Trial Outcomes & Findings for An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread (NCT NCT03459222)
NCT ID: NCT03459222
Last Updated: 2026-04-06
Results Overview
Laboratory test results are graded using the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Grade 3 = Severe or medically significant but not immediately life-threatening. Grade 4 = Life-threatening or disabling.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
229 participants
Primary outcome timeframe
From first dose (Day 1) and within 30 days of last dose of study therapy (up to approximately 69 months)
Results posted on
2026-04-06
Participant Flow
Participant milestones
| Measure |
1A-esc-480/160/25
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 25 mg once daily tablet (QD) orally.
|
1A-esc-480/160/50
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 50 mg once daily tablet (QD) orally.
|
1A-esc-480/160/100
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg once daily tablet (QD) orally.
|
1B-esc-160/480/1
Participants with Advanced Malignant Tumor were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2A-SCCHN IO Naive-160/480/100
Participants with immuno-oncology (IO)-naive second-line advanced or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2A-MEL 1L-160/480/100
Participants with first-line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2B-NSCLC 1L-160/480/1
Participants with first line advanced or metastatic non-small cell lung cancer (NSCLC) were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2B-MEL 1L-160/480/1
Participants with first line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
7
|
6
|
45
|
54
|
65
|
46
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
7
|
6
|
45
|
51
|
65
|
44
|
Reasons for withdrawal
| Measure |
1A-esc-480/160/25
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 25 mg once daily tablet (QD) orally.
|
1A-esc-480/160/50
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 50 mg once daily tablet (QD) orally.
|
1A-esc-480/160/100
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg once daily tablet (QD) orally.
|
1B-esc-160/480/1
Participants with Advanced Malignant Tumor were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2A-SCCHN IO Naive-160/480/100
Participants with immuno-oncology (IO)-naive second-line advanced or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2A-MEL 1L-160/480/100
Participants with first-line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2B-NSCLC 1L-160/480/1
Participants with first line advanced or metastatic non-small cell lung cancer (NSCLC) were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2B-MEL 1L-160/480/1
Participants with first line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Participant request to discontinue study treatment
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
|
Overall Study
Participant withdrew consent
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
0
|
|
Overall Study
Adverse event unrelated to study drug
|
0
|
0
|
0
|
0
|
4
|
0
|
8
|
2
|
|
Overall Study
Disease recurrence
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Other Reasons
|
0
|
1
|
2
|
0
|
0
|
4
|
2
|
2
|
|
Overall Study
Disease progression
|
2
|
2
|
3
|
6
|
30
|
25
|
32
|
13
|
|
Overall Study
Study drug toxicity
|
0
|
0
|
2
|
0
|
8
|
16
|
18
|
23
|
|
Overall Study
Maximum clinical benefit
|
1
|
0
|
0
|
0
|
0
|
3
|
2
|
4
|
Baseline Characteristics
An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread
Baseline characteristics by cohort
| Measure |
1A-esc-480/160/25
n=3 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 25 mg once daily tablet (QD) orally.
|
1A-esc-480/160/50
n=3 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 50 mg once daily tablet (QD) orally.
|
1A-esc-480/160/100
n=7 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg once daily tablet (QD) orally.
