Trial Outcomes & Findings for Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors (NCT NCT03386721)
NCT ID: NCT03386721
Last Updated: 2023-02-21
Results Overview
ORR was defined as the percentage of participants with observed tumor response of complete response (CR), or partial response (PR) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The percentages of participants are rounded off to the nearest single decimal point.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
256 participants
Primary outcome timeframe
Baseline up to disease progression or study treatment discontinuation (up to 38 months)
Results posted on
2023-02-21
Participant Flow
Participants took part in the study at 42 investigative sites in Belgium, France, Germany, Israel, Korea, New Zealand, Poland, Russia, Singapore, Spain, Switzerland, Taiwan, Turkey, United Kingdom, USA from 19 February 2018 to 30 December 2021
A total of 256 participants were enrolled. 95 participants in non-small cell lung cancer (NCSLC) cohorts \[Part I: A, B, D, F \& Part II: E\] \& 161 participants in squamous cell carcinoma (SCC) cohort (78 with head and neck SCC (HNSCC) \[Part III: G, H, K\], 35 in esophageal SCC (ESCC) \[Part 3: I and M\], \& 48 in cervical SCC (CSCC) \[Part 3 J \& N\] received simlukafusp alfa \& atezolizumab. No participants were enrolled in Cohorts C \& L as emerging data did not lead to the need to open these cohorts.
Participant milestones
| Measure |
NSCLC: Part I Cohort A (QW/Q2W)
Checkpoint Inhibitor (CPI)-naïve participants with NSCLC, received simlukafusp alfa, 10 milligrams (mg), intravenous (IV) infusion, once weekly (QW) for the first 4 weeks, and every 2 weeks (Q2W) until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
|
NSCLC: Part I Cohort B (QW/Q2W)
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
|
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
|
NSCLC: Part I Cohort D, Arm 2 (Q3W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion once in 3 weeks (Q3W) in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
|
NSCLC: Part I Cohort D, Arm 3 (Q3W)
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
|
NSCLC: Part I Cohort F (Q3W)
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
|
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
NSCLC participants without prior treatment for metastatic disease and with high programmed death-ligand 1 (PD-L1) expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
|
NSCLC: Part II Cohort E, Arm 2 (Q3W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
|
SCCHN: Part III Cohort G (Q3W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
|
SCCHN: Part III Cohort H (Q3W)
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
|
ESCC: Part III Cohort I (Q3W)
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
|
CSCC: Part III Cohort J (Q3W)
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
|
SCCHN: Part III Cohort K (QW/Q2W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
|
ESCC: Part III Cohort M (QW/Q2W)
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
|
CSCC: Part III Cohort N (QW/Q2W)
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
32
|
3
|
5
|
2
|
22
|
3
|
2
|
23
|
30
|
33
|
47
|
25
|
2
|
1
|
|
Overall Study
Response Evaluable Population
|
26
|
32
|
3
|
5
|
0
|
21
|
3
|
2
|
22
|
28
|
32
|
44
|
25
|
2
|
1
|
|
Overall Study
COMPLETED
|
4
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
2
|
6
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
22
|
31
|
3
|
5
|
2
|
21
|
3
|
2
|
22
|
30
|
31
|
41
|
25
|
2
|
1
|
Reasons for withdrawal
| Measure |
NSCLC: Part I Cohort A (QW/Q2W)
Checkpoint Inhibitor (CPI)-naïve participants with NSCLC, received simlukafusp alfa, 10 milligrams (mg), intravenous (IV) infusion, once weekly (QW) for the first 4 weeks, and every 2 weeks (Q2W) until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
|
NSCLC: Part I Cohort B (QW/Q2W)
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
|
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
|
NSCLC: Part I Cohort D, Arm 2 (Q3W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion once in 3 weeks (Q3W) in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
|
NSCLC: Part I Cohort D, Arm 3 (Q3W)
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
|
NSCLC: Part I Cohort F (Q3W)
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
|
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
NSCLC participants without prior treatment for metastatic disease and with high programmed death-ligand 1 (PD-L1) expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
|
NSCLC: Part II Cohort E, Arm 2 (Q3W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
|
SCCHN: Part III Cohort G (Q3W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
|
SCCHN: Part III Cohort H (Q3W)
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
|
ESCC: Part III Cohort I (Q3W)
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
|
CSCC: Part III Cohort J (Q3W)
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
|
SCCHN: Part III Cohort K (QW/Q2W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
|
ESCC: Part III Cohort M (QW/Q2W)
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
|
CSCC: Part III Cohort N (QW/Q2W)
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
12
|
21
|
2
|
5
|
1
|
12
|
1
|
1
|
12
|
20
|
21
|
21
|
14
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
0
|
0
|
0
|
2
|
1
|
0
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Reason not specified
|
3
|
0
|
0
|
0
|
0
|
3
|
1
|
0
|
0
|
1
|
2
|
6
|
1
|
0
|
0
|
|
Overall Study
Progressive Disease
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
2
|
1
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Site Terminated by Sponsor
|
5
|
5
|
0
|
0
|
1
|
3
|
0
|
1
|
4
|
5
|
3
|
11
|
6
|
0
|
0
|
|
Overall Study
Symptomatic Deterioration
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
3
|
2
|
3
|
0
|
0
|
Baseline Characteristics
Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors
Baseline characteristics by cohort
| Measure |
NSCLC: Part I Cohort A (QW/Q2W)
n=26 Participants
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
|
NSCLC: Part I Cohort B (QW/Q2W)
n=32 Participants
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
|
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
n=3 Participants
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
|
NSCLC: Part I Cohort D, Arm 2 (Q3W)
n=5 Participants
