy. Stable disease (SD) for lymphoma is defined in Appendix B: Lugano Classification for Response Assessment of Non-Hodgkin Lymphoma.
|
Group B
n=11 Participants
Recurrent high-risk diffuse large B cell lymphoma defined as relapsing within one year of completion of rituximab and anthracycline based multi-agent chemotherapy or a sAAIPI (second-line age-adjusted International Prognostic Index) intermediate or high at relapse or acquisition of double/triple hit features upon relapse (as defined in group A) and at least stable disease after salvage chemotherapy. Patients with an initial diagnosis of low-grade/indolent non-Hodgkin lymphoma (i.e. follicular, marginal zone) who present relapse with histologic transformation to diffuse large B cell lymphoma (confirmed by biopsy) and meet the definition for high-risk as presented above, are also eligible.
|
Group C
n=8 Participants
De novo high-risk T cell lymphoma with at least stable disease after primary therapy. High risk T cell lymphoma is defined as Stage III or IV disease at presentation and/or failure to achieve CR after frontline chemotherapy. Patients with ALK-positive ALCL will be excluded from the trial. Patients with ALK-negative ALCL in complete response will be excluded from the trial.
|
Group D
n=4 Participants
Recurrent T cell lymphoma with at least stable disease after salvage therapy. Patients with ALK-positive ALCL will be excluded from the trial.
|
Group E
n=8 Participants
Transplant-naïve high risk multiple myeloma with at least stable disease after most recent line of therapy. High risk myeloma is defined as those carrying 1q amplifications, 1p deletions, 13q deletions by conventional cytogenetics, p53 deletions, high-risk GEP 70 scores, t(4;14), t(14;16) and t(14;20), hypodiploidy. This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.
|
Group F
n=6 Participants
Recurrent myeloma within 3 years after a single or tandem autologous transplant and at least stable disease after salvage therapy. Stable disease for multiple myeloma is defined in Appendix C: International Myeloma Working Group (IMWG). This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.
|
Total
n=46 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
Age, Continuous
|
51 Years
n=5 Participants
|
66 Years
n=7 Participants
|
57 Years
n=5 Participants
|
52 Years
n=4 Participants
|
69.5 Years
n=21 Participants
|
50.5 Years
n=8 Participants
|
62 Years
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
35 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
34 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
8 participants
n=5 Participants
|
4 participants
n=4 Participants
|
8 participants
n=21 Participants
|
6 participants
n=8 Participants
|
46 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: Patients at high risk for post-transplant recurrence including patients with persistent and recurrent high risk diffuse large B cell lymphoma, high risk and recurrent T cell lymphoma and high risk and recurrent multiple myeloma treated with nivolumab and ipilimumab after autologous hematopoietic stem cell transplantation
To assess the safety of combined check point inhibition with nivolumab and ipilimumab after autologous hematopoietic stem cell transplantation in patients at high risk for post-transplant recurrence including patients with persistent and recurrent high risk diffuse large B cell lymphoma, high risk and recurrent T cell lymphoma and high risk and recurrent multiple myeloma. The composite endpoint consisting of the occurrence of at least one treatment-related limiting toxicity (after combined checkpoint inhibitor treatment is initiated) defined as a ≥ grade 4 non-hematologic toxicity as specified by the CTCAE. If 3 of 7 patients in a single group experience a treatment-related limiting toxicity, that single group will be terminated.
Outcome measures
| Measure |
Group A
n=7 Participants
De novo diffuse large B cell lymphoma that fails to achieve a PET negative complete response to primary rituximab and anthracycline based multi-agent chemotherapy and at least maintains stable disease after salvage chemotherapy or present double/triple hit features defined by overexpression by standard immunohistochemistry of c-MYC plus BCL2 and/or BCL6 or presence of chromosomal translocations as detected by break-apart FISH involving IGH/MYC plus IGH/BCL2 and/or IGH/BCL6 and who only received standard chemoimmunotherapy with rituximab, cyclophosphamide, vincristine and prednisone (R-CHOP) for induction and present at least stable disease after consolidation or salvage chemotherapy. Stable disease (SD) for lymphoma is defined in Appendix B: Lugano Classification for Response Assessment of Non-Hodgkin Lymphoma.