|
1B-esc-160/480/1
n=6 Participants
Participants with Advanced Malignant Tumor were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2A-SCCHN IO Naive-160/480/100
n=45 Participants
Participants with immuno-oncology (IO)-naive second-line advanced or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2A-MEL 1L-160/480/100
n=54 Participants
Participants with first-line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2B-NSCLC 1L-160/480/1
n=65 Participants
Participants with first line advanced or metastatic non-small cell lung cancer (NSCLC) were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2B-MEL 1L-160/480/1
n=46 Participants
Participants with first line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
Total
n=229 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=5 Participants
|
30 Participants
n=11 Participants
|
38 Participants
n=13 Participants
|
30 Participants
n=48 Participants
|
27 Participants
n=6 Participants
|
137 Participants
n=2 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=10 Participants
|
2 Participants
n=5 Participants
|
15 Participants
n=11 Participants
|
16 Participants
n=13 Participants
|
35 Participants
n=48 Participants
|
19 Participants
n=6 Participants
|
92 Participants
n=2 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=11 Participants
|
23 Participants
n=13 Participants
|
24 Participants
n=48 Participants
|
12 Participants
n=6 Participants
|
78 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=5 Participants
|
34 Participants
n=11 Participants
|
31 Participants
n=13 Participants
|
41 Participants
n=48 Participants
|
34 Participants
n=6 Participants
|
151 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=10 Participants
|
6 Participants
n=5 Participants
|
27 Participants
n=11 Participants
|
25 Participants
n=13 Participants
|
53 Participants
n=48 Participants
|
20 Participants
n=6 Participants
|
144 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
18 Participants
n=11 Participants
|
29 Participants
n=13 Participants
|
12 Participants
n=48 Participants
|
26 Participants
n=6 Participants
|
85 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=10 Participants
|
5 Participants
n=5 Participants
|
36 Participants
n=11 Participants
|
41 Participants
n=13 Participants
|
61 Participants
n=48 Participants
|
46 Participants
n=6 Participants
|
200 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
2 Participants
n=48 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=11 Participants
|
3 Participants
n=13 Participants
|
2 Participants
n=48 Participants
|
0 Participants
n=6 Participants
|
10 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=11 Participants
|
10 Participants
n=13 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=6 Participants
|
13 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: From first dose (Day 1) and within 30 days of last dose of study therapy (up to approximately 69 months)Population: All treated participants. Only participants available at timepoint were included in the analysis.
Laboratory test results are graded using the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Grade 3 = Severe or medically significant but not immediately life-threatening. Grade 4 = Life-threatening or disabling.
Outcome measures
| Measure |
1A-esc-480/160/25
n=3 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 25 mg once daily tablet (QD) orally.
|
1A-esc-480/160/50
n=3 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 50 mg once daily tablet (QD) orally.
|
1A-esc-480/160/100
n=7 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg once daily tablet (QD) orally.
|
1B-esc-160/480/1
n=6 Participants
Participants with Advanced Malignant Tumor were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2A-SCCHN IO Naive-160/480/100
n=44 Participants
Participants with immuno-oncology (IO)-naive second-line advanced or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2A-MEL 1L-160/480/100
n=54 Participants
Participants with first-line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2B-NSCLC 1L-160/480/1
n=62 Participants
Participants with first line advanced or metastatic non-small cell lung cancer (NSCLC) were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2B-MEL 1L-160/480/1
n=45 Participants
Participants with first line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Hemoglobin Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Lymphocytes Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
9 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Lymphocytes Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Absolute Neutrophil Count Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Aspartate Aminotransferase Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Aspartate Aminotransferase Grade 4
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Alanine Aminotransferase Grade 3
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
14 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Alanine Aminotransferase Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Bilirubin Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Creatinine Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Hyponatremia Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Hyperkalemia Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Hyperkalemia Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Hypokalemia Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Hypokalemia Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Hypercalcemia Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Hypocalcemia Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Hypermagnesemia Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Hypoglycemia Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose (Day 1) and within 30 days of last dose of study therapy (up to approximately 69 months)Population: All treated participants
Adverse events are any unfavorable or unintended signs, symptoms, or diseases occurring in study participants during a clinical trial, regardless of whether they are related to the intervention. They include all-cause mortality, serious adverse events, and other events exceeding a set frequency threshold. Serious adverse events are a subset that result in significant outcomes such as death, life-threatening conditions, hospitalization or its prolongation, persistent or significant disability/incapacity, or other medically important conditions.
Outcome measures
| Measure |
1A-esc-480/160/25
n=3 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 25 mg once daily tablet (QD) orally.
|
1A-esc-480/160/50
n=3 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 50 mg once daily tablet (QD) orally.
|
1A-esc-480/160/100
n=7 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg once daily tablet (QD) orally.
