Trial Outcomes & Findings for A Phase 1 Trial of CD25/Treg-depleted DLI Plus Ipilimumab for Myeloid Disease Relapse After Matched-HCT (NCT NCT03912064)
NCT ID: NCT03912064
Last Updated: 2026-01-05
Results Overview
The primary objective of this study is to determine the safety (MTD) of CD25/Treg-depleted donor lymphocyte infusion (DLI) plus Ipilimumab in patients with myeloid relapse after matched-HCT. Participants will be evaluated for dose limiting toxicities (DLTs) at day 43. DLTs explained within section 5.4 of the protocol.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Day 43 (6 weeks)
Results posted on
2026-01-05
Participant Flow
Participant milestones
| Measure |
Dose Level: 0
1 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 1
3 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 2
10 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
6
|
1
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
17
|
6
|
1
|
Reasons for withdrawal
| Measure |
Dose Level: 0
1 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 1
3 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 2
10 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
|
Overall Study
Adverse reaction to Ipilimumab
|
2
|
0
|
1
|
|
Overall Study
Progression/Relapse
|
7
|
3
|
0
|
|
Overall Study
Prolonged treatment delays
|
3
|
2
|
0
|
|
Overall Study
Prohibited concomitant treatments
|
3
|
1
|
0
|
Baseline Characteristics
A Phase 1 Trial of CD25/Treg-depleted DLI Plus Ipilimumab for Myeloid Disease Relapse After Matched-HCT
Baseline characteristics by cohort
| Measure |
Dose Level: 0
n=18 Participants
1 mg/kg of Ipilimumab will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 1
n=6 Participants
3 mg/kg of Ipilimumab will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 2
n=1 Participants
10 mg/kg of Ipilimumab will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=9 Participants
|
6 Participants
n=32 Participants
|
1 Participants
n=18 Participants
|
22 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
1 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=78 Participants
|
|
Age, Continuous
|
65 years
n=9 Participants
|
57.5 years
n=32 Participants
|
68 years
n=18 Participants
|
65 years
n=78 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=9 Participants
|
4 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
11 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=9 Participants
|
2 Participants
n=32 Participants
|
1 Participants
n=18 Participants
|
14 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Unknown/Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=78 Participants
|
PRIMARY outcome
Timeframe: Day 43 (6 weeks)The primary objective of this study is to determine the safety (MTD) of CD25/Treg-depleted donor lymphocyte infusion (DLI) plus Ipilimumab in patients with myeloid relapse after matched-HCT. Participants will be evaluated for dose limiting toxicities (DLTs) at day 43. DLTs explained within section 5.4 of the protocol.
Outcome measures
| Measure |
Dose Level: 2
10 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 0
n=25 Participants
1 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 1
3 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) for DLI
|
—
|
30000000 cells/kg
|
—
|
PRIMARY outcome
Timeframe: Day 43 (6 weeks)The primary objective of this study is to determine the safety (MTD) of CD25/Treg-depleted donor lymphocyte infusion (DLI) plus Ipilimumab in patients with myeloid relapse after matched-HCT. Participants will be evaluated for dose limiting toxicities (DLTs) at day 43. DLTs explained within section 5.4 of the protocol.
Outcome measures
| Measure |
Dose Level: 2
10 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 0
n=25 Participants
1 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 1
3 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) for Ipilimumab
|
—
|
1 mg/kg
|
—
|
SECONDARY outcome
Timeframe: Day 43 (6 weeks)Complete remission will be evaluated for each disease, along with duration of complete remission. AML morphological complete remission can be found in Appendix E (E.1.1.), and Relapse from CR/CRi is in E.1.3. MDS/MPN complete remission criteria is found in Appendix F (F.1.1), and criteria for relapse is found in F.1.5.
Outcome measures
| Measure |
Dose Level: 2
n=1 Participants
10 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 0
n=18 Participants
1 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 1
n=6 Participants
3 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
|---|---|---|---|
|
Response Rate as Determined by Complete Remission (CR) and CR With Incomplete Count Recovery (CRi)
|
0 Participants
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 92 and Week 60Duration of time from start of treatment to time of objective disease progression or death, whichever comes first. AML progressive disease is defined in Appendix E (E.1.7.), and criteria for MDS/MPN is in Appendix F (F.1.4.).