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
|
NSCLC: Part I Cohort D, Arm 3 (Q3W)
n=2 Participants
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
|
NSCLC: Part I Cohort F (Q3W)
n=22 Participants
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
|
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
n=3 Participants
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
|
NSCLC: Part II Cohort E, Arm 2 (Q3W)
n=2 Participants
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
|
SCCHN: Part III Cohort G (Q3W)
n=23 Participants
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
|
SCCHN: Part III Cohort H (Q3W)
n=30 Participants
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
|
ESCC: Part III Cohort I (Q3W)
n=33 Participants
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
|
CSCC: Part III Cohort J (Q3W)
n=47 Participants
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
|
SCCHN: Part III Cohort K (QW/Q2W)
n=25 Participants
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
|
ESCC: Part III Cohort M (QW/Q2W)
n=2 Participants
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
|
CSCC: Part III Cohort N (QW/Q2W)
n=1 Participants
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
|
Total
n=256 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
63.7 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
65.6 years
STANDARD_DEVIATION 4.3 • n=4 Participants
|
63.5 years
STANDARD_DEVIATION 4.9 • n=21 Participants
|
57.4 years
STANDARD_DEVIATION 8.9 • n=8 Participants
|
56.7 years
STANDARD_DEVIATION 0.6 • n=8 Participants
|
68.0 years
STANDARD_DEVIATION 2.8 • n=24 Participants
|
55.7 years
STANDARD_DEVIATION 12.8 • n=42 Participants
|
58.8 years
STANDARD_DEVIATION 8.2 • n=42 Participants
|
63.1 years
STANDARD_DEVIATION 9.6 • n=42 Participants
|
51.3 years
STANDARD_DEVIATION 11.2 • n=42 Participants
|
55.8 years
STANDARD_DEVIATION 11.7 • n=36 Participants
|
67.0 years
STANDARD_DEVIATION 15.6 • n=36 Participants
|
49.0 years
STANDARD_DEVIATION NA • n=24 Participants
|
57.6 years
STANDARD_DEVIATION 10.8 • n=135 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
47 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
110 Participants
n=135 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
19 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
146 Participants
n=135 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
40 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
33 Participants
n=42 Participants
|
18 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
181 Participants
n=135 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
29 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
22 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
33 Participants
n=42 Participants
|
23 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
213 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Not Stated
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
29 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
11 Participants
n=135 Participants
|
PRIMARY outcome
Timeframe: Baseline up to disease progression or study treatment discontinuation (up to 38 months)Population: Response evaluable population included all participants in the safety population who received at least one dose of simlukafusp alfa/atezolizumab and who had at least one baseline and one on-study tumor assessment.
ORR was defined as the percentage of participants with observed tumor response of complete response (CR), or partial response (PR) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The percentages of participants are rounded off to the nearest single decimal point.
Outcome measures
| Measure |
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
n=3 Participants
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
|
NSCLC: Part I Cohort A (QW/Q2W)
n=26 Participants
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
|
NSCLC: Part I Cohort B (QW/Q2W)
n=32 Participants
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
|
NSCLC: Part I Cohort D, Arm 2 (Q3W)
n=5 Participants
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
|
NSCLC: Part I Cohort D, Arm 3 (Q3W)
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
|
NSCLC: Part I Cohort F (Q3W)
n=21 Participants
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
|
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
n=3 Participants
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
|
NSCLC: Part II Cohort E, Arm 2 (Q3W)
n=2 Participants
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
|
SCCHN: Part III Cohort G (Q3W)
n=22 Participants
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
|
SCCHN: Part III Cohort H (Q3W)
n=28 Participants
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
|
ESCC: Part III Cohort I (Q3W)
n=32 Participants
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
|
CSCC: Part III Cohort J (Q3W)
n=44 Participants
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
|
SCCHN: Part III Cohort K (QW/Q2W)
n=25 Participants
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
|
ESCC: Part III Cohort M (QW/Q2W)
n=2 Participants
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
|
CSCC: Part III Cohort N (QW/Q2W)
n=1 Participants
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
|
0 percentage of participants
Interval 0.0 to 56.15
|
19.2 percentage of participants
Interval 8.51 to 37.88
|
6.3 percentage of participants
Interval 1.73 to 20.15
|
0 percentage of participants
Interval 0.0 to 43.45
|
—
|
4.8 percentage of participants
Interval 0.85 to 22.67
|
66.7 percentage of participants
Interval 20.77 to 93.85
|
50.0 percentage of participants
Interval 9.45 to 90.55
|
18.2 percentage of participants
Interval 7.31 to 38.52
|
3.6 percentage of participants
Interval 0.63 to 17.71
|
21.9 percentage of participants
Interval 11.02 to 38.75
|
27.3 percentage of participants
Interval 16.35 to 41.85
|
4.0 percentage of participants
Interval 0.71 to 19.54
|
0 percentage of participants
Interval 0.0 to 65.76
|
0 percentage of participants
Interval 0.0 to 79.35
|
SECONDARY outcome
Timeframe: Baseline up to disease progression or study treatment discontinuation (up to 38 months)Population: Response evaluable population included all participants in the safety population who received at least one dose of simlukafusp alfa/atezolizumab and who had at least one baseline and one on-study tumor assessment.