|
Group B
n=7 Participants
Recurrent high-risk diffuse large B cell lymphoma defined as relapsing within one year of completion of rituximab and anthracycline based multi-agent chemotherapy or a sAAIPI (second-line age-adjusted International Prognostic Index) intermediate or high at relapse or acquisition of double/triple hit features upon relapse (as defined in group A) and at least stable disease after salvage chemotherapy. Patients with an initial diagnosis of low-grade/indolent non-Hodgkin lymphoma (i.e. follicular, marginal zone) who present relapse with histologic transformation to diffuse large B cell lymphoma (confirmed by biopsy) and meet the definition for high-risk as presented above, are also eligible.
|
Group C
n=5 Participants
De novo high-risk T cell lymphoma with at least stable disease after primary therapy. High risk T cell lymphoma is defined as Stage III or IV disease at presentation and/or failure to achieve CR after frontline chemotherapy. Patients with ALK-positive ALCL will be excluded from the trial. Patients with ALK-negative ALCL in complete response will be excluded from the trial.
|
Group D
n=4 Participants
Recurrent T cell lymphoma with at least stable disease after salvage therapy. Patients with ALK-positive ALCL will be excluded from the trial.
|
Group E
n=7 Participants
Transplant-naïve high risk multiple myeloma with at least stable disease after most recent line of therapy. High risk myeloma is defined as those carrying 1q amplifications, 1p deletions, 13q deletions by conventional cytogenetics, p53 deletions, high-risk GEP 70 scores, t(4;14), t(14;16) and t(14;20), hypodiploidy. This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.
|
Group F
n=5 Participants
Recurrent myeloma within 3 years after a single or tandem autologous transplant and at least stable disease after salvage therapy. Stable disease for multiple myeloma is defined in Appendix C: International Myeloma Working Group (IMWG). This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.
|
|---|---|---|---|---|---|---|
|
Safety of Combined Check Point Inhibition Therapy Via Assessment of Adverse Events and Lab Findings
|
2 Treatment-Related Limiting Toxicity
|
0 Treatment-Related Limiting Toxicity
|
0 Treatment-Related Limiting Toxicity
|
2 Treatment-Related Limiting Toxicity
|
1 Treatment-Related Limiting Toxicity
|
2 Treatment-Related Limiting Toxicity
|
Adverse Events
Group A
Group B
Group C
Group D
Group E
Group F
Serious adverse events
| Measure |
Group A
n=7 participants at risk
De novo diffuse large B cell lymphoma that fails to achieve a PET negative complete response to primary rituximab and anthracycline based multi-agent chemotherapy and at least maintains stable disease after salvage chemotherapy or present double/triple hit features defined by overexpression by standard immunohistochemistry of c-MYC plus BCL2 and/or BCL6 or presence of chromosomal translocations as detected by break-apart FISH involving IGH/MYC plus IGH/BCL2 and/or IGH/BCL6 and who only received standard chemoimmunotherapy with rituximab, cyclophosphamide, vincristine and prednisone (R-CHOP) for induction and present at least stable disease after consolidation or salvage chemotherapy. Stable disease (SD) for lymphoma is defined in Appendix B: Lugano Classification for Response Assessment of Non-Hodgkin Lymphoma.
|
Group B
n=7 participants at risk
Recurrent high-risk diffuse large B cell lymphoma defined as relapsing within one year of completion of rituximab and anthracycline based multi-agent chemotherapy or a sAAIPI (second-line age-adjusted International Prognostic Index) intermediate or high at relapse or acquisition of double/triple hit features upon relapse (as defined in group A) and at least stable disease after salvage chemotherapy. Patients with an initial diagnosis of low-grade/indolent non-Hodgkin lymphoma (i.e. follicular, marginal zone) who present relapse with histologic transformation to diffuse large B cell lymphoma (confirmed by biopsy) and meet the definition for high-risk as presented above, are also eligible.