|
1B-esc-160/480/1
n=6 Participants
Participants with Advanced Malignant Tumor were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2A-SCCHN IO Naive-160/480/100
n=45 Participants
Participants with immuno-oncology (IO)-naive second-line advanced or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2A-MEL 1L-160/480/100
n=54 Participants
Participants with first-line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2B-NSCLC 1L-160/480/1
n=65 Participants
Participants with first line advanced or metastatic non-small cell lung cancer (NSCLC) were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2B-MEL 1L-160/480/1
n=46 Participants
Participants with first line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events and Deaths
Treatment Related Adverse Events
|
3 Participants
|
3 Participants
|
7 Participants
|
6 Participants
|
44 Participants
|
54 Participants
|
65 Participants
|
46 Participants
|
|
Number of Participants With Adverse Events and Deaths
Serious Adverse Events
|
1 Participants
|
1 Participants
|
6 Participants
|
4 Participants
|
29 Participants
|
21 Participants
|
38 Participants
|
27 Participants
|
|
Number of Participants With Adverse Events and Deaths
Adverse Events Leading to Discontinuation
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
15 Participants
|
19 Participants
|
23 Participants
|
22 Participants
|
|
Number of Participants With Adverse Events and Deaths
Deaths
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
7 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From first dose (Day 1) and up to 42 days post first dosePopulation: All Dose Limiting Toxicities evaluable population included in the analysis. Pre-specified to be collected for only Part 1A and 1B.
Dose-Limiting Toxicities (DLTs) are treatment-related adverse events occurring during the first cycle (typically Days 1-28) that meet predefined severity criteria per NCI CTCAE v4.03. Hematologic DLTs include Grade 4 neutropenia \>5 days, Grade 3 neutropenia with fever, Grade 4 thrombocytopenia or Grade 3 with bleeding, and Grade 4 anemia. Non-hematologic DLTs include any toxicity ≥Grade 3 (except alopecia or controlled nausea) or treatment interruption ≥2 weeks due to adverse events.
Outcome measures
| Measure |
1A-esc-480/160/25
n=2 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 25 mg once daily tablet (QD) orally.
|
1A-esc-480/160/50
n=3 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 50 mg once daily tablet (QD) orally.
|
1A-esc-480/160/100
n=6 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg once daily tablet (QD) orally.
|
1B-esc-160/480/1
n=6 Participants
Participants with Advanced Malignant Tumor were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2A-SCCHN IO Naive-160/480/100
Participants with immuno-oncology (IO)-naive second-line advanced or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2A-MEL 1L-160/480/100
Participants with first-line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2B-NSCLC 1L-160/480/1
Participants with first line advanced or metastatic non-small cell lung cancer (NSCLC) were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2B-MEL 1L-160/480/1
Participants with first line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the date of first dose (Day 1) to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 80 months)Population: All treated participants. Part 1A was for dose finding and to assess initial safety. The efficacy analysis was pre-defined to be analyzed on combined arms in Part 1A.
Objective Response Rate (ORR) is the percentage of participants whose best overall response is Complete Response (CR) or Partial Response (PR) per RECIST v1.1. CR is the disappearance of all target lesions and reduction of pathological lymph nodes to \<10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions from baseline. ORR is calculated as: (Number of participants with CR or PR ÷ Total participants) × 100. Confidence intervals are typically estimated using the Clopper-Pearson method.
Outcome measures
| Measure |
1A-esc-480/160/25
n=13 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 25 mg once daily tablet (QD) orally.
|
1A-esc-480/160/50
n=6 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 50 mg once daily tablet (QD) orally.
|
1A-esc-480/160/100
n=45 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg once daily tablet (QD) orally.
|
1B-esc-160/480/1
n=54 Participants
Participants with Advanced Malignant Tumor were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2A-SCCHN IO Naive-160/480/100
n=65 Participants
Participants with immuno-oncology (IO)-naive second-line advanced or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2A-MEL 1L-160/480/100
n=46 Participants
Participants with first-line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2B-NSCLC 1L-160/480/1
Participants with first line advanced or metastatic non-small cell lung cancer (NSCLC) were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2B-MEL 1L-160/480/1
Participants with first line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
23.1 percentage of participants
Interval 5.0 to 53.8
|
0.0 percentage of participants
Interval 0.0 to 100.0
|
22.2 percentage of participants
Interval 11.2 to 37.1
|
42.6 percentage of participants
Interval 29.2 to 56.8
|
23.1 percentage of participants
Interval 13.5 to 35.2
|
58.7 percentage of participants
Interval 43.2 to 73.0
|
—
|
—
|
PRIMARY outcome
Timeframe: From the date of first dose (Day 1) to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 80 months)Population: All treated participants. Part 1A was for dose finding and to assess initial safety. The efficacy analysis was pre-defined to be analyzed on combined arms in Part 1A.