DCR was defined as the percentage of participants with observed tumor response of CR, PR or stable disease (SD) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline (nadir). The percentages of participants are rounded off to the nearest single decimal point.
Outcome measures
| Measure |
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
n=3 Participants
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
|
NSCLC: Part I Cohort A (QW/Q2W)
n=26 Participants
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
|
NSCLC: Part I Cohort B (QW/Q2W)
n=32 Participants
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
|
NSCLC: Part I Cohort D, Arm 2 (Q3W)
n=5 Participants
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
|
NSCLC: Part I Cohort D, Arm 3 (Q3W)
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
|
NSCLC: Part I Cohort F (Q3W)
n=21 Participants
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
|
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
n=3 Participants
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
|
NSCLC: Part II Cohort E, Arm 2 (Q3W)
n=2 Participants
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
|
SCCHN: Part III Cohort G (Q3W)
n=22 Participants
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
|
SCCHN: Part III Cohort H (Q3W)
n=28 Participants
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
|
ESCC: Part III Cohort I (Q3W)
n=32 Participants
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
|
CSCC: Part III Cohort J (Q3W)
n=44 Participants
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
|
SCCHN: Part III Cohort K (QW/Q2W)
n=25 Participants
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
|
ESCC: Part III Cohort M (QW/Q2W)
n=2 Participants
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
|
CSCC: Part III Cohort N (QW/Q2W)
n=1 Participants
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Disease Control Rate (DCR) Determined According to RECIST Version 1.1
|
0 percentage of participants
Interval 0.0 to 56.15
|
53.8 percentage of participants
Interval 35.46 to 71.24
|
62.5 percentage of participants
Interval 45.25 to 77.07
|
20.0 percentage of participants
Interval 3.62 to 62.45
|
—
|
57.1 percentage of participants
Interval 36.55 to 75.53
|
66.7 percentage of participants
Interval 20.77 to 93.85
|
50.0 percentage of participants
Interval 9.45 to 90.55
|
50.0 percentage of participants
Interval 30.72 to 69.28
|
14.3 percentage of participants
Interval 5.7 to 31.49
|
43.8 percentage of participants
Interval 28.17 to 60.67
|
68.2 percentage of participants
Interval 53.44 to 80.0
|
36.0 percentage of participants
Interval 20.25 to 55.48
|
50.0 percentage of participants
Interval 9.45 to 90.55
|
0 percentage of participants
Interval 0.0 to 79.35
|
SECONDARY outcome
Timeframe: From first occurrence of documented CR or PR up to disease progression or study treatment discontinuation (assessed every 8 weeks after study treatment start for the first year, and every 12 weeks thereafter, up to 38 months)Population: Data was not collected for this outcome measure due to premature termination of the study by the sponsor.
DoR was determined for participants who had a best overall response of CR or PR. CR was defined as the disappearance of all target lesions with a reduction in target/non-target pathological lymph nodes to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DoR was defined as the time from first occurrence of a documented objective response until the time of documented disease progression or death from any cause during treatment, whichever occurs first. Participants that did not have documented progressive disease or death during the study were censored at the day of the last tumor assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study treatment initiation up to disease progression or study treatment discontinuation (up to 38 months)Population: Response evaluable population included all participants in the safety population who received at least one dose of simlukafusp alfa/atezolizumab and who had at least one baseline and one on-study tumor assessment.
PFS was defined as the time from study treatment initiation (Cycle 1 Day 1 \[1 cycle=14 days for QW/Q2W cohorts; 1 cycle=21 days for Q3W cohorts\]) to the first occurrence of documented disease progression (based on Investigator's assessment) or death from any cause during treatment, whichever occurs first. Participants that did not have documented progressive disease or death during the study were censored at the day of the last tumor assessment.
Outcome measures
| Measure |
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
n=3 Participants
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
|
NSCLC: Part I Cohort A (QW/Q2W)
n=26 Participants
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
|
NSCLC: Part I Cohort B (QW/Q2W)
n=32 Participants
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
|
NSCLC: Part I Cohort D, Arm 2 (Q3W)
n=5 Participants
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
|
NSCLC: Part I Cohort D, Arm 3 (Q3W)
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
|
NSCLC: Part I Cohort F (Q3W)
n=21 Participants
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
|
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
n=3 Participants
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
|
NSCLC: Part II Cohort E, Arm 2 (Q3W)
n=2 Participants
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
|
SCCHN: Part III Cohort G (Q3W)
n=22 Participants
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
|
SCCHN: Part III Cohort H (Q3W)
n=28 Participants
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
|
ESCC: Part III Cohort I (Q3W)
n=32 Participants
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
|
CSCC: Part III Cohort J (Q3W)
n=44 Participants
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
|
SCCHN: Part III Cohort K (QW/Q2W)
n=25 Participants
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
|
ESCC: Part III Cohort M (QW/Q2W)
n=2 Participants
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
|
CSCC: Part III Cohort N (QW/Q2W)
n=1 Participants
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) According to RECIST Version 1.1
|
2.0 months
Interval 1.7 to
Upper limit of 95% confidence interval (CI) could not be calculated due to low number of participants with events.