|
Group C
n=5 participants at risk
De novo high-risk T cell lymphoma with at least stable disease after primary therapy. High risk T cell lymphoma is defined as Stage III or IV disease at presentation and/or failure to achieve CR after frontline chemotherapy. Patients with ALK-positive ALCL will be excluded from the trial. Patients with ALK-negative ALCL in complete response will be excluded from the trial.
|
Group D
n=4 participants at risk
Recurrent T cell lymphoma with at least stable disease after salvage therapy. Patients with ALK-positive ALCL will be excluded from the trial.
|
Group E
n=7 participants at risk
Transplant-naïve high risk multiple myeloma with at least stable disease after most recent line of therapy. High risk myeloma is defined as those carrying 1q amplifications, 1p deletions, 13q deletions by conventional cytogenetics, p53 deletions, high-risk GEP 70 scores, t(4;14), t(14;16) and t(14;20), hypodiploidy. This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.
|
Group F
n=5 participants at risk
Recurrent myeloma within 3 years after a single or tandem autologous transplant and at least stable disease after salvage therapy. Stable disease for multiple myeloma is defined in Appendix C: International Myeloma Working Group (IMWG). This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Adenoviremia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Endocrine disorders
Adrenal Crisis
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Alkaline Phosphatase Increased
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Bilirubin Increased
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
C-Difficile
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
CPK Increased
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Esophagitis
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Fever
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
GGT Increased
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Cardiac disorders
Heart Block
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Infection ESBL
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
L Leg Weakness
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Parainfluenza
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Progression Of Disease
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Pseudomonas Aeruginosa Sepsis
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Rigors
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
RSV Bronchiolitis
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Sepsis - Pseudomona Bacteremia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Septic Shock
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Cardiac disorders
STEMI
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Cardiac disorders
STEMI, Heart Failure
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
Other adverse events
| Measure |
Group A
n=7 participants at risk
De novo diffuse large B cell lymphoma that fails to achieve a PET negative complete response to primary rituximab and anthracycline based multi-agent chemotherapy and at least maintains stable disease after salvage chemotherapy or present double/triple hit features defined by overexpression by standard immunohistochemistry of c-MYC plus BCL2 and/or BCL6 or presence of chromosomal translocations as detected by break-apart FISH involving IGH/MYC plus IGH/BCL2 and/or IGH/BCL6 and who only received standard chemoimmunotherapy with rituximab, cyclophosphamide, vincristine and prednisone (R-CHOP) for induction and present at least stable disease after consolidation or salvage chemotherapy. Stable disease (SD) for lymphoma is defined in Appendix B: Lugano Classification for Response Assessment of Non-Hodgkin Lymphoma.
|
Group B
n=7 participants at risk
Recurrent high-risk diffuse large B cell lymphoma defined as relapsing within one year of completion of rituximab and anthracycline based multi-agent chemotherapy or a sAAIPI (second-line age-adjusted International Prognostic Index) intermediate or high at relapse or acquisition of double/triple hit features upon relapse (as defined in group A) and at least stable disease after salvage chemotherapy. Patients with an initial diagnosis of low-grade/indolent non-Hodgkin lymphoma (i.e. follicular, marginal zone) who present relapse with histologic transformation to diffuse large B cell lymphoma (confirmed by biopsy) and meet the definition for high-risk as presented above, are also eligible.
|
Group C
n=5 participants at risk
De novo high-risk T cell lymphoma with at least stable disease after primary therapy. High risk T cell lymphoma is defined as Stage III or IV disease at presentation and/or failure to achieve CR after frontline chemotherapy. Patients with ALK-positive ALCL will be excluded from the trial. Patients with ALK-negative ALCL in complete response will be excluded from the trial.
|
Group D
n=4 participants at risk
Recurrent T cell lymphoma with at least stable disease after salvage therapy. Patients with ALK-positive ALCL will be excluded from the trial.