Disease Control Rate (DCR) is the percentage of participants whose Best Overall Response (BOR) is Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST v1.1. CR is the disappearance of all target lesions and reduction of any pathological lymph nodes to \<10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions from baseline. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum diameters while on study. DCR is calculated as: (Number of participants with CR, PR, or SD ÷ Total participants) × 100.
Outcome measures
| Measure |
1A-esc-480/160/25
n=13 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 25 mg once daily tablet (QD) orally.
|
1A-esc-480/160/50
n=6 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 50 mg once daily tablet (QD) orally.
|
1A-esc-480/160/100
n=45 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg once daily tablet (QD) orally.
|
1B-esc-160/480/1
n=54 Participants
Participants with Advanced Malignant Tumor were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2A-SCCHN IO Naive-160/480/100
n=65 Participants
Participants with immuno-oncology (IO)-naive second-line advanced or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2A-MEL 1L-160/480/100
n=46 Participants
Participants with first-line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2B-NSCLC 1L-160/480/1
Participants with first line advanced or metastatic non-small cell lung cancer (NSCLC) were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2B-MEL 1L-160/480/1
Participants with first line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
46.2 percentage of participants
Interval 19.2 to 74.9
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
40.0 percentage of participants
Interval 25.7 to 55.7
|
59.3 percentage of participants
Interval 45.0 to 72.4
|
61.5 percentage of participants
Interval 48.6 to 73.3
|
76.1 percentage of participants
Interval 61.2 to 87.4
|
—
|
—
|
PRIMARY outcome
Timeframe: From the date of first dose (Day 1) to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 80 months)Population: All treated participants with response (CR or PR). Part 1A was for dose finding and to assess initial safety. The efficacy analysis was pre-defined to be analyzed on combined arms in Part 1A.
Duration of Response (mDOR) is the median time from the first documented occurrence of Complete Response (CR) or Partial Response (PR) until disease progression or death, assessed per RECIST v1.1. CR is the disappearance of all target lesions and reduction of pathological lymph nodes to \<10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions from baseline. Progression is defined as at least a 20% increase in the sum of diameters of target lesions or appearance of new lesions.
Outcome measures
| Measure |
1A-esc-480/160/25
n=3 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 25 mg once daily tablet (QD) orally.
|
1A-esc-480/160/50
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 50 mg once daily tablet (QD) orally.
|
1A-esc-480/160/100
n=10 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg once daily tablet (QD) orally.
|
1B-esc-160/480/1
n=23 Participants
Participants with Advanced Malignant Tumor were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2A-SCCHN IO Naive-160/480/100
n=15 Participants
Participants with immuno-oncology (IO)-naive second-line advanced or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2A-MEL 1L-160/480/100
n=27 Participants
Participants with first-line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2B-NSCLC 1L-160/480/1
Participants with first line advanced or metastatic non-small cell lung cancer (NSCLC) were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2B-MEL 1L-160/480/1
Participants with first line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR)
|
NA months
DoR not reached due to insufficient number of responders
|
—
|
18.50 months
Interval 6.83 to
DoR not reached due to insufficient number of responders
|
NA months
Interval 21.09 to
DoR not reached due to insufficient number of responders
|
21.88 months
Interval 5.55 to 28.25
|
NA months
DoR not reached due to insufficient number of responders
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of first dose (Day 1) to up to the date of the first documented disease progression or death (up to approximately 80 months)Population: All treated participants. Part 1A was for dose finding and to assess initial safety. The efficacy analysis was pre-defined to be analyzed on combined arms in Part 1A.
Progression-Free Survival (PFS) is the time from randomization or treatment start until the first documented disease progression or death from any cause, whichever occurs first, assessed per RECIST v1.1. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions (minimum 5 mm absolute increase) or appearance of new lesions. Participants without progression or death are censored at the date of last adequate tumor assessment. PFS is typically analyzed using Kaplan-Meier estimates and reported in months.