|
3.5 months
Interval 1.7 to 7.4
|
3.7 months
Interval 3.1 to 5.2
|
2.0 months
Interval 1.9 to
Upper limit of 95% CI could not be calculated due to low number of participants with events.
|
—
|
3.5 months
Interval 1.9 to 5.5
|
NA months
Interval 2.6 to
Median and Upper limit of 95% CI could not be calculated due to low number of participants with events.
|
10.5 months
Interval 1.9 to
Upper limit of 95% CI could not be calculated due to low number of participants with events.
|
2.5 months
Interval 1.8 to 5.6
|
1.9 months
Interval 1.8 to 1.9
|
1.9 months
Interval 1.8 to 3.7
|
3.7 months
Interval 3.3 to 9.0
|
1.9 months
Interval 1.6 to 3.2
|
2.6 months
Interval 1.6 to
Upper limit of 95% CI could not be calculated due to low number of participants with events.
|
1.9 months
Upper and lower limit of 95% CI could not be calculated as only one participant with events was evaluated.
|
SECONDARY outcome
Timeframe: From first dose of study treatment up to death due to any cause (up to approximately 47 months)Population: Response evaluable population included all participants in the safety population who received at least one dose of simlukafusp alfa/atezolizumab and who had at least one baseline and one on-study tumor assessment. Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
OS was defined as the time from the first dose of study treatment to the time of death from any cause on study. Participants who were still alive at the time of analysis were censored at the last date known alive.
Outcome measures
| Measure |
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
n=3 Participants
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
|
NSCLC: Part I Cohort A (QW/Q2W)
n=26 Participants
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
|
NSCLC: Part I Cohort B (QW/Q2W)
n=32 Participants
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
|
NSCLC: Part I Cohort D, Arm 2 (Q3W)
n=5 Participants
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
|
NSCLC: Part I Cohort D, Arm 3 (Q3W)
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
|
NSCLC: Part I Cohort F (Q3W)
n=21 Participants
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
|
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
n=3 Participants
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
|
NSCLC: Part II Cohort E, Arm 2 (Q3W)
n=2 Participants
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
|
SCCHN: Part III Cohort G (Q3W)
n=22 Participants
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
|
SCCHN: Part III Cohort H (Q3W)
n=28 Participants
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
|
ESCC: Part III Cohort I (Q3W)
n=32 Participants
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
|
CSCC: Part III Cohort J (Q3W)
n=44 Participants
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
|
SCCHN: Part III Cohort K (QW/Q2W)
n=25 Participants
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
|
ESCC: Part III Cohort M (QW/Q2W)
n=2 Participants
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
|
CSCC: Part III Cohort N (QW/Q2W)
n=1 Participants
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
NA months
Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
|
NA months
Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
|
NA months
Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
|
NA months
Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
|
—
|
NA months
Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
|
NA months
Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
|
NA months
Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
|
NA months
Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
|
NA months
Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
|
NA months
Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
|
NA months
Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
|
NA months
Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
|
NA months
Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
|
NA months
Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
|
SECONDARY outcome
Timeframe: Baseline up to end of the study (up to approximately 47 months)Population: Safety Population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
An AE is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
n=3 Participants
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
|
NSCLC: Part I Cohort A (QW/Q2W)
n=26 Participants
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
|
NSCLC: Part I Cohort B (QW/Q2W)
n=32 Participants
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
|
NSCLC: Part I Cohort D, Arm 2 (Q3W)
n=5 Participants
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
|
NSCLC: Part I Cohort D, Arm 3 (Q3W)
n=2 Participants
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
|
NSCLC: Part I Cohort F (Q3W)
n=22 Participants
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
|
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
n=3 Participants
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
|
NSCLC: Part II Cohort E, Arm 2 (Q3W)
n=2 Participants
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
|
SCCHN: Part III Cohort G (Q3W)
n=23 Participants
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
|
SCCHN: Part III Cohort H (Q3W)
n=30 Participants
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
|
ESCC: Part III Cohort I (Q3W)
n=33 Participants
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
|
CSCC: Part III Cohort J (Q3W)
n=47 Participants
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
|
SCCHN: Part III Cohort K (QW/Q2W)
n=25 Participants
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
|
ESCC: Part III Cohort M (QW/Q2W)
n=2 Participants
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
|
CSCC: Part III Cohort N (QW/Q2W)
n=1 Participants
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data was not collected for this outcome measure post-baseline as baseline data was not matured and sufficient to analyze PD-L1 impact.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up 2 monthsPopulation: Data was not collected for this outcome measure post-baseline as baseline data was not matured and sufficient to be analyzed during analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 2 monthsPopulation: Data was not collected for this outcome measure post-baseline as baseline data was not matured and sufficient to be analyzed during analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 2 monthsPopulation: Data was not collected for this outcome measure post-baseline as baseline data was not matured and sufficient to analyze PD-L1 impact.