|
Group E
n=7 participants at risk
Transplant-naïve high risk multiple myeloma with at least stable disease after most recent line of therapy. High risk myeloma is defined as those carrying 1q amplifications, 1p deletions, 13q deletions by conventional cytogenetics, p53 deletions, high-risk GEP 70 scores, t(4;14), t(14;16) and t(14;20), hypodiploidy. This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.
|
Group F
n=5 participants at risk
Recurrent myeloma within 3 years after a single or tandem autologous transplant and at least stable disease after salvage therapy. Stable disease for multiple myeloma is defined in Appendix C: International Myeloma Working Group (IMWG). This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Generalised Pruritis (Neck, Face, Chest)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Generalized Weakness
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Pruritus Localised (Palm And Soles)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Generalised Pruritis
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Pruritus Torso, Arms
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Abdominal Pain
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Abdominal Pain (Right Upper Quad)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Renal and urinary disorders
Acute Kidney Failure
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Adenoviremia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Endocrine disorders
Adrenal Insufficiency
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Alanine Aminotransferase Increased
|
71.4%
5/7 • Number of events 14 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
80.0%
4/5 • Number of events 8 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 8 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Alkaline Phosphatase Increased
|
57.1%
4/7 • Number of events 6 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 13 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Altered Mental Status
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Amylase Increased
|
57.1%
4/7 • Number of events 16 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
50.0%
2/4 • Number of events 9 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 6 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
7/7 • Number of events 18 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
85.7%
6/7 • Number of events 69 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
80.0%
4/5 • Number of events 10 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
75.0%
3/4 • Number of events 6 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
71.4%
5/7 • Number of events 31 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
80.0%
4/5 • Number of events 52 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Blood and lymphatic system disorders
Anemia (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
42.9%
3/7 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
50.0%
2/4 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
42.9%
3/7 • Number of events 5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Aspartate Aminotransferase Increased
|
71.4%
5/7 • Number of events 13 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 9 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
B/L Axillary Swelling
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Benign Lung Tissue (Bronchoscopy Result)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Bilirubin Increased
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 9 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Eye disorders
Blepharitis
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Bloating
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Eye disorders
Blurry Vision
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Eye disorders
Blurry Vision (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Brachial Plexopathy
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Bump/ Mass L Occiput
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Injury, poisoning and procedural complications
Burn Right Wrist
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Burning Of Back
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Eye disorders
Burning/Itching Eyes
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Eye disorders
Cataract
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
C-Difficile
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Chest Pain
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Chest Tightness
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Chest Tightness (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Chills
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Cough
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Colitis
|
28.6%
2/7 • Number of events 7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Psychiatric disorders
Confusion
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Nodules
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Constipation (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Coronavirus
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Endocrine disorders
Cortisol Decreased
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
57.1%
4/7 • Number of events 9 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
57.1%
4/7 • Number of events 4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough (Intermittent)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough Sequelae Of RSV
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough, Dry
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
CPK Increased
|
14.3%
1/7 • Number of events 5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Cramping Hands, Legs (Intermittent)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Cramps
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Creatinine Increased
|
42.9%
3/7 • Number of events 7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 8 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
42.9%
3/7 • Number of events 4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Dehydration
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
7/7 • Number of events 17 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
71.4%
5/7 • Number of events 13 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
60.0%
3/5 • Number of events 11 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
50.0%
2/4 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
57.1%
4/7 • Number of events 16 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 8 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Diarrhea (Intermittent)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Disease Progression
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Diverticulitis
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Dizziness (Intermittent)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Drug Reaction
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Dry Mouth
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Dry Skin (Bl Le)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Dysgeusia
|
42.9%
3/7 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
60.0%
3/5 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Dyspepsia (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (Intermittent)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea On Exertion
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
E.Coli In Stool
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Early Satiety
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
EBV Reactivation
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Eczematous Dermatitis
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Edema
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Edema (Limbs)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Edema BLE
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Edema LE
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Edema LLE
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Elevated Uric Acid
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Engraftment Syndrome
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Enterobactercloacae In Urine
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Enterovirus/Rhinovirus
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Eosinophilia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Epigastric Pain
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Esophagitis
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Eye disorders
Eye Burning
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Eye disorders
Eye Burning (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Eye disorders
Eye Irritation L
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Eye disorders
Eye Pain
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Eye disorders
Eyelid Lesion
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Facial Edema
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Fatigue
|
71.4%
5/7 • Number of events 9 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
42.9%
3/7 • Number of events 5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
60.0%
3/5 • Number of events 13 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
50.0%
2/4 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
57.1%
4/7 • Number of events 4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 6 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Fecal Urgency
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Fever
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
60.0%
3/5 • Number of events 13 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Fever (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Fever/Chills
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Fevers (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Flank Pain (Right Side)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Flu Like Symptoms
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Follicular Erythema Rash
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Gastritis
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
GGT Increased
|
71.4%
5/7 • Number of events 10 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
80.0%
4/5 • Number of events 7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
60.0%
3/5 • Number of events 13 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Graft Failure/Loss
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Haptoglobin Decreased
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Headache (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Ear and labyrinth disorders
Hearing Impaired
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Cardiac disorders
Heart Failure, Systolic
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Renal and urinary disorders
Hematuria/Dysuria/Fever
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Vascular disorders
Hot Flashes
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Human Enterovirus/Rhinovirus
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Human Metapneumovirus
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Hyperglycemia Non-Fasting
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 8 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Hyperglycemia Non-Fasting (Intermittent)
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 6 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.3%
1/7 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
57.1%
4/7 • Number of events 5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Hyperphospatemia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Endocrine disorders
Hyperthyroidism
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Endocrine disorders
Hypoadrenal
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Endocrine disorders
Hypocortosolism
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Hypogammaglobulinemia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Hypoglycemia (Intermittent)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.6%
2/7 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
57.1%
4/7 • Number of events 15 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
50.0%
2/4 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
28.6%
2/7 • Number of events 6 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 20 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Hypomagnesemia (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.6%
2/7 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 8 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 8 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Vascular disorders
Hypotension (Orthostatic)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Endocrine disorders
Hypothyroidism
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
IGG Decreased
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Immune System Disorder-Hypogammaglobulinemia
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Infection (+ Blood Culture)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Infection Adenovirus Reactivation
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Infection RSV
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Infection Sinus
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Influenza A
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Infusion Reaction (Sob, Feeling Cold, Rigors)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Infusion Related (Macupapular Rash)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
50.0%
2/4 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Intermittent Vomiting
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Eye disorders
Itchy Eyes (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Joint Pain (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Joint Range Of Motion Decreased (R Shoulder Rotator Cuff)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Joint Range Of Motion Decreased(Shoulder And Knees)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
LD Increased
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
50.0%
2/4 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Left Arm Tingling
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Vascular disorders
Left Jugular Deep Vein Thrombosis
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Leg Cramps (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Leukocytosis
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Leukopenia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Lip Infection
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Lipase Increased
|
28.6%
2/7 • Number of events 10 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
50.0%
2/4 • Number of events 9 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Localized Edema
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Localized Edema (Left Arm)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Loose Stools (Pudding)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Lung Infection (Fungal Species: Mycelia Sterilia)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Lung Infection (Pna / Boop)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Lung Infection (Pna)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Lung Nodule
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Malaise
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Metapneumovirus And Coronavirus
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Mrsa Nasal Colonization
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Mucousy Stool (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Myalgia (Left Leg)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Myalgia Bilateral Lower Extremities
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Myalgias
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Myopathy (Muscle Weakness Lower Limb)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Myositis /Polymyalgia Secondary To Late Effects Of Ipilimumab
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
71.4%
5/7 • Number of events 10 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
50.0%
2/4 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
57.1%
4/7 • Number of events 4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Nausea (Dry Heaves)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Nausea (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Neuropathic Leg Pain
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Neutropenia
|
71.4%
5/7 • Number of events 34 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
85.7%
6/7 • Number of events 46 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
100.0%
5/5 • Number of events 23 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
50.0%
2/4 • Number of events 4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
57.1%
4/7 • Number of events 18 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
100.0%
5/5 • Number of events 23 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Neutropenia (Intermittent)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Neutrophil Count Increased
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodule Occipital
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Norovirus
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Oral Candidiasis
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Oral Mucositis
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Vascular disorders
Orthostatic Hypotension (Adrenal Dysfunction)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Otitis Media (Right)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
General disorders
Pain
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain Calf
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain Joint
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain Rib
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain Right Jaw
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain Right Lower Quadrant
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain To L Flank/Rib
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain-Bl Leg Pain Chronic Back Compressed Spinal Fracture
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Pancreatitis
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Papular Rash
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Parainfluenza A
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Parainfluenza
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Parainfluenza 1
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Parainfluenza 3 Lung Infection
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Paresthesia Hands
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pelvis Pain
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Reproductive system and breast disorders
Penile Lesion
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Peripheral Sensory Neuropathy (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Perirectal Abscess
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Phosphorous Increased
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Vascular disorders
Postural Hypotension
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Pressure Ulcer
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Number of events 6 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
60.0%
3/5 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
42.9%
3/7 • Number of events 4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Pruritus (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
42.9%
3/7 • Number of events 4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash (Acneiform/Erythematous)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash (Around L Nipple)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash (Contact Dermatitis)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash (Erythematous)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash (Pruritic) Thighs
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash (Pruritic) Upper Chest
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash (R Hip)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash (Right Hand)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform/Erythematous
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash Facial
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash Hands, Back
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash Maculopapular
|
28.6%
2/7 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 6 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic (General)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash, Acneiform/Erythematous
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rashes (Macular)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rashes (Papular Lower Lid)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rashes Acneiform
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rashes Forehead
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rashes Papular
|
28.6%
2/7 • Number of events 4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Rashes Papular Chin
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Recurrent Clostridium Difficile Diarrhea
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Reflux
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Rhinovirus/Enterovirus (Rpp Virus)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Right Hip Pain
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Right Upper Lobe Nodular Opacity
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Vascular disorders
Rising Blood Pressure
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Shingles
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Short Term Memory Loss
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Injury, poisoning and procedural complications
Skin Biopsy Right Ear
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin Pigmentation
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin Tissue Pustules(Folliculitis)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Metabolism and nutrition disorders
Steroid Induced Hyperglycemia (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Musculoskeletal and connective tissue disorders
Stiff Neck
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Stomach Discomfort/Reflux
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Tachycardia
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Thrombocytopenia
|
85.7%
6/7 • Number of events 23 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
85.7%
6/7 • Number of events 32 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
60.0%
3/5 • Number of events 7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
75.0%
3/4 • Number of events 4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
42.9%
3/7 • Number of events 21 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
60.0%
3/5 • Number of events 40 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Thrush
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Tingling Painful Hands
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Tremors
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Nervous system disorders
Tremors (Hand)
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Endocrine disorders
TSH Increased
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Upper Respiratory Infection
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Renal and urinary disorders
Urinary Burning
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Renal and urinary disorders
Urinary Disorder Straining
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Renal and urinary disorders
Urinary Disorder Unable To Urinate
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Renal and urinary disorders
Urinary Frequency
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Renal and urinary disorders
Urinary Tract Infection (Enterobactercloacae Complex)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Renal and urinary disorders
Urinary Tract Pain
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Uriticaria
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
25.0%
1/4 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Infections and infestations
Viral/Superimposed Bacterial Pneumonia
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
57.1%
4/7 • Number of events 5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 3 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Gastrointestinal disorders
Vomiting (Intermittent)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
20.0%
1/5 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
WBC Increased
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Investigations
Weight Loss
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
28.6%
2/7 • Number of events 18 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
40.0%
2/5 • Number of events 2 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
|
Skin and subcutaneous tissue disorders
Wound, Sacral
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
14.3%
1/7 • Number of events 1 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/4 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/7 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
0.00%
0/5 • From Day 1 Week 1 of combined checkpoint therapy through the end of the safety-reporting period of 100 days after the last dose of study therapy (approximately 40 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place