Outcome measures
| Measure |
Dose Level: 2
n=1 Participants
10 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 0
n=18 Participants
1 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 1
n=6 Participants
3 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
|---|---|---|---|
|
Progression Free Survival
Day 92
|
NA percentage of participants
Progression event (died without progression) at day 65, Sample size too small to estimate the rate and CI
|
50 percentage of participants
Interval 27.0 to 73.0
|
83 percentage of participants
Interval 53.0 to 100.0
|
|
Progression Free Survival
Week 60
|
NA percentage of participants
Progression event (died without progression) at day 65, Sample size too small to estimate the rate and CI
|
33 percentage of participants
Interval 11.0 to 55.0
|
17 percentage of participants
Interval 0.0 to 47.0
|
SECONDARY outcome
Timeframe: Day 92 and Week 60Duration of time from start of treatment to time of death.
Outcome measures
| Measure |
Dose Level: 2
n=1 Participants
10 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 0
n=18 Participants
1 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 1
n=6 Participants
3 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
|---|---|---|---|
|
Overall Survival
Day 92
|
NA percentage of participants
Died at day 65, Sample size too small to estimate the rate and CI
|
89 percentage of participants
Interval 75.0 to 100.0
|
100 percentage of participants
No death before 150 days, cannot estimate CI
|
|
Overall Survival
Week 60
|
NA percentage of participants
Died at day 65, Sample size too small to estimate the rate and CI
|
61 percentage of participants
Interval 37.0 to 83.0
|
67 percentage of participants
Interval 29.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 92Incidence of aGVHD will be measured at the below time point, and grading severity of aGVHD will be standardized using the chart and information in Appendix C.
Outcome measures
| Measure |
Dose Level: 2
n=1 Participants
10 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 0
n=18 Participants
1 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 1
n=6 Participants
3 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
|---|---|---|---|
|
Incidence of Acute GVHD Rates
|
1 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 92Provider will assess study subject for severity of cGVHD per 2014 NIH consensus criteria at day 92.
Outcome measures
| Measure |
Dose Level: 2
n=1 Participants
10 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 0
n=18 Participants
1 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 1
n=6 Participants
3 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
|---|---|---|---|
|
Incidence of Chronic GVHD Rates
|
0 Participants
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 92Severity of aGVHD will be measured at the below time point, and grading severity of aGVHD will be standardized using the chart and information in Appendix C per Harris et al, 2016 "GVHD Target Organ Staging", where 0 is no GVHD and 4 is severe. For the data table below: Grade I-IV reports any incidence of aGVHD, Grade II-IV reports the number of subjects who developed grade II, III, and IV aGVHD and Grade III-IV reports the number of subjects who developed Grade III and IV aGHVD. Grade 0: No stage 1-4 of any organ. Grade I: Stage 1-2 skin without liver, upper GI, or lower GI involvement. Grade II: Stage 3 rash and/or stage 1 liver and/or stage 1 upper GI and/or stage 1 lower GI. Grade III: Stage 2-3 liver and/or stage 2-3 lower GI, with stage 0-3 skin and/or stage 0-1 upper GI. Grade IV: Stage 4 skin, liver, or lower GI involvement, with stage 0-1 upper GI.
Outcome measures
| Measure |
Dose Level: 2
n=1 Participants
10 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 0
n=18 Participants
1 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 1
n=6 Participants
3 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
|---|---|---|---|
|
Severity of Acute GVHD Rates
Grade I-IV aGVHD
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Severity of Acute GVHD Rates
Grade II-IV aGVHD
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Severity of Acute GVHD Rates
Grade III-IV aGVHD
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 92Provider will assess study subject for severity of cGVHD per 2014 NIH consensus criteria at day 92.