Outcome measures
| Measure |
1A-esc-480/160/25
n=13 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 25 mg once daily tablet (QD) orally.
|
1A-esc-480/160/50
n=6 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 50 mg once daily tablet (QD) orally.
|
1A-esc-480/160/100
n=45 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg once daily tablet (QD) orally.
|
1B-esc-160/480/1
n=54 Participants
Participants with Advanced Malignant Tumor were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2A-SCCHN IO Naive-160/480/100
n=65 Participants
Participants with immuno-oncology (IO)-naive second-line advanced or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2A-MEL 1L-160/480/100
n=46 Participants
Participants with first-line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2B-NSCLC 1L-160/480/1
Participants with first line advanced or metastatic non-small cell lung cancer (NSCLC) were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2B-MEL 1L-160/480/1
Participants with first line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
2.30 months
Interval 1.84 to 36.93
|
2.45 months
Interval 1.64 to
Not estimated due to inadequate number of event
|
1.87 months
Interval 1.74 to 3.58
|
4.44 months
Interval 1.87 to 23.06
|
3.81 months
Interval 2.53 to 7.1
|
NA months
Interval 3.94 to
Not estimated due to inadequate number of events
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 6 and 12Population: All treated participants. Part 1A was for dose finding and to assess initial safety. The efficacy analysis was pre-defined to be analyzed on combined arms in Part 1A.
Progression-Free Survival Rate (PFSR) is the percentage of participants who remain alive without disease progression, assessed per RECIST v1.1. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions (minimum 5 mm absolute increase) or appearance of new lesions. Participants without progression or death by the time point are considered event-free
Outcome measures
| Measure |
1A-esc-480/160/25
n=13 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 25 mg once daily tablet (QD) orally.
|
1A-esc-480/160/50
n=6 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 50 mg once daily tablet (QD) orally.
|
1A-esc-480/160/100
n=45 Participants
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg once daily tablet (QD) orally.
|
1B-esc-160/480/1
n=54 Participants
Participants with Advanced Malignant Tumor were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2A-SCCHN IO Naive-160/480/100
n=65 Participants
Participants with immuno-oncology (IO)-naive second-line advanced or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2A-MEL 1L-160/480/100
n=46 Participants
Participants with first-line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2B-NSCLC 1L-160/480/1
Participants with first line advanced or metastatic non-small cell lung cancer (NSCLC) were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2B-MEL 1L-160/480/1
Participants with first line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival Rate at 6 and 12 Months
12-month
|
30.8 percentage of participants
Interval 9.5 to 55.4
|
0.0 percentage of participants
Not estimated due to inadequate number of event
|
17.6 percentage of participants
Interval 7.6 to 31.0
|
40.1 percentage of participants
Interval 26.8 to 53.1
|
26.1 percentage of participants
Interval 15.5 to 37.9
|
62.4 percentage of participants
Interval 46.0 to 75.0
|
—
|
—
|
|
Progression Free Survival Rate at 6 and 12 Months
6-month
|
30.8 percentage of participants
Interval 9.5 to 55.4
|
33.3 percentage of participants
Interval 4.6 to 67.6
|
26.0 percentage of participants
Interval 13.8 to 40.0
|
46.2 percentage of participants
Interval 32.2 to 59.0
|
40.9 percentage of participants
Interval 28.5 to 53.0
|
62.4 percentage of participants
Interval 46.0 to 75.0
|
—
|
—
|
Adverse Events
1A-esc-480/160/25
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
1A-esc-480/160/50
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
1A-esc-480/160/100
Serious events: 6 serious events
Other events: 7 other events
Deaths: 5 deaths
1B-esc-160/480/1
Serious events: 4 serious events
Other events: 6 other events
Deaths: 3 deaths
2A-SCCHN IO Naive-160/480/100
Serious events: 29 serious events
Other events: 36 other events
Deaths: 35 deaths
2A-MEL 1L-160/480/100
Serious events: 21 serious events
Other events: 52 other events
Deaths: 21 deaths
2B-NSCLC 1L-160/480/1
Serious events: 38 serious events
Other events: 63 other events
Deaths: 46 deaths
2B-MEL 1L-160/480/1
Serious events: 27 serious events
Other events: 43 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
1A-esc-480/160/25
n=3 participants at risk
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 25 mg once daily tablet (QD) orally.
|
1A-esc-480/160/50
n=3 participants at risk
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 50 mg once daily tablet (QD) orally.
|
1A-esc-480/160/100
n=7 participants at risk
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg once daily tablet (QD) orally.
|
1B-esc-160/480/1
n=6 participants at risk
Participants with Advanced Malignant Tumor were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2A-SCCHN IO Naive-160/480/100
n=45 participants at risk
Participants with immuno-oncology (IO)-naive second-line advanced or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2A-MEL 1L-160/480/100
n=54 participants at risk
Participants with first-line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2B-NSCLC 1L-160/480/1
n=65 participants at risk
Participants with first line advanced or metastatic non-small cell lung cancer (NSCLC) were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2B-MEL 1L-160/480/1
n=46 participants at risk
Participants with first line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Endocrine disorders
Glucocorticoid deficiency
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Endocrine disorders
Lymphocytic hypophysitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.6%
3/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
8.7%
4/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.6%
3/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Megacolon
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
General disorders
Asthenia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
General disorders
Hyperthermia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
General disorders
Pain
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
General disorders
Pyrexia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Hepatobiliary disorders
Hepatic haematoma
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Hepatobiliary disorders
Hepatic vein thrombosis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Laryngopharyngitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Localised infection
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.6%
3/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
8.9%
4/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
9.2%
6/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Viral myocarditis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
General physical condition abnormal
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Troponin C increased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Troponin T increased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Troponin increased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.5%
3/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
28.6%
2/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.7%
3/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.6%
3/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.5%
3/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.7%
3/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour obstruction
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Nervous system disorders
Immune-mediated neuropathy
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Nervous system disorders
Neurological decompensation
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Product Issues
Device leakage
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Skin and subcutaneous tissue disorders
Superficial inflammatory dermatosis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
Other adverse events
| Measure |
1A-esc-480/160/25
n=3 participants at risk
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 25 mg once daily tablet (QD) orally.
|
1A-esc-480/160/50
n=3 participants at risk
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 50 mg once daily tablet (QD) orally.
|
1A-esc-480/160/100
n=7 participants at risk
Participants with Advanced Malignant Tumors were administered with Relatlimab 160 mg once in 4 weeks (Q4W), Nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg once daily tablet (QD) orally.
|
1B-esc-160/480/1
n=6 participants at risk
Participants with Advanced Malignant Tumor were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2A-SCCHN IO Naive-160/480/100
n=45 participants at risk
Participants with immuno-oncology (IO)-naive second-line advanced or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2A-MEL 1L-160/480/100
n=54 participants at risk
Participants with first-line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, nivolumab 480 mg Q4W as intravenous infusion and BMS-986205 100 mg QD tablet orally.
|
2B-NSCLC 1L-160/480/1
n=65 participants at risk
Participants with first line advanced or metastatic non-small cell lung cancer (NSCLC) were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
2B-MEL 1L-160/480/1
n=46 participants at risk
Participants with first line advanced or metastatic melanoma were administered with Relatlimab 160 mg Q4W, Nivolumab 480 mg Q4W and Ipilimumab 1 mg/kg once in 8 weeks (Q8W) as intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.6%
3/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
28.6%
2/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
11.1%
5/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.4%
4/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
12.3%
8/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
10.9%
5/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
General disorders
Asthenia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
37.8%
17/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
20.4%
11/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
40.0%
26/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
28.3%
13/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
General disorders
Chills
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
2/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.7%
5/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.5%
3/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
General disorders
Fatigue
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
28.6%
2/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
50.0%
3/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
13.3%
6/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.8%
8/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
32.3%
21/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
32.6%
15/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
13.0%
6/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.7%
5/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
9.2%
6/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
General disorders
Pain
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.6%
3/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.5%
3/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
2/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.2%
4/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
General disorders
Pyrexia
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
2/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
9.3%
5/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
29.2%
19/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
30.4%
14/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.5%
3/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
10.8%
7/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
2/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
5.6%
3/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.4%
4/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.7%
5/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Conjunctivitis
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Fungal infection
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
13.0%
7/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Oral candidiasis
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Otitis media
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
12.3%
8/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Pneumonia aspiration
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Post-acute COVID-19 syndrome
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.2%
4/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
5.6%
3/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
2/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.6%
3/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.7%
5/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
8.7%
4/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
28.6%
2/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.7%
5/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
10.9%
5/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
13.3%
6/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
51.9%
28/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.9%
11/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
17.4%
8/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Amylase increased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.8%
8/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
13.8%
9/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
15.2%
7/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
13.3%
6/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
48.1%
26/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.9%
11/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
19.6%
9/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.4%
4/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.8%
8/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.7%
5/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
5.6%
3/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
9.3%
5/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.5%
3/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.7%
3/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.4%
4/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
12.3%
8/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
5.6%
3/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
9.3%
5/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
11.1%
6/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.6%
3/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
22.2%
12/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.5%
3/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Lipase increased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
22.2%
12/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
12.3%
8/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
23.9%
11/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
9.3%
5/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Neutrophil count increased
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.4%
4/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Troponin increased
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
10.8%
7/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.5%
3/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Investigations
Weight decreased
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.4%
4/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
9.2%
6/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
13.0%
6/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Cell death
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
5.6%
3/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
28.6%
2/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
2/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
15.6%
7/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
22.2%
12/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
24.6%
16/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
15.2%
7/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
2/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
11.1%
5/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
8.7%
4/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.7%
3/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
9.3%
5/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
5.6%
3/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.6%
3/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.5%
3/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
9.3%
5/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.7%
5/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
11.1%
6/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
5.6%
3/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
5.6%
3/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
11.1%
6/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
2/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.4%
4/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
18.5%
12/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
23.9%
11/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.2%
4/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
10.8%
7/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
15.2%
7/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
5.6%
3/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.2%
4/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
9.3%
5/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.2%
4/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
10.9%
5/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
5.6%
3/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.4%
4/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
8.7%
4/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
2/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.7%
3/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.8%
8/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.2%
4/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
28.3%
13/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
5.6%
3/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.7%
5/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
9.3%
5/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.6%
3/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
13.0%
6/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
5.6%
3/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
5.6%
3/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.4%
4/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.4%
4/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
18.5%
12/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
23.9%
11/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
13.0%
7/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
27.7%
18/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
8.7%
4/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.5%
3/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.2%
4/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.2%
4/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.6%
3/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.5%
3/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
5.6%
3/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
8.9%
4/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
5.6%
3/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
24.6%
16/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
37.0%
17/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
57.1%
4/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
11.1%
6/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.9%
11/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
21.7%
10/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
11.1%
6/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.6%
3/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
10.9%
5/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
13.0%
6/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.5%
3/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
21.7%
10/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.7%
5/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
8.7%
4/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
26.7%
12/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
18.5%
10/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
13.8%
9/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
8.7%
4/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.2%
4/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.7%
3/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.8%
8/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Cardiac disorders
Angina pectoris
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Cardiac disorders
Palpitations
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
5.6%
3/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.5%
3/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Endocrine disorders
Glucocorticoid deficiency
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
5.6%
3/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
11.1%
6/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
24.6%
16/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
17.4%
8/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
5.6%
3/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.6%
3/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
13.3%
6/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
11.1%
6/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
26.2%
17/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
23.9%
11/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Endocrine disorders
Lymphocytic hypophysitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.3%
2/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.5%
3/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.7%
3/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.4%
4/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
7.7%
5/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
21.7%
10/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
11.1%
6/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.7%
2/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
3.1%
2/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
15.2%
7/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
2/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
13.3%
6/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
20.4%
11/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
10.8%
7/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
23.9%
11/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
2/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
11.1%
5/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.8%
8/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
35.4%
23/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
41.3%
19/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
50.0%
3/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
6.7%
3/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
5.6%
3/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
12.3%
8/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
17.4%
8/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.9%
1/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
1.5%
1/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
14.3%
1/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
10.9%
5/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.6%
3/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
8.7%
4/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
16.7%
1/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
2.2%
1/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
0.00%
0/3 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
28.6%
2/7 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
50.0%
3/6 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
4.4%
2/45 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
31.5%
17/54 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
21.5%
14/65 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
23.9%
11/46 • SAEs and Non-SAEs were collected from first dose (Day 1) and within 100 days of last dose of study therapy (up to approximately 71 months). All cause mortality was collected from first dose and up to approximately 80 months.
All treated population
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
- Publication restrictions are in place
Restriction type: OTHER