Outcome measures
Outcome data not reported
Adverse Events
NSCLC: Part I Cohort A (QW/Q2W)
Serious events: 13 serious events
Other events: 25 other events
Deaths: 12 deaths
NSCLC: Part I Cohort B (QW/Q2W)
Serious events: 25 serious events
Other events: 32 other events
Deaths: 21 deaths
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
NSCLC: Part I Cohort D, Arm 2 (Q3W)
Serious events: 3 serious events
Other events: 5 other events
Deaths: 5 deaths
NSCLC: Part I Cohort D, Arm 3 (Q3W)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
NSCLC: Part I Cohort F (Q3W)
Serious events: 14 serious events
Other events: 21 other events
Deaths: 12 deaths
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
NSCLC: Part II Cohort E, Arm 2 (Q3W)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
SCCHN: Part III Cohort G (Q3W)
Serious events: 15 serious events
Other events: 23 other events
Deaths: 14 deaths
SCCHN: Part III Cohort H (Q3W)
Serious events: 22 serious events
Other events: 29 other events
Deaths: 20 deaths
ESCC: Part III Cohort I (Q3W)
Serious events: 20 serious events
Other events: 33 other events
Deaths: 21 deaths
CSCC: Part III Cohort J (Q3W)
Serious events: 32 serious events
Other events: 47 other events
Deaths: 21 deaths
SCCHN: Part III Cohort K (QW/Q2W)
Serious events: 14 serious events
Other events: 24 other events
Deaths: 14 deaths
ESCC: Part III Cohort M (QW/Q2W)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
CSCC: Part III Cohort N (QW/Q2W)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
NSCLC: Part I Cohort A (QW/Q2W)
n=26 participants at risk
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
|
NSCLC: Part I Cohort B (QW/Q2W)
n=32 participants at risk
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
|
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
n=3 participants at risk
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
|
NSCLC: Part I Cohort D, Arm 2 (Q3W)
n=5 participants at risk
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
|
NSCLC: Part I Cohort D, Arm 3 (Q3W)
n=2 participants at risk
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
|
NSCLC: Part I Cohort F (Q3W)
n=22 participants at risk
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
|
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
n=3 participants at risk
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
|
NSCLC: Part II Cohort E, Arm 2 (Q3W)
n=2 participants at risk
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
|
SCCHN: Part III Cohort G (Q3W)
n=23 participants at risk
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
|
SCCHN: Part III Cohort H (Q3W)
n=30 participants at risk
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
|
ESCC: Part III Cohort I (Q3W)
n=33 participants at risk
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
|
CSCC: Part III Cohort J (Q3W)
n=47 participants at risk
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
|
SCCHN: Part III Cohort K (QW/Q2W)
n=25 participants at risk
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
|
ESCC: Part III Cohort M (QW/Q2W)
n=2 participants at risk
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
|
CSCC: Part III Cohort N (QW/Q2W)
n=1 participants at risk
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
INFECTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Cardiac disorders
MYOCARDITIS
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Congenital, familial and genetic disorders
TRACHEO-OESOPHAGEAL FISTULA
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Endocrine disorders
ADDISON'S DISEASE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Endocrine disorders
IMMUNE-MEDIATED HYPOPHYSITIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
GASTRIC HAEMORRHAGE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
IMMUNE-MEDIATED ENTEROCOLITIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
LARGE INTESTINAL OBSTRUCTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
MOUTH HAEMORRHAGE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
OESOPHAGEAL FISTULA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
OESOPHAGEAL OBSTRUCTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
OESOPHAGEAL STENOSIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
PANCREATITIS
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
PROCTALGIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
CHILLS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
FACIAL PAIN
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
FATIGUE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
GENERALISED OEDEMA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
INFLAMMATION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
MALAISE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
MEDICAL DEVICE SITE HAEMORRHAGE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
OEDEMA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
PAIN
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
PERFORMANCE STATUS DECREASED
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
PYREXIA
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.5%
4/32 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
10.0%
3/30 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.5%
4/47 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Hepatobiliary disorders
BILE DUCT STENOSIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Hepatobiliary disorders
BILIARY OBSTRUCTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Hepatobiliary disorders
DRUG-INDUCED LIVER INJURY
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Hepatobiliary disorders
HEPATITIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Hepatobiliary disorders
HEPATOTOXICITY
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Immune system disorders
ANAPHYLACTIC SHOCK
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Immune system disorders
SYSTEMIC IMMUNE ACTIVATION
|
7.7%
2/26 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
ABDOMINAL WALL ABSCESS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
ASPERGILLUS INFECTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
BACTERAEMIA
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
BACTERIAL INFECTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
BRONCHITIS
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
CORNEAL INFECTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
COVID-19
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
ENCEPHALITIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
ESCHERICHIA INFECTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
LYMPH GLAND INFECTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
PELVIC INFECTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
PERITONEAL ABSCESS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
PLEURAL INFECTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.4%
3/32 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
2/22 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.7%
2/23 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
16.0%
4/25 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
PNEUMONIA NECROTISING
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
PULMONARY SEPSIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
2/22 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
VASCULAR DEVICE INFECTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
INCORRECT DOSE ADMINISTERED
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.4%
3/32 • Number of events 17 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
40.0%
2/5 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.7%
2/23 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
10.0%
3/30 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
14.9%
7/47 • Number of events 12 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
16.0%
4/25 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
MEDICATION ERROR
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
UROSTOMY COMPLICATION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
1/1 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
VASCULAR ACCESS COMPLICATION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
EJECTION FRACTION DECREASED
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
LIVER FUNCTION TEST INCREASED
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
3.8%
1/26 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
OXYGEN SATURATION DECREASED
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.7%
2/23 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.7%
2/23 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
TYPE 1 DIABETES MELLITUS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM PROGRESSION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR HAEMORRHAGE
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
AGNOSIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
APHASIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
NEURALGIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
POLYNEUROPATHY
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
SYNCOPE
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
VOCAL CORD PARALYSIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Product Issues
DEVICE DISLOCATION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
1/1 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
1/1 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.5%
4/47 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Renal and urinary disorders
NEPHRITIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Renal and urinary disorders
PYELOCALIECTASIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
1/1 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Reproductive system and breast disorders
FEMALE GENITAL TRACT FISTULA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL HAEMORRHAGE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL HAEMORRHAGE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
7.7%
2/26 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
STEVENS-JOHNSON SYNDROME
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Surgical and medical procedures
MEDICAL DEVICE REMOVAL
