Trial Outcomes & Findings for Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer (NCT NCT02778685)
NCT ID: NCT02778685
Last Updated: 2026-02-24
Results Overview
Assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Response rate was defined as the proportion of patients who had a partial or complete response to therapy.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Up to 36 months
Results posted on
2026-02-24
Participant Flow
A total of 47 patients were accrued. Three patients were not evaluable. Consequently, 44 patients were included in the final analysis.
A total of 47 patients were accrued. Three patients were not evaluable. Consequently, 44 patients were included in the final analysis.
Participant milestones
| Measure |
Cohorts 1 (Letrozole + Palbociclib) on C1D1 and Add Pembrolizumab After 6 Months
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. 6 months later, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2 (Patients Start Letrozole + Palbociclib + Pembrolizumab as Upfront Therapy on C1D1)
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3 (Letrozole, Palbociclib, Fulvestrant, Pembrolizumab)
Patients receive either letrozole PO QD on days -28 to -1 and days 1-28, or fulvestrant on days -28, -14, and day 1 of subsequent cycles. Patients also receive palbociclib PO QD for 3 weeks. Cycles with palbociclib, and letrozole or fulvestrant repeat every 28 days in the absence disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
19
|
24
|
|
Overall Study
COMPLETED
|
4
|
16
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Cohorts 1 (Letrozole + Palbociclib) on C1D1 and Add Pembrolizumab After 6 Months
n=4 Participants
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. 6 months later, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2 (Patients Start Letrozole + Palbociclib + Pembrolizumab as Upfront Therapy on C1D1)
n=16 Participants
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3 (Letrozole, Palbociclib, Fulvestrant, Pembrolizumab)
n=24 Participants
Patients receive either letrozole PO QD on days -28 to -1 and days 1-28, or fulvestrant on days -28, -14, and day 1 of subsequent cycles. Patients also receive palbociclib PO QD for 3 weeks. Cycles with palbociclib, and letrozole or fulvestrant repeat every 28 days in the absence disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=484 Participants
|
|
Age, Continuous
|
48 years
n=58 Participants
|
55 years
|
55.5 years
n=1 Participants
|
55 years
n=484 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=58 Participants
|
16 Participants
|
23 Participants
n=1 Participants
|
43 Participants
n=484 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=58 Participants
|
0 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=484 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=58 Participants
|
6 Participants
|
5 Participants
n=1 Participants
|
12 Participants
n=484 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=58 Participants
|
10 Participants
|
19 Participants
n=1 Participants
|
32 Participants
n=484 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=484 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=58 Participants
|
4 Participants
|
6 Participants
n=1 Participants
|
12 Participants
n=484 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=484 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=58 Participants
|
0 Participants
|
3 Participants
n=1 Participants
|
3 Participants
n=484 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=58 Participants
|
12 Participants
|
13 Participants
n=1 Participants
|
26 Participants
n=484 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=484 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=58 Participants
|
0 Participants
|
2 Participants
n=1 Participants
|
3 Participants
n=484 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=58 Participants
|
16 participants
|
24 participants
n=1 Participants
|
44 participants
n=484 Participants
|
PRIMARY outcome
Timeframe: Up to 36 monthsAssessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Response rate was defined as the proportion of patients who had a partial or complete response to therapy.
Outcome measures
| Measure |
Cohorts 1 (Letrozole + Palbociclib) on C1D1 and Add Pembrolizumab After 6 Months
n=4 Participants
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. 6 months later, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2 (Patients Start Letrozole + Palbociclib + Pembrolizumab as Upfront Therapy on C1D1)
n=16 Participants
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3 (Letrozole, Palbociclib, Fulvestrant, Pembrolizumab)
n=24 Participants
Patients receive either letrozole PO QD on days -28 to -1 and days 1-28, or fulvestrant on days -28, -14, and day 1 of subsequent cycles. Patients also receive palbociclib PO QD for 3 weeks. Cycles with palbociclib, and letrozole or fulvestrant repeat every 28 days in the absence disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Response Rate (Complete Response or Partial Response)
|
2 Participants
|
9 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment.Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4. Adverse events will be analyzed including but not limited to all adverse events (AEs), serious adverse events (SAEs), fatal AEs, and laboratory changes. Immune-related adverse events (irAEs) will also be collected.
Outcome measures
| Measure |
Cohorts 1 (Letrozole + Palbociclib) on C1D1 and Add Pembrolizumab After 6 Months
n=4 Participants
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. 6 months later, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2 (Patients Start Letrozole + Palbociclib + Pembrolizumab as Upfront Therapy on C1D1)
n=16 Participants
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3 (Letrozole, Palbociclib, Fulvestrant, Pembrolizumab)
n=24 Participants
Patients receive either letrozole PO QD on days -28 to -1 and days 1-28, or fulvestrant on days -28, -14, and day 1 of subsequent cycles. Patients also receive palbociclib PO QD for 3 weeks. Cycles with palbociclib, and letrozole or fulvestrant repeat every 28 days in the absence disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Incidence of Adverse Events
|
4 Participants
|
16 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Up to 36 monthsAssessed using RECIST version 1.1. Complete response rate was defined as the proportion of patients who had a complete response to therapy.
Outcome measures
| Measure |
Cohorts 1 (Letrozole + Palbociclib) on C1D1 and Add Pembrolizumab After 6 Months
n=4 Participants
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. 6 months later, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2 (Patients Start Letrozole + Palbociclib + Pembrolizumab as Upfront Therapy on C1D1)
n=16 Participants
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3 (Letrozole, Palbociclib, Fulvestrant, Pembrolizumab)
n=24 Participants
Patients receive either letrozole PO QD on days -28 to -1 and days 1-28, or fulvestrant on days -28, -14, and day 1 of subsequent cycles. Patients also receive palbociclib PO QD for 3 weeks. Cycles with palbociclib, and letrozole or fulvestrant repeat every 28 days in the absence disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Complete Response Rate
|
0 Participants
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 36 months. Time from documentation of tumor response to disease progression or deathAssessed using RECIST version 1.1. Duration of response estimates were calculated with the Kaplan-Meier method.
Outcome measures
| Measure |
Cohorts 1 (Letrozole + Palbociclib) on C1D1 and Add Pembrolizumab After 6 Months
n=4 Participants
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. 6 months later, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2 (Patients Start Letrozole + Palbociclib + Pembrolizumab as Upfront Therapy on C1D1)
n=16 Participants
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3 (Letrozole, Palbociclib, Fulvestrant, Pembrolizumab)
n=24 Participants
Patients receive either letrozole PO QD on days -28 to -1 and days 1-28, or fulvestrant on days -28, -14, and day 1 of subsequent cycles. Patients also receive palbociclib PO QD for 3 weeks. Cycles with palbociclib, and letrozole or fulvestrant repeat every 28 days in the absence disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Duration of Response
|
NA months
Median (95% CI) DOR is not reached due to the insufficient number of participants with events.
|
27.6 months
Interval 4.2 to 76.8
|
27.1 months
Interval 8.3 to
Upper limit not reached.
|
SECONDARY outcome
Timeframe: Up to 36 months. From start of treatment to time of progression or death, whichever occurs first.Progression was assessed using RECIST version 1.1. Progression-free survival estimates were calculated with the Kaplan-Meier method.
Outcome measures
| Measure |
Cohorts 1 (Letrozole + Palbociclib) on C1D1 and Add Pembrolizumab After 6 Months
n=4 Participants
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. 6 months later, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2 (Patients Start Letrozole + Palbociclib + Pembrolizumab as Upfront Therapy on C1D1)
n=16 Participants
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3 (Letrozole, Palbociclib, Fulvestrant, Pembrolizumab)
n=24 Participants
Patients receive either letrozole PO QD on days -28 to -1 and days 1-28, or fulvestrant on days -28, -14, and day 1 of subsequent cycles. Patients also receive palbociclib PO QD for 3 weeks. Cycles with palbociclib, and letrozole or fulvestrant repeat every 28 days in the absence disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Progression Free Survival
|
NA months
Median (95% CI) PFS is not reached due to the insufficient number of participants with events.
|
25.2 months
Interval 5.3 to
Upper limit not reached.
|
29.1 months
Interval 11.2 to
Upper limit not reached.
|
SECONDARY outcome
Timeframe: Up to 36 months. From start of treatment to time of death.Overall survival estimates were calculated with the Kaplan-Meier method.
Outcome measures
| Measure |
Cohorts 1 (Letrozole + Palbociclib) on C1D1 and Add Pembrolizumab After 6 Months
n=4 Participants
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. 6 months later, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2 (Patients Start Letrozole + Palbociclib + Pembrolizumab as Upfront Therapy on C1D1)
n=16 Participants
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3 (Letrozole, Palbociclib, Fulvestrant, Pembrolizumab)
n=24 Participants
Patients receive either letrozole PO QD on days -28 to -1 and days 1-28, or fulvestrant on days -28, -14, and day 1 of subsequent cycles. Patients also receive palbociclib PO QD for 3 weeks. Cycles with palbociclib, and letrozole or fulvestrant repeat every 28 days in the absence disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Survival
|
NA months
Median (95% CI) OS is not reached due to the insufficient number of participants with events.
|
36.9 months
Interval 36.9 to
Upper limit not reached.
|
NA months
Interval 37.6 to
Median OS is not reached due to the insufficient number of participants with events; upper limit also not reached.
|
SECONDARY outcome
Timeframe: Up to 36 months. From start of treatment to toxicity-related study discontinuation or progression.Time to treatment failure estimates were calculated with the Kaplan-Meier method.
Outcome measures
| Measure |
Cohorts 1 (Letrozole + Palbociclib) on C1D1 and Add Pembrolizumab After 6 Months
n=4 Participants
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. 6 months later, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2 (Patients Start Letrozole + Palbociclib + Pembrolizumab as Upfront Therapy on C1D1)
n=16 Participants
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3 (Letrozole, Palbociclib, Fulvestrant, Pembrolizumab)
n=24 Participants
Patients receive either letrozole PO QD on days -28 to -1 and days 1-28, or fulvestrant on days -28, -14, and day 1 of subsequent cycles. Patients also receive palbociclib PO QD for 3 weeks. Cycles with palbociclib, and letrozole or fulvestrant repeat every 28 days in the absence disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Time to Treatment Failure
|
7.8 months
Interval 4.1 to
Upper limit not reached.
|
26.2 months
Interval 5.3 to 59.5
|
29.1 months
Interval 11.2 to
Upper limit not reached.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 36 monthsAssessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Clinical benefit was defined as the proportion of patients who had a partial response or complete response to therapy, or stable disease.
Outcome measures
| Measure |
Cohorts 1 (Letrozole + Palbociclib) on C1D1 and Add Pembrolizumab After 6 Months
n=4 Participants
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. 6 months later, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2 (Patients Start Letrozole + Palbociclib + Pembrolizumab as Upfront Therapy on C1D1)
n=16 Participants
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3 (Letrozole, Palbociclib, Fulvestrant, Pembrolizumab)
n=24 Participants
Patients receive either letrozole PO QD on days -28 to -1 and days 1-28, or fulvestrant on days -28, -14, and day 1 of subsequent cycles. Patients also receive palbociclib PO QD for 3 weeks. Cycles with palbociclib, and letrozole or fulvestrant repeat every 28 days in the absence disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Clinical Benefit
|
4 Participants
|
14 Participants
|
22 Participants
|
Adverse Events
Cohorts 1 (Letrozole + Palbociclib) on C1D1 and Add Pembrolizumab After 6 Months
Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths
Cohort 2 (Patients Start Letrozole + Palbociclib + Pembrolizumab as Upfront Therapy on C1D1)
Serious events: 6 serious events
Other events: 16 other events
Deaths: 10 deaths
Cohort 3 (Letrozole, Palbociclib, Fulvestrant, Pembrolizumab)
Serious events: 8 serious events
Other events: 23 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Cohorts 1 (Letrozole + Palbociclib) on C1D1 and Add Pembrolizumab After 6 Months
n=4 participants at risk
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. 6 months later, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2 (Patients Start Letrozole + Palbociclib + Pembrolizumab as Upfront Therapy on C1D1)
n=16 participants at risk
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3 (Letrozole, Palbociclib, Fulvestrant, Pembrolizumab)
n=24 participants at risk
Patients receive either letrozole PO QD on days -28 to -1 and days 1-28, or fulvestrant on days -28, -14, and day 1 of subsequent cycles. Patients also receive palbociclib PO QD for 3 weeks. Cycles with palbociclib, and letrozole or fulvestrant repeat every 28 days in the absence disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Duodenal perforation
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
COVID-19 positive
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
VIRAL GASTROENTERITIS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
ALTERED MENTAL STATUS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
PYELONEPHRITIS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
Cohorts 1 (Letrozole + Palbociclib) on C1D1 and Add Pembrolizumab After 6 Months
n=4 participants at risk
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. 6 months later, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2 (Patients Start Letrozole + Palbociclib + Pembrolizumab as Upfront Therapy on C1D1)
n=16 participants at risk
Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 3 (Letrozole, Palbociclib, Fulvestrant, Pembrolizumab)
n=24 participants at risk
Patients receive either letrozole PO QD on days -28 to -1 and days 1-28, or fulvestrant on days -28, -14, and day 1 of subsequent cycles. Patients also receive palbociclib PO QD for 3 weeks. Cycles with palbociclib, and letrozole or fulvestrant repeat every 28 days in the absence disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
4/4 • Number of events 6 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
87.5%
14/16 • Number of events 102 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
41.7%
10/24 • Number of events 39 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Hematochezia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
increased free thyroxine
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
leukopenia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Chest pain - cardiac
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
75.0%
3/4 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
8/16 • Number of events 22 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
6/24 • Number of events 11 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.8%
3/16 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
POUNDING IN THE RIGHT EAR
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
3/24 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
decreased hearing on right side
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
ear infection
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
hyperacusis
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Endocrine disorders
DEC T3 LEVELS
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Endocrine disorders
Decreased TSH
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Endocrine disorders
EUTHYROID SICK SYNDROME
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
3/24 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.8%
3/16 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Endocrine disorders
INC PHOSPHATE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.8%
3/16 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Endocrine disorders
Increased free thyroxine
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Endocrine disorders
TSH increased
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Blurred vision
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
DIPLOPIA
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Dark Spot in Vision
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
EYELID TWITCHES
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Floaters
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
LEFT EYE DEVIATION TOWARDS THE MIDLINE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Left Eye Blepharospasm, Intermittent
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Retinopathy
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
SUBCONJUNCTIVAL SWELLING OF THE LEFT EYE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
TWITCHING OF THE EYE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
VISION CHANGES AFTER MIGRAINE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Watering eyes
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
4/16 • Number of events 10 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
ANOSMIA
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
1/4 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
2/4 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
56.2%
9/16 • Number of events 15 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
8/24 • Number of events 17 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Anal irritation
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Ascites
|
50.0%
2/4 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
BLEEDING GUMS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
4/16 • Number of events 5 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
4/24 • Number of events 5 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Colitis
|
25.0%
1/4 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
37.5%
6/16 • Number of events 9 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
6/24 • Number of events 8 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
4/4 • Number of events 6 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
62.5%
10/16 • Number of events 28 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
58.3%
14/24 • Number of events 35 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diverticulosis
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.8%
3/16 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
FATTY LIVER
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
GERD
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
GI DISCOMFORT
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.8%
3/16 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastrointestinal Reflux
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
HEART BURN
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
LIGHT BLEED AFTER BM
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
MEDICATION INDUCED GASTROENTERITIS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.8%
3/16 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.8%
5/24 • Number of events 7 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
75.0%
12/16 • Number of events 31 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
45.8%
11/24 • Number of events 15 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
RHINORRHEA
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
SPLENOMEGALY
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
SWOLLEN GLANDS IN THE LEFT NECK
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Tongue Sores
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
43.8%
7/16 • Number of events 17 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
29.2%
7/24 • Number of events 10 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
BRITTLE NAILS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
BROKEN TOOTH
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
BUE numbness
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Bilateral Swelling on Feet/Ankles
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
CYST ON BUTTOCKS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
31.2%
5/16 • Number of events 11 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
6/24 • Number of events 6 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
DIAPHORESIS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema face
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.8%
3/16 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema limbs
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
4/16 • Number of events 6 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.8%
5/24 • Number of events 5 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
FLU LIKE SYMPTOMS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Facial pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
87.5%
14/16 • Number of events 30 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
58.3%
14/24 • Number of events 26 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
8/16 • Number of events 9 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
29.2%
7/24 • Number of events 8 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Flu like symptoms
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
4/16 • Number of events 5 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
6/24 • Number of events 6 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
GENERALIZED PAIN
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
4/16 • Number of events 6 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
GENERALIZED PAIN (INTERMITTENT)
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Gait disturbance
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
4/16 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
HEAT EXHAUSTION
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
HEAT STROKE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
INCREASED LDH
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
4/16 • Number of events 7 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
4/24 • Number of events 6 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Infusion related reaction
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Injection site reaction
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Irritability
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
LEFT ARM SWELLING
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
LEFT GLUTEAL SEBACEUS CYST
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
LIGHTHEADEDNESS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
LOWER EXTREMITY PAIN
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Localized edema
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Malaise
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Mouth Sore
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Muscle Cramping
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
NAIL CHANGES
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Neck edema
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
4/16 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
3/24 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
ORAL ABCESS ON GUM
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
ORAL THRUSH
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
PAIN FROM BURN
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
PAIN ON FOREHEAD
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
STIFFNESS AND PUFFINESS OF BOTH HANDS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
TONGUE SENSITIVITY
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
WATERY STOOL
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
acne
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
arthralgias, shoulder and chest
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
emotional
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
hyperosmia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
mouth sores
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
stress
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Immune system disorders
Seasonal Allergies
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Immune system disorders
Seasonal allergies, intermittent
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
ASYMPTOMATIC UTI
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Blistering Rash
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Breast infection
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
CANKER SORE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
COLD SORE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
COLD SORES
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
COVID TEST POSITIVE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
CYST REMOVAL
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Cold
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
DENTAL ABSCESS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Endocarditis infective
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Immune Hepatitis
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
LEFT BIT TOE INFECTION
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
LEFT INGUINAL CYST
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
MOUTH SORES
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
ONYCHOMYOSIS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
PLANTAR WART
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Upper respiratory infection
|
75.0%
3/4 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
37.5%
6/16 • Number of events 12 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
37.5%
9/24 • Number of events 19 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 7 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
4/24 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
VULVITIS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
YEAST INFECTION
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.8%
3/16 • Number of events 6 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
3/24 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
CUT ON LEFT PINKY FINGER
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
8/16 • Number of events 40 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
45.8%
11/24 • Number of events 23 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
56.2%
9/16 • Number of events 14 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
2/4 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
68.8%
11/16 • Number of events 40 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
41.7%
10/24 • Number of events 23 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
4/16 • Number of events 16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 15 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
COVID-19 POSITIVE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Cholesterol high
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine increased
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
37.5%
6/16 • Number of events 28 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
3/24 • Number of events 9 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
DECREASED PHOSPHATE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Hemoglobin increased
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
INCREASED AMMONIA
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
INCREASED LACTIC ACID
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
INCREASED T3
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
INR increased
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Increased LDH
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Increased Phosphate
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
LDH INCREASED
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
LDH increased
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphocyte count decreased
|
75.0%
3/4 • Number of events 5 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
87.5%
14/16 • Number of events 110 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
45.8%
11/24 • Number of events 70 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophil count decreased
|
50.0%
2/4 • Number of events 8 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
16/16 • Number of events 303 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
95.8%
23/24 • Number of events 336 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
50.0%
2/4 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
87.5%
14/16 • Number of events 129 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
41.7%
10/24 • Number of events 42 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
VITAMIN B12 DEFICIENCY
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight gain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.8%
3/16 • Number of events 5 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight loss
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
4/24 • Number of events 6 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
White blood cell decreased
|
75.0%
3/4 • Number of events 10 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
100.0%
16/16 • Number of events 327 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
91.7%
22/24 • Number of events 276 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Alkaline Phosphate Decreased
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Alkalosis
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
31.2%
5/16 • Number of events 8 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.8%
5/24 • Number of events 9 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
DECREASED FOLATE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
DECREASED VITAMIN D
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
31.2%
5/16 • Number of events 6 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATEMIA
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
4/16 • Number of events 10 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
37.5%
9/24 • Number of events 39 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
43.8%
7/16 • Number of events 9 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.8%
5/24 • Number of events 9 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 5 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
3/24 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
50.0%
2/4 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.8%
3/16 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
3/24 • Number of events 6 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
4/4 • Number of events 6 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
43.8%
7/16 • Number of events 30 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.8%
5/24 • Number of events 11 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
2/4 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
8/16 • Number of events 31 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
8/24 • Number of events 13 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
4/24 • Number of events 17 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
1/4 • Number of events 6 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
56.2%
9/16 • Number of events 32 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
8/24 • Number of events 23 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.8%
3/16 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
4/24 • Number of events 8 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
1/4 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
8/16 • Number of events 20 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
37.5%
9/24 • Number of events 21 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
50.0%
2/4 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
31.2%
5/16 • Number of events 17 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.8%
5/24 • Number of events 8 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
INCREASE PHOSPHORUS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
INCREASED PHOSPHATE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.8%
3/16 • Number of events 8 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.8%
5/24 • Number of events 7 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
INCREASED PHOSPHORUS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
INCREASEED PHOSPHATE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Increased serum Levels of Vitamin B12
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
POLYPHAGIA
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
VITAMINE D DEFICIENCY
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
increased phosphate
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
ANKLE SPRAIN
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
ARM SORENESS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
43.8%
7/16 • Number of events 13 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
37.5%
9/24 • Number of events 10 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
31.2%
5/16 • Number of events 16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.8%
5/24 • Number of events 9 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
BILATERAL FLANK PAIN
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
BILATERAL LOWER EXTREMITY TIGHTNESS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
BILATERAL WRIST PAIN
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
BL WRIST PAIN
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
2/4 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
4/16 • Number of events 10 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
8/24 • Number of events 12 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Bilateral Elbow Pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Bilateral Knee Pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
50.0%
2/4 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
37.5%
6/16 • Number of events 8 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
4/24 • Number of events 6 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
CARPAL TUNNEL
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
FOOT PAIN
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
4/16 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
HIP PAIN
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Hip Pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
JOINT PAIN
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
JOINT STIFFNESS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Jaw Pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased cervical spine
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Knee pain, Left
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
LEFT ARM PAIN
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
LEFT AXILLARY PAIN
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
LEFT HIP PAIN
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
LEFT SHOULDER PAIN
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
LEFT TOE PAIN
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
LUE PRONATOR DRIFT
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Left 10th Rib Fracture
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Left Shoulder Pain, Intermittent
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Lower Sacral Pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Lower extremities muscle cramping
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
MENISCAL TEAR
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE STRAIN RIGHT SHOULDER
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
2/4 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
31.2%
5/16 • Number of events 8 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
4/24 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
NECK AND SHOULDER PRESSURE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
NECK STIFFNESS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
4/16 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
2/4 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
8/16 • Number of events 20 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
29.2%
7/24 • Number of events 10 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
RIGHT CALF MUSCLE CRAMP
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
RIGHT ELBOW PAIN
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
RIGHT HIP PAIN
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
RIGHT SHOULDER PAIN
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Right Ankle Swelling Due to Fall
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
TINGLING IN THE FINGER TIPS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
TRIGGER FINGER
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
TROCHANTERIC BURSITIS OF THE LEFT HIP
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
shoulder pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervical Cancer
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Hemorrhage
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
ACUTE TOXIC ENCEPHALOPATHY
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
ALTERED MENTAL STATUS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Burning Sensation on 1st & 2nd Toe
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
DISORIENTATION
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
DROWSINESS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
37.5%
6/16 • Number of events 11 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
6/24 • Number of events 8 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
4/16 • Number of events 6 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
3/24 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Extrapyramidal disorder
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
43.8%
7/16 • Number of events 19 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
37.5%
9/24 • Number of events 13 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Intermittent Grogginess
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
2/4 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
37.5%
6/16 • Number of events 8 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
16.7%
4/24 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
TRIGEMINAL NERVE PAIN
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Tingling Sensation on Shoulder & Hand, Intermittent
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Tremor
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.8%
3/16 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
31.2%
5/16 • Number of events 5 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
BEHAVIORAL CHANGES
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Depression
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
EMOTIONAL
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
EMOTIONALLY NUMB
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
50.0%
2/4 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
43.8%
7/16 • Number of events 9 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
8/24 • Number of events 8 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
PANIC ATTACK
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Panic/Anxiety Attack
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
SAD
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
STRESS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Stress
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
TEARFUL
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
VIVID DREAMS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
ACUTE RENAL FAILURE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 6 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
CYST ON PELVIC US
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
DARK URINE WITH ODOR
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Dysuria(Burning sensation with urination
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
LEFT KIDNEY CYST
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
NOCTURIA
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Proteinuria
|
25.0%
1/4 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
31.2%
5/16 • Number of events 8 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
RENAL INSUFFICIENCY
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
URETHRAL PAIN WITH VOIDING
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
URINE ODOR
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urine discoloration
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
nocturia
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
BREAK THROUGH BLEEDING
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Breast pain
|
25.0%
1/4 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
31.2%
5/16 • Number of events 7 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
THICKENED ENDOMETRIUM
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
VAGINAL ATROPHY
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
VAGINAL ULCER
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Vaginal Atrophy
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Vaginal pain
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
ALERGIES
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Attack
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
50.0%
8/16 • Number of events 13 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
3/24 • Number of events 9 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
DRY NOSE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
43.8%
7/16 • Number of events 11 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 5 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.8%
3/16 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.8%
3/16 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
18.8%
3/16 • Number of events 8 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinopharyngitis
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
SEASONAL ALLERGIES
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
56.2%
9/16 • Number of events 13 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
3/24 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
TACHYPNEA
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
8.3%
2/24 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
ADULT ACNE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
2/4 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
25.0%
4/16 • Number of events 4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.8%
5/24 • Number of events 5 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
DERMATOGRPAHIA
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Dry Nose
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
20.8%
5/24 • Number of events 5 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
ECZEMATOUS DERMATITIS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Eczematous dermatitis
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
FACIAL FLUSHING
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
GLUTEAL FOLD FISSURE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
INJECTION SITE RASH
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
LEFT CHEST WALL RASH
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
LIPOMA
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
MILIA
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
MOSQUITO BITES
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Mouth Sores
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
PAIN AROUND PORT-A-CATH IN CHEST
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
PETECHIAE ON BILATERAL LOWER EXTREMITIES
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
PUFFINESS IN THE LEFT CHEEK
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
2/4 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
37.5%
6/16 • Number of events 12 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
33.3%
8/24 • Number of events 14 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
REDNESS FOREHEAD
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
RIGHT INGUINAL SKIN RASH
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
2/4 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
31.2%
5/16 • Number of events 16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
45.8%
11/24 • Number of events 18 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
SCRATCHES ON THE SKIN
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
SKIN ABRASION
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
SKIN ABRASION OF THE NOSE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin abrasion on left knee
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
TENDER BLISTER ON LEFT PALM
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
TOE NAIL CHANGES
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
TOPICAL FOLLICULITIS
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
VENOUS STASIS DERMATITIS
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
WHITE LESION ON THE FACE
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
discoloration and desquamation
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
portsite erythema
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
skin breakdown under lower abdominal folds
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/16 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hot flashes
|
50.0%
2/4 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
43.8%
7/16 • Number of events 12 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
29.2%
7/24 • Number of events 13 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
75.0%
12/16 • Number of events 129 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
29.2%
7/24 • Number of events 40 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
6.2%
1/16 • Number of events 1 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 2 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/4 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
12.5%
2/16 • Number of events 3 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
0.00%
0/24 • Adverse events (Grade 2 or higher) were assessed from the time of initial treatment until discontinuation of treatment, up to 30 days. SAEs and irAEs were collected for 90 days after the end of study treatment. All-Cause Mortality was assessed from start of treatment to time of death, up to 36 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place