Outcome measures
| Measure |
Dose Level: 2
n=1 Participants
10 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 0
n=18 Participants
1 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 1
n=6 Participants
3 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
|---|---|---|---|
|
Severity of Chronic GVHD Rates
Mild cGVHD
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Severity of Chronic GVHD Rates
Moderate cGVHD
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Severity of Chronic GVHD Rates
Severe cGVHD
|
0 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
Dose Level: 2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Dose Level: 0
Serious events: 4 serious events
Other events: 18 other events
Deaths: 7 deaths
Dose Level: 1
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Dose Level: 2
n=1 participants at risk
10 mg/kg of Ipilimumab will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 0
n=18 participants at risk
1 mg/kg of Ipilimumab will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 1
n=6 participants at risk
3 mg/kg of Ipilimumab will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
|---|---|---|---|
|
General disorders
Fever
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Nervous system disorders
Encephalopathy
|
100.0%
1/1 • Number of events 1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Number of events 1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
Other adverse events
| Measure |
Dose Level: 2
n=1 participants at risk
10 mg/kg of Ipilimumab will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 0
n=18 participants at risk
1 mg/kg of Ipilimumab will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
Dose Level: 1
n=6 participants at risk
3 mg/kg of Ipilimumab will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
55.6%
10/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
1/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Eye disorders
Dry eye
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Eye disorders
Floaters
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
11.1%
2/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
27.8%
5/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
1/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
11.1%
2/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
11.1%
2/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
33.3%
2/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
11.1%
2/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
General disorders
Chills
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
General disorders
Edema face
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
General disorders
Edema limbs
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
General disorders
Fatigue
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
66.7%
12/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
1/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
General disorders
Fever
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
11.1%
2/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
General disorders
Flu like symptoms
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
General disorders
Malaise
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Immune system disorders
Immune system disorders - Other, specify
|
100.0%
1/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
11.1%
2/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
33.3%
2/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Infections and infestations
Bacteremia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
11.1%
2/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
1/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
11.1%
2/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Infections and infestations
Lung infection
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Infections and infestations
Otitis media
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
11.1%
2/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
11.1%
2/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
1/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
61.1%
11/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
66.7%
4/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Investigations
Alkaline phosphatase increased
|
100.0%
1/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
38.9%
7/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
50.0%
3/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
50.0%
9/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
50.0%
3/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
33.3%
6/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
1/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Investigations
Blood lactate dehydrogenase increased
|
100.0%
1/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
44.4%
8/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
1/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Investigations
CPK increased
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
11.1%
2/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Investigations
Creatinine increased
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
22.2%
4/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
33.3%
2/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Investigations
Lipase increased
|
100.0%
1/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
33.3%
6/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
1/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
61.1%
11/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
1/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
66.7%
12/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
33.3%
2/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Investigations
Serum amylase increased
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Investigations
Weight loss
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
1/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Investigations
White blood cell decreased
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
61.1%
11/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
22.2%
4/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
1/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
22.2%
4/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
3/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
1/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
3/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
11.1%
2/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
3/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
11.1%
2/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
11.1%
2/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
1/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Nervous system disorders
Ataxia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
3/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
11.1%
2/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
3/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
1/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
33.3%
2/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Psychiatric disorders
Confusion
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
11.1%
2/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Psychiatric disorders
Delirium
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
1/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Reproductive system and breast disorders
Uterine pain
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
22.2%
4/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
11.1%
2/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
1/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
22.2%
4/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
16.7%
1/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
100.0%
1/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
27.8%
5/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
33.3%
2/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
22.2%
4/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
22.2%
4/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/1 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
5.6%
1/18 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
0.00%
0/6 • Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.
An adverse event (AE) is any undesirable sign, symptom or medical condition or experience that develops or worsens in severity after starting the first dose of study treatment or any procedure specified in the protocol, even if the event is not considered to be related to the study. Infection: CTCAE gr 3 or less. And immune-related events (e.g. diarrhea, pruritus, rash, endocrinopathies) that respond to corticosteroids and improve to grade 1 or less with steroids: CTCAE gr 3 or less
|
Additional Information
John Koreth, MD, PhD, MBBS
Dana-Farber Cancer Institute
Phone: 617-632-3470
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place