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Vascular disorders
CAPILLARY LEAK SYNDROME
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Vascular disorders
EMBOLISM
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Vascular disorders
HYPOTENSION
|
7.7%
2/26 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Vascular disorders
VASCULITIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
Other adverse events
| Measure |
NSCLC: Part I Cohort A (QW/Q2W)
n=26 participants at risk
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
|
NSCLC: Part I Cohort B (QW/Q2W)
n=32 participants at risk
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
|
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
n=3 participants at risk
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
|
NSCLC: Part I Cohort D, Arm 2 (Q3W)
n=5 participants at risk
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
|
NSCLC: Part I Cohort D, Arm 3 (Q3W)
n=2 participants at risk
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
|
NSCLC: Part I Cohort F (Q3W)
n=22 participants at risk
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
|
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
n=3 participants at risk
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
|
NSCLC: Part II Cohort E, Arm 2 (Q3W)
n=2 participants at risk
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
|
SCCHN: Part III Cohort G (Q3W)
n=23 participants at risk
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
|
SCCHN: Part III Cohort H (Q3W)
n=30 participants at risk
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
|
ESCC: Part III Cohort I (Q3W)
n=33 participants at risk
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
|
CSCC: Part III Cohort J (Q3W)
n=47 participants at risk
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
|
SCCHN: Part III Cohort K (QW/Q2W)
n=25 participants at risk
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
|
ESCC: Part III Cohort M (QW/Q2W)
n=2 participants at risk
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
|
CSCC: Part III Cohort N (QW/Q2W)
n=1 participants at risk
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
23.1%
6/26 • Number of events 15 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
18.8%
6/32 • Number of events 11 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
3/3 • Number of events 10 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
21.7%
5/23 • Number of events 10 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
18.2%
6/33 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
25.5%
12/47 • Number of events 14 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
24.0%
6/25 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
BLOOD CHOLESTEROL INCREASED
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
BLOOD CREATININE INCREASED
|
11.5%
3/26 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.5%
4/32 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
17.4%
4/23 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.8%
6/47 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.0%
3/25 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
11.5%
3/26 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
34.4%
11/32 • Number of events 18 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
22.7%
5/22 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
65.2%
15/23 • Number of events 29 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
30.0%
9/30 • Number of events 13 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
21.2%
7/33 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
48.9%
23/47 • Number of events 40 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
44.0%
11/25 • Number of events 29 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Blood and lymphatic system disorders
COAGULOPATHY
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.4%
3/47 • Number of events 11 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Blood and lymphatic system disorders
LYMPHOCYTOSIS
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.5%
4/32 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
17.4%
4/23 • Number of events 15 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
10.0%
3/30 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
3/33 • Number of events 17 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.8%
6/47 • Number of events 17 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
16.0%
4/25 • Number of events 25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
11.5%
3/26 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
3/33 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.8%
6/47 • Number of events 12 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.0%
3/25 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
2/22 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.8%
6/47 • Number of events 14 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Ear and labyrinth disorders
VERTIGO
|
7.7%
2/26 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Endocrine disorders
GLUCOCORTICOID DEFICIENCY
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
15.4%
4/26 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
3/3 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.5%
4/47 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
15.4%
4/26 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
17.4%
4/23 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
21.2%
7/33 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.4%
3/47 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
5/25 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
3.8%
1/26 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
21.3%
10/47 • Number of events 12 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
19.2%
5/26 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
CONSTIPATION
|
7.7%
2/26 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.4%
3/32 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
2/22 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
21.7%
5/23 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
13.3%
4/30 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
18.2%
6/33 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.8%
6/47 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
2/2 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
DIARRHOEA
|
34.6%
9/26 • Number of events 17 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
28.1%
9/32 • Number of events 10 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
66.7%
2/3 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
13.6%
3/22 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
13.0%
3/23 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
16.7%
5/30 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
21.2%
7/33 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
36.2%
17/47 • Number of events 29 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
16.0%
4/25 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.5%
4/47 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 12 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.0%
3/25 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
3.8%
1/26 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
NAUSEA
|
42.3%
11/26 • Number of events 22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
31.2%
10/32 • Number of events 11 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
36.4%
8/22 • Number of events 11 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
66.7%
2/3 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
26.1%
6/23 • Number of events 14 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
23.3%
7/30 • Number of events 11 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
39.4%
13/33 • Number of events 49 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
40.4%
19/47 • Number of events 46 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
44.0%
11/25 • Number of events 44 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
1/1 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
OESOPHAGEAL PAIN
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Gastrointestinal disorders
VOMITING
|
38.5%
10/26 • Number of events 24 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
21.9%
7/32 • Number of events 10 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
11/22 • Number of events 16 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
21.7%
5/23 • Number of events 19 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
16.7%
5/30 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
3/33 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
38.3%
18/47 • Number of events 45 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
1/1 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
ASTHENIA
|
23.1%
6/26 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
21.9%
7/32 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
66.7%
2/3 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
40.0%
2/5 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
31.8%
7/22 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
39.1%
9/23 • Number of events 10 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
40.0%
12/30 • Number of events 12 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
24.2%
8/33 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
48.9%
23/47 • Number of events 28 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
16.0%
4/25 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
CHEST PAIN
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
3/33 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
CHILLS
|
46.2%
12/26 • Number of events 23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
37.5%
12/32 • Number of events 23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
40.0%
2/5 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
40.9%
9/22 • Number of events 15 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
26.1%
6/23 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
10/30 • Number of events 10 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
36.4%
12/33 • Number of events 25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
25.5%
12/47 • Number of events 18 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
36.0%
9/25 • Number of events 49 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
2/2 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
1/1 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
FATIGUE
|
53.8%
14/26 • Number of events 25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
46.9%
15/32 • Number of events 21 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
13.6%
3/22 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
26.1%
6/23 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
16.7%
5/30 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
24.2%
8/33 • Number of events 11 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
19.1%
9/47 • Number of events 12 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
44.0%
11/25 • Number of events 19 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
1/1 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
HYPERTHERMIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.5%
4/47 • Number of events 23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
MALAISE
|
7.7%
2/26 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
MUCOSAL INFLAMMATION
|
7.7%
2/26 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.5%
4/47 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
OEDEMA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
OEDEMA PERIPHERAL
|
23.1%
6/26 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.5%
4/32 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
14.9%
7/47 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
PAIN
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
PYREXIA
|
76.9%
20/26 • Number of events 197 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
90.6%
29/32 • Number of events 91 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
3/3 • Number of events 11 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
5/5 • Number of events 11 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
68.2%
15/22 • Number of events 47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
66.7%
2/3 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
78.3%
18/23 • Number of events 76 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
73.3%
22/30 • Number of events 60 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
78.8%
26/33 • Number of events 116 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
74.5%
35/47 • Number of events 134 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
84.0%
21/25 • Number of events 110 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
2/2 • Number of events 13 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
1/1 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
General disorders
XEROSIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Hepatobiliary disorders
HEPATOTOXICITY
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.4%
3/47 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.7%
2/23 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.0%
3/25 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.7%
2/23 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
BRONCHITIS
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
CELLULITIS
|
7.7%
2/26 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
CONJUNCTIVITIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
NASOPHARYNGITIS
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
PNEUMONIA
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
2/22 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
3/33 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.4%
3/32 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
RHINITIS
|
7.7%
2/26 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
11.5%
3/26 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
40.0%
2/5 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
13.0%
3/23 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
16.0%
4/25 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.1%
4/33 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
29.8%
14/47 • Number of events 19 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
15.4%
4/26 • Number of events 11 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
21.9%
7/32 • Number of events 16 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
40.0%
2/5 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
2/22 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.7%
2/23 • Number of events 13 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
15.2%
5/33 • Number of events 23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
14.9%
7/47 • Number of events 16 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
5/25 • Number of events 24 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
34.6%
9/26 • Number of events 24 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
28.1%
9/32 • Number of events 12 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
13.6%
3/22 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
52.2%
12/23 • Number of events 21 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
6/30 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
42.4%
14/33 • Number of events 27 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
44.7%
21/47 • Number of events 49 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
36.0%
9/25 • Number of events 13 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
46.2%
12/26 • Number of events 27 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
25.0%
8/32 • Number of events 13 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
22.7%
5/22 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
69.6%
16/23 • Number of events 37 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
6/30 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
42.4%
14/33 • Number of events 25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
46.8%
22/47 • Number of events 56 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
44.0%
11/25 • Number of events 21 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
BILIRUBIN CONJUGATED INCREASED
|
7.7%
2/26 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.4%
3/47 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
15.4%
4/26 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.5%
4/32 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
2/22 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
30.4%
7/23 • Number of events 15 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
13.3%
4/30 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
15.2%
5/33 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
23.4%
11/47 • Number of events 18 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
32.0%
8/25 • Number of events 15 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.8%
6/47 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
16.0%
4/25 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
BLOOD URIC ACID INCREASED
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
EOSINOPHIL COUNT INCREASED
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
19.2%
5/26 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.5%
4/32 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
13.6%
3/22 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
52.2%
12/23 • Number of events 28 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
30.0%
9/30 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
15.2%
5/33 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
34.0%
16/47 • Number of events 25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
48.0%
12/25 • Number of events 17 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.5%
4/47 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
LIPASE INCREASED
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.4%
3/32 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
7.7%
2/26 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
13.0%
3/23 • Number of events 10 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
3/33 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
10.6%
5/47 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 16 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
7.7%
2/26 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
PLATELET COUNT DECREASED
|
7.7%
2/26 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
26.1%
6/23 • Number of events 24 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
10.6%
5/47 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
16.0%
4/25 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
TRANSAMINASES INCREASED
|
11.5%
3/26 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.4%
3/47 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
WEIGHT DECREASED
|
23.1%
6/26 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.7%
2/23 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
10.0%
3/30 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.0%
3/25 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
1/1 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
17.4%
4/23 • Number of events 10 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
26.9%
7/26 • Number of events 11 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
37.5%
12/32 • Number of events 16 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
66.7%
2/3 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
27.3%
6/22 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
66.7%
2/3 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
17.4%
4/23 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
36.7%
11/30 • Number of events 11 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
18.2%
6/33 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
25.5%
12/47 • Number of events 15 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.0%
3/25 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
21.7%
5/23 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
3/33 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.4%
3/47 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
HYPERNATRAEMIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.7%
2/23 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
13.0%
3/23 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
7.7%
2/26 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
2/22 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
21.7%
5/23 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.8%
6/47 • Number of events 10 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.5%
4/47 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
15.4%
4/26 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
13.6%
3/22 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.7%
2/23 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
10.0%
3/30 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
19.1%
9/47 • Number of events 11 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
11.5%
3/26 • Number of events 14 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.4%
3/32 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
66.7%
2/3 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
17.4%
4/23 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
13.3%
4/30 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
17.0%
8/47 • Number of events 13 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
34.8%
8/23 • Number of events 13 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
16.0%
4/25 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
19.2%
5/26 • Number of events 12 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.5%
4/32 • Number of events 15 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
2/22 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
21.7%
5/23 • Number of events 11 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
16.7%
5/30 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.1%
4/33 • Number of events 13 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
19.1%
9/47 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
5/25 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
15.4%
4/26 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
15.6%
5/32 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
15.2%
5/33 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
14.9%
7/47 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.0%
3/25 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
7.7%
2/26 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
26.9%
7/26 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
3/33 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
19.1%
9/47 • Number of events 10 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
1/1 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
3.8%
1/26 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
13.6%
3/22 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
17.4%
4/23 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.1%
4/33 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.0%
3/25 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
7.7%
2/26 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
14.9%
7/47 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.5%
4/32 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
3/33 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.4%
3/47 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
HEADACHE
|
15.4%
4/26 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.5%
4/32 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
66.7%
2/3 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.7%
2/23 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
21.2%
7/33 • Number of events 13 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
17.0%
8/47 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
16.0%
4/25 • Number of events 10 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
1/1 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.7%
2/23 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
NEUROTOXICITY
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
10.0%
3/30 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
10.6%
5/47 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Psychiatric disorders
INSOMNIA
|
15.4%
4/26 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
13.6%
3/22 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
13.0%
3/23 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
3/33 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
17.0%
8/47 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.5%
4/47 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.0%
3/25 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
100.0%
1/1 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.4%
3/47 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
15.4%
4/26 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
25.0%
8/32 • Number of events 11 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
66.7%
2/3 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
18.2%
4/22 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.7%
2/23 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.1%
4/33 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.8%
6/47 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
13.0%
3/23 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
23.1%
6/26 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
21.9%
7/32 • Number of events 10 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
13.6%
3/22 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.7%
2/23 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
10.0%
3/30 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.1%
4/33 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.8%
6/47 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
7.7%
2/26 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.4%
3/32 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
11.5%
3/26 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
9.1%
3/33 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
7.7%
2/26 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
2/47 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
7.7%
2/26 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.2%
2/32 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.0%
1/33 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.4%
3/47 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.4%
3/47 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.4%
3/47 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
23.1%
6/26 • Number of events 11 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
18.8%
6/32 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
66.7%
2/3 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
40.0%
2/5 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
31.8%
7/22 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.7%
2/30 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.1%
4/33 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
17.0%
8/47 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
28.0%
7/25 • Number of events 9 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
RASH
|
50.0%
13/26 • Number of events 26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
15.6%
5/32 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
33.3%
1/3 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
13.6%
3/22 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
66.7%
2/3 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
30.4%
7/23 • Number of events 12 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.1%
4/33 • Number of events 7 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
19.1%
9/47 • Number of events 15 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
16.0%
4/25 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
11.5%
3/26 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
66.7%
2/3 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
7.7%
2/26 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.4%
3/47 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Vascular disorders
CAPILLARY LEAK SYNDROME
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/47 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Vascular disorders
HYPERTENSION
|
3.8%
1/26 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.1%
1/32 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.5%
1/22 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
4.3%
1/23 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
3.3%
1/30 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
8.0%
2/25 • Number of events 4 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
50.0%
1/2 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Vascular disorders
HYPOTENSION
|
7.7%
2/26 • Number of events 2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
34.4%
11/32 • Number of events 14 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
27.3%
6/22 • Number of events 6 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
17.4%
4/23 • Number of events 5 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
26.7%
8/30 • Number of events 11 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
6.1%
2/33 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.8%
6/47 • Number of events 8 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
12.0%
3/25 • Number of events 3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
|
Vascular disorders
THROMBOSIS
|
0.00%
0/26 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/32 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
20.0%
1/5 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/22 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/3 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/23 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/30 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/33 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
2.1%
1/47 • Number of events 1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/25 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/2 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
0.00%
0/1 • Baseline up to end of the study (up to approximately 47 months)
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER