Trial Outcomes & Findings for Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Entospletinib in Adults With Relapsed or Refractory Hematologic Malignancies (NCT NCT01799889)
NCT ID: NCT01799889
Last Updated: 2020-11-19
Results Overview
PFS rate was assessed by Independent Review Committee (IRC) and defined per standardized criteria (2007 Cheson criteria) (for NHL) and International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria (for CLL), as the percentage of participants not experiencing definitive progression or death. Disease progression was defined per standardized criteria as: evidence of any new disease; worsening of nodal or extra-nodal index lesions; unequivocal increase in the size of non-index lesions or non-measurable disease, size of the liver, spleen, or other organ; and a ≥ 25% increase from nadir in either monoclonal immunoglobulin M (IgM) concentration or total serum IgM quantitation. Disease progression was defined per standardized IWCLL criteria as: evidence of any new disease; worsening of index lesions, spleen or liver, or non-index disease; and decrease in platelet count or hemoglobin that is attributable to CLL. PFS rate was analyzed using Kaplan-Meier (KM) estimates.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
326 participants
Primary outcome timeframe
Week 16
Results posted on
2020-11-19
Participant Flow
Participants were enrolled at study sites in United States and Canada. The first participant was screened on 14 March 2013. The last study visit occurred on 30 January 2020.
444 participants were screened.
Participant milestones
| Measure |
CLL: Entospletinib MM/SDD
Participants with chronic lymphocytic leukemia (CLL), received original formulation (mono-mesylate \[MM\]) of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib (spray dried dispersion \[SDD\]) 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
FL: Entospletinib MM/SDD
Participants with follicular lymphoma (FL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
DLBCL: Entospletinib MM/SDD
Participants with diffuse large B-cell lymphoma (DLBCL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
MCL: Entospletinib MM/SDD
Participants with mantle cell lymphoma (MCL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
Non-FL iNHL: Entospletinib MM/SDD
Participants with non-FL indolent non-Hodgkin lymphomas (iNHL), (ie, participants with lymphoplasmacytoid lymphoma/ waldenström macroglobulinemia \[LPL/WM\], small lymphocytic lymphoma \[SLL\], or marginal zone lymphoma \[MZL\]), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 100 mg
Participants with CLL, who were prior B-cell receptor (BCR) inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
Participants with CLL and simple progression (non-Richters), who were exposed to Bruton tyrosine kinase (BTK) inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
Participants with CLL and simple progression (non-Richters), who were exposed to phosphatidylinositol 3-kinase (PI3K) inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
44
|
39
|
49
|
20
|
21
|
20
|
33
|
8
|
7
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
41
|
41
|
44
|
39
|
49
|
20
|
21
|
20
|
33
|
8
|
7
|
3
|
Reasons for withdrawal
| Measure |
CLL: Entospletinib MM/SDD
Participants with chronic lymphocytic leukemia (CLL), received original formulation (mono-mesylate \[MM\]) of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib (spray dried dispersion \[SDD\]) 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
FL: Entospletinib MM/SDD
Participants with follicular lymphoma (FL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
DLBCL: Entospletinib MM/SDD
Participants with diffuse large B-cell lymphoma (DLBCL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
MCL: Entospletinib MM/SDD
Participants with mantle cell lymphoma (MCL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
Non-FL iNHL: Entospletinib MM/SDD
Participants with non-FL indolent non-Hodgkin lymphomas (iNHL), (ie, participants with lymphoplasmacytoid lymphoma/ waldenström macroglobulinemia \[LPL/WM\], small lymphocytic lymphoma \[SLL\], or marginal zone lymphoma \[MZL\]), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 100 mg
Participants with CLL, who were prior B-cell receptor (BCR) inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
Participants with CLL and simple progression (non-Richters), who were exposed to Bruton tyrosine kinase (BTK) inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
Participants with CLL and simple progression (non-Richters), who were exposed to phosphatidylinositol 3-kinase (PI3K) inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
4
|
5
|
1
|
11
|
1
|
5
|
2
|
3
|
1
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
5
|
3
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
0
|
1
|
2
|
2
|
0
|
0
|
2
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
3
|
2
|
4
|
4
|
5
|
5
|
5
|
2
|
6
|
0
|
0
|
1
|
|
Overall Study
Progressive Disease
|
30
|
26
|
25
|
30
|
23
|
9
|
8
|
13
|
18
|
5
|
3
|
1
|
|
Overall Study
Specified Criteria for Withdrawal
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Study Terminated By Sponsor
|
1
|
0
|
0
|
0
|
2
|
1
|
0
|
2
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
6
|
4
|
0
|
5
|
1
|
3
|
1
|
2
|
1
|
1
|
1
|
|
Overall Study
Non-Compliance With Study Drug
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Entospletinib in Adults With Relapsed or Refractory Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
CLL: Entospletinib MM/SDD
n=41 Participants
Participants with CLL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
FL: Entospletinib MM/SDD
n=41 Participants
Participants with FL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
DLBCL: Entospletinib MM/SDD
n=43 Participants
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
MCL: Entospletinib MM/SDD
n=39 Participants
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
Non-FL iNHL: Entospletinib MM/SDD
n=49 Participants
Participants with iNHL (ie, participants with LPL/WM, SLL, or MZL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 100 mg
n=19 Participants
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg
n=21 Participants
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg
n=20 Participants
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
n=33 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=8 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
n=6 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=3 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
Total
n=323 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 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
|
3 Participants
n=36 Participants
|
|
Age, Continuous
|
73 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
66 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
67 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
71 years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
70 years
STANDARD_DEVIATION 9.8 • n=21 Participants
|
69 years
STANDARD_DEVIATION 11.1 • n=10 Participants
|
72 years
STANDARD_DEVIATION 10.9 • n=115 Participants
|
69 years
STANDARD_DEVIATION 9.4 • n=24 Participants
|
71 years
STANDARD_DEVIATION 7.4 • n=42 Participants
|
61 years
STANDARD_DEVIATION 9.7 • n=42 Participants
|
70 years
STANDARD_DEVIATION 8.6 • n=42 Participants
|
73 years
STANDARD_DEVIATION 12.7 • n=42 Participants
|
70 years
STANDARD_DEVIATION 11.0 • n=36 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
121 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
13 Participants
n=24 Participants
|
24 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
202 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
16 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
18 Participants
n=24 Participants
|
30 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
298 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
9 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 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
|
3 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
19 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 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
|
1 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · White/Caucasian
|
37 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
17 Participants
n=24 Participants
|
27 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
291 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · Not Permitted
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
5 participants
n=21 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
0 participants
n=24 Participants
|
2 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
15 participants
n=36 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
41 participants
n=7 Participants
|
39 participants
n=5 Participants
|
36 participants
n=4 Participants
|
44 participants
n=21 Participants
|
19 participants
n=10 Participants
|
20 participants
n=115 Participants
|
20 participants
n=24 Participants
|
31 participants
n=42 Participants
|
8 participants
n=42 Participants
|
6 participants
n=42 Participants
|
3 participants
n=42 Participants
|
308 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: The Full Analysis Set included all enrolled participants who took at least one dose of study drug with treatment group designated according to the planned treatment. Only participants with CLL after BCR target therapy (including CLL non-Richters, and CLL Richters participants), SDD, MCL, and DLBCL were analyzed for this outcome measure.
PFS rate was assessed by Independent Review Committee (IRC) and defined per standardized criteria (2007 Cheson criteria) (for NHL) and International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria (for CLL), as the percentage of participants not experiencing definitive progression or death. Disease progression was defined per standardized criteria as: evidence of any new disease; worsening of nodal or extra-nodal index lesions; unequivocal increase in the size of non-index lesions or non-measurable disease, size of the liver, spleen, or other organ; and a ≥ 25% increase from nadir in either monoclonal immunoglobulin M (IgM) concentration or total serum IgM quantitation. Disease progression was defined per standardized IWCLL criteria as: evidence of any new disease; worsening of index lesions, spleen or liver, or non-index disease; and decrease in platelet count or hemoglobin that is attributable to CLL. PFS rate was analyzed using Kaplan-Meier (KM) estimates.
Outcome measures
| Measure |
DLBCL: Entospletinib MM/SDD
n=43 Participants
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
MCL: Entospletinib MM/SDD
n=39 Participants
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
n=33 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=8 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
n=6 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=3 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) Rate of Participants With CLL After BCR Targeted Therapy, MCL, and DLBCL at Week 16
|
3.6 percentage of participants
Interval 0.3 to 15.2
|
63.9 percentage of participants
Interval 45.0 to 77.8
|
64 percentage of participants
Interval 43.2 to 78.9
|
100 percentage of participants
Interval 100.0 to 100.0
|
20 percentage of participants
Interval 0.8 to 58.2
|
50 percentage of participants
Interval 0.6 to 91.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 24Population: Participants in the full analysis set were analyzed. Only participants with CLL (including CLL, prior BCR inhibitor naive participants), FL, and non-FL iNHL were analyzed for this outcome measure.
PFS rate was assessed by IRC and defined per standardized criteria (2007 Cheson criteria) (for NHL) and IWCLL criteria (for CLL), as the percentage of participants not experiencing definitive progression or death. Disease progression was defined per standardized criteria (2007 Cheson criteria) as: evidence of any new disease; worsening of nodal or extra-nodal index lesions; unequivocal increase in the size of non-index lesions or non-measurable disease, size of the liver, spleen, or other organ; and a ≥ 25% increase from nadir in either monoclonal IgM concentration or total serum IgM quantitation. Disease progression was defined per standardized IWCLL criteria as: evidence of any new disease; worsening of index lesions, spleen or liver, or non-index disease; and decrease in platelet count or hemoglobin that is attributable to CLL. PFS rate was analyzed using KM estimates.
Outcome measures
| Measure |
DLBCL: Entospletinib MM/SDD
n=41 Participants
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
MCL: Entospletinib MM/SDD
n=41 Participants
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
n=49 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=19 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
n=21 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=20 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PFS Rate of Participants With CLL (Including CLL, Prior BCR Inhibitor Naive Participants), FL, and Non-FL iNHL at Week 24
|
66.9 percentage of participants
Interval 48.0 to 80.2
|
51.5 percentage of participants
Interval 32.8 to 67.4
|
63.5 percentage of participants
Interval 45.3 to 77.1
|
64.2 percentage of participants
Interval 33.4 to 83.6
|
81.6 percentage of participants
Interval 51.6 to 93.9
|
84.2 percentage of participants
Interval 58.7 to 94.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First dose date up to the last dose date plus 30 days (maximum: 78.4 months)Population: The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
A treatment-emergent Adverse Event (AE) was defined as an AE that occurs in the period from the first dose of study treatment to 30 days after the last dose of study treatment or leads to discontinuation of study treatment. Participants were assessed for AEs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.
Outcome measures
| Measure |
DLBCL: Entospletinib MM/SDD
n=41 Participants
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
MCL: Entospletinib MM/SDD
n=41 Participants
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
n=43 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=39 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
n=49 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=19 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg
n=21 Participants
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg
n=20 Participants
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
n=33 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=8 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
n=6 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=3 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
|
100.0 percentage of participants
|
100.0 percentage of participants
|
97.7 percentage of participants
|
97.4 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
95.2 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to the last dose date plus 30 days (maximum: 78.4 months)Population: Participants in the Safety Analysis Set were analyzed.
Hematology toxicity at any time postbaseline was summarized according to the NCI CTCAE, version 4.03. The most severe graded abnormality was counted for each participant per test. ANC = absolute neutrophil count; Hb = hemoglobin; WBC = white blood cells
Outcome measures
| Measure |
DLBCL: Entospletinib MM/SDD
n=41 Participants
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
MCL: Entospletinib MM/SDD
n=41 Participants
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
n=43 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=39 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
n=49 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=19 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg
n=21 Participants
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg
n=20 Participants
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
n=33 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=8 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
n=6 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=3 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Grade 4 WBC Decrease
|
0 percentage of participants
|
0 percentage of participants
|
4.7 percentage of participants
|
2.6 percentage of participants
|
2.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Grade 3 Lymphocyte Count Decrease
|
0 percentage of participants
|
17.1 percentage of participants
|
48.8 percentage of participants
|
15.4 percentage of participants
|
22.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6.1 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Grade 4 Lymphocyte Count Decrease
|
2.4 percentage of participants
|
2.4 percentage of participants
|
9.3 percentage of participants
|
2.6 percentage of participants
|
6.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Grade 3 Lymphocyte Count Increase
|
85.4 percentage of participants
|
9.8 percentage of participants
|
0 percentage of participants
|
12.8 percentage of participants
|
6.1 percentage of participants
|
94.7 percentage of participants
|
85.7 percentage of participants
|
70.0 percentage of participants
|
63.6 percentage of participants
|
37.5 percentage of participants
|
33.3 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Grade 4 Lymphocyte Count Increase
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Grade 3 Neutrophils Decrease
|
14.6 percentage of participants
|
12.2 percentage of participants
|
2.3 percentage of participants
|
2.6 percentage of participants
|
10.2 percentage of participants
|
15.8 percentage of participants
|
9.5 percentage of participants
|
20.0 percentage of participants
|
12.1 percentage of participants
|
25.0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Grade 4 Neutrophils Decrease
|
19.5 percentage of participants
|
0 percentage of participants
|
2.3 percentage of participants
|
2.6 percentage of participants
|
12.2 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
20.0 percentage of participants
|
9.1 percentage of participants
|
12.5 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Grade 3 Platelet Count Decrease
|
7.3 percentage of participants
|
2.4 percentage of participants
|
2.3 percentage of participants
|
5.1 percentage of participants
|
6.1 percentage of participants
|
10.5 percentage of participants
|
4.8 percentage of participants
|
10.0 percentage of participants
|
15.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Grade 4 Platelet Count Decrease
|
7.3 percentage of participants
|
4.9 percentage of participants
|
0 percentage of participants
|
7.7 percentage of participants
|
4.1 percentage of participants
|
0 percentage of participants
|
4.8 percentage of participants
|
0 percentage of participants
|
9.1 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Grade 3 ANC Decrease
|
14.6 percentage of participants
|
12.2 percentage of participants
|
2.3 percentage of participants
|
2.6 percentage of participants
|
6.1 percentage of participants
|
15.8 percentage of participants
|
9.5 percentage of participants
|
25.0 percentage of participants
|
12.1 percentage of participants
|
25.0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Grade 4 ANC Decrease
|
22.0 percentage of participants
|
4.9 percentage of participants
|
4.7 percentage of participants
|
2.6 percentage of participants
|
16.3 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
15.0 percentage of participants
|
12.1 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Grade 3 Anemia
|
14.6 percentage of participants
|
9.8 percentage of participants
|
14.0 percentage of participants
|
10.3 percentage of participants
|
22.4 percentage of participants
|
5.3 percentage of participants
|
19.0 percentage of participants
|
20.0 percentage of participants
|
27.3 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Grade 4 Anemia
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Grade 3 Hb Increase
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Grade 4 Hb Increase
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Grade 3 Leukocytosis
|
34.1 percentage of participants
|
2.4 percentage of participants
|
0 percentage of participants
|
5.1 percentage of participants
|
2.0 percentage of participants
|
52.6 percentage of participants
|
42.9 percentage of participants
|
40.0 percentage of participants
|
30.3 percentage of participants
|
25.0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Grade 4 Leukocytosis
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Hematology Postbaseline Toxicity Grade 3 or Higher
Grade 3 WBC Decrease
|
2.4 percentage of participants
|
12.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
22.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to the last dose date plus 30 days (maximum: 78.4 months)Population: Participants in the Safety Analysis Set were analyzed.
Serum chemistry toxicity at anytime postbaseline was summarized according to the NCI CTCAE, version 4.03. The most severe graded abnormality was counted for each participant per test. ALT = alanine aminotransferase; ALP = alkaline phosphatase; AST = aspartate aminotransferase
Outcome measures
| Measure |
DLBCL: Entospletinib MM/SDD
n=41 Participants
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
MCL: Entospletinib MM/SDD
n=41 Participants
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
n=43 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=39 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
n=49 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=19 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg
n=21 Participants
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg
n=20 Participants
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
n=33 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=8 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
n=6 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=3 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 ALP Increase
|
0 percentage of participants
|
2.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 AST Increase
|
0 percentage of participants
|
4.9 percentage of participants
|
2.3 percentage of participants
|
2.6 percentage of participants
|
2.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Blood Bilirubin Increase
|
7.3 percentage of participants
|
4.9 percentage of participants
|
4.7 percentage of participants
|
0 percentage of participants
|
12.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
10.0 percentage of participants
|
3.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Blood Bilirubin Increase
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Hyponatremia
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 ALP Increase
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 AST Increase
|
7.3 percentage of participants
|
12.2 percentage of participants
|
7.0 percentage of participants
|
10.3 percentage of participants
|
6.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
5.0 percentage of participants
|
3.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 ALT Increase
|
7.3 percentage of participants
|
9.8 percentage of participants
|
9.3 percentage of participants
|
15.4 percentage of participants
|
8.2 percentage of participants
|
0 percentage of participants
|
4.8 percentage of participants
|
5.0 percentage of participants
|
3.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 ALT Increase
|
2.4 percentage of participants
|
9.8 percentage of participants
|
2.3 percentage of participants
|
7.7 percentage of participants
|
4.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
5.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Hypoalbuminemia
|
0 percentage of participants
|
2.4 percentage of participants
|
0 percentage of participants
|
2.6 percentage of participants
|
6.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
5.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Hypoalbuminemia
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Creatine Kinase Decrease
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Creatine Kinase Decrease
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Creatine Kinase Increase
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Creatine Kinase Increase
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Creatinine
|
0 percentage of participants
|
7.3 percentage of participants
|
2.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
5.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Creatinine
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Creatinine Clearance Decrease
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Creatinine Clearance Decrease
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Creatinine Clearance Increase
|
9.8 percentage of participants
|
17.1 percentage of participants
|
2.3 percentage of participants
|
7.7 percentage of participants
|
4.1 percentage of participants
|
10.5 percentage of participants
|
4.8 percentage of participants
|
15.0 percentage of participants
|
12.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Creatinine Clearance Increase
|
0 percentage of participants
|
2.4 percentage of participants
|
2.3 percentage of participants
|
2.6 percentage of participants
|
2.0 percentage of participants
|
5.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Direct Bilirubin Decrease
|
0 percentage of participants
|
2.4 percentage of participants
|
4.7 percentage of participants
|
2.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
3.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Direct Bilirubin Decrease
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Direct Bilirubin Increase
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Direct Bilirubin Increase
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Hyperglycemia
|
9.8 percentage of participants
|
9.8 percentage of participants
|
4.7 percentage of participants
|
10.3 percentage of participants
|
16.3 percentage of participants
|
15.8 percentage of participants
|
9.5 percentage of participants
|
0 percentage of participants
|
18.2 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Hyperglycemia
|
0 percentage of participants
|
2.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Hypoglycemia
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Hypoglycemia
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Hypercalcemia
|
0 percentage of participants
|
2.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
15.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Hypercalcemia
|
0 percentage of participants
|
2.4 percentage of participants
|
2.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Hypocalcemia
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
4.8 percentage of participants
|
0 percentage of participants
|
3.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Hypocalcemia
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
5.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Indirect Bilirubin Decrease
|
4.9 percentage of participants
|
2.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
4.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
10.0 percentage of participants
|
3.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Indirect Bilirubin Decrease
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Indirect Bilirubin Increase
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Indirect Bilirubin Increase
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Hypermagnesemia
|
2.4 percentage of participants
|
2.4 percentage of participants
|
2.3 percentage of participants
|
2.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Hypermagnesemia
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Hypomagnesemia
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Hypomagnesemia
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Hypophosphatemia
|
14.6 percentage of participants
|
4.9 percentage of participants
|
0 percentage of participants
|
7.7 percentage of participants
|
4.1 percentage of participants
|
21.1 percentage of participants
|
14.3 percentage of participants
|
15.0 percentage of participants
|
15.2 percentage of participants
|
12.5 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Hypophosphatemia
|
2.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Hyperkalemia
|
4.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Hyperkalemia
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Hypokalemia
|
7.3 percentage of participants
|
9.8 percentage of participants
|
4.7 percentage of participants
|
0 percentage of participants
|
2.0 percentage of participants
|
5.3 percentage of participants
|
4.8 percentage of participants
|
10.0 percentage of participants
|
3.0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Hypokalemia
|
2.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Hypernatremia
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 4 Hypernatremia
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serum Chemistry Toxicity Postbaseline Grade 3 or Higher
Grade 3 Hyponatremia
|
12.2 percentage of participants
|
2.4 percentage of participants
|
11.6 percentage of participants
|
10.3 percentage of participants
|
12.2 percentage of participants
|
0 percentage of participants
|
4.8 percentage of participants
|
15.0 percentage of participants
|
6.1 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose date until first occurrence of CR or PR (or VGPR or MR for participants with LPL/WM) (up to approximately 7 years)Population: Participants in the Full Analysis Set were analyzed.
ORR: percentage of participants with complete response (CR) or partial response (PR) (or very good PR \[VGPR\] or minor response \[MR\] for participants with LPL/WM). Per 2007 Cheson criteria, CR: complete resolution of all disease-related radiological abnormalities; PR: ≥50% reduction in sum of products (SPD) of the longest diameters of all index lesions, no new lesions; VGPR: \>90% decrease from baseline (DFB) in IgM, and other criteria for CR met; MR: ≥25% but \<50% DFB in IgM, no increase from baseline (IFB) in SPD of lesions, no new lesions. Per IWCLL, CR: lymphocytes (Ly) \<4\*10\^9/L, no lymphadenopathy, normal spleen and liver size, absence of disease, absolute neutrophil count (ANC) \>1.5\*10\^9/L, platelets ≥100\*10\^9/L, hemoglobin (Hb) \>110 g/L, bone marrow at least normocellular for age; PR: ≥2 of these: ≥50% decrease in Ly, lymphadenopathy, size of liver and spleen, bone marrow infiltrates; and ≥1 of these: ANC \>1500/μL, platelets ≥100,000/µL, Hb \>11 g/dL.
Outcome measures
| Measure |
DLBCL: Entospletinib MM/SDD
n=41 Participants
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
MCL: Entospletinib MM/SDD
n=41 Participants
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
n=43 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=39 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
n=49 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=19 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg
n=21 Participants
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg
n=20 Participants
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
n=33 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=8 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
n=6 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=3 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR), as Assessed by IRC Per Standardized Criteria (2007 Cheson Criteria) (for NHL) and IWCLL Criteria (for CLL)
|
53.7 percentage of participants
Interval 37.4 to 69.3
|
17.1 percentage of participants
Interval 7.2 to 32.1
|
0 percentage of participants
Interval 0.0 to 8.2
|
17.9 percentage of participants
Interval 7.5 to 33.5
|
36.7 percentage of participants
Interval 23.4 to 51.7
|
26.3 percentage of participants
Interval 9.1 to 51.2
|
38.1 percentage of participants
Interval 18.1 to 61.6
|
60.0 percentage of participants
Interval 36.1 to 80.9
|
24.2 percentage of participants
Interval 11.1 to 42.3
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
0 percentage of participants
Interval 0.0 to 70.8
|
SECONDARY outcome
Timeframe: From the date of first documentation of CR or PR (or VGPR or MR for participants with LPL/WM) to disease progression or death from any cause (up to approximately 7 years)Population: Participants in the Full Analysis Set with objective response were analyzed.
DOR was defined as the interval from first documentation of CR or PR (or VGPR or MR for participants with LPL/WM) to earlier of first documentation of definitive disease progression or death from any cause. Per 2007 Cheson criteria, CR: complete resolution of all disease-related radiological abnormalities; PR: ≥50% reduction in SPD of longest diameters of all index lesions, no new lesions; VGPR: \>90% DFB in IgM, and other criteria for CR met; MR: ≥25% but \<50% DFB in IgM, no IFB in SPD of lesions, no new lesions. Per IWCLL criteria, CR: Ly \<4\*10\^9/L, no lymphadenopathy, normal spleen and liver size, absence of disease, ANC \>1.5\*10\^9/L, platelets ≥100\*10\^9/L, Hb \>110 g/L, bone marrow at least normocellular for age; PR: ≥2 of these: ≥50% decrease in Ly, lymphadenopathy, size of liver and spleen, bone marrow infiltrates; and ≥1 of these: ANC\>1500/μL, platelets ≥100,000/µL, Hb \>11 g/dL. Disease progression: as defined in Outcome measure 1. DOR was analyzed using KM estimates.
Outcome measures
| Measure |
DLBCL: Entospletinib MM/SDD
n=22 Participants
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
MCL: Entospletinib MM/SDD
n=7 Participants
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=7 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
n=18 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=5 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg
n=8 Participants
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg
n=12 Participants
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
n=8 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=6 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
n=2 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR), as Assessed by IRC Per Standardized Criteria (2007 Cheson Criteria) (for NHL) and IWCLL Criteria (for CLL)
|
22 months
Interval 12.7 to 36.7
|
7.6 months
Interval 2.2 to
Due to less number of participants with an event, upper limit of 95% CI could not be estimable.
|
—
|
7.5 months
Interval 1.9 to 14.3
|
19 months
Interval 9.0 to 56.0
|
26.9 months
Interval 1.7 to 42.3
|
14.9 months
Interval 1.2 to 41.3
|
17. months
Interval 9.0 to 39.2
|
8.1 months
Interval 1.2 to
Due to less number of participants with an event, upper limit of 95% CI could not be estimable.
|
11.3 months
Interval 3.4 to
Due to less number of participants with an event, upper limit of 95% CI could not be estimable.
|
2.7 months
Interval 1.6 to 3.8
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study drug to the first documentation of CR or PR (or VGPR or MR for participants with LPL/WM) (up to approximately 7 years)Population: Participants in the Full Analysis Set with available data were analyzed.
TTR was defined as the interval from the first dose of study drug to the first documentation of CR or PR (or VGPR or MR for participants with LPL/WM). Per 2007 Cheson criteria, CR: complete resolution of all disease-related radiological abnormalities; PR: ≥ 50% reduction in SPD of the longest diameters of all index lesions, no new lesions; VGPR: \>90% DFB in IgM, and other criteria for CR met; MR: ≥25% but \<50% DFB in IgM, no IFB in SPD of lesions, no new lesions. Per IWCLL criteria, CR: Ly \<4\*10\^9/L, no lymphadenopathy, normal spleen and liver size, absence of disease, ANC \>1.5\*10\^9/L, platelets ≥100\*10\^9/L, Hb \>110 g/L, bone marrow at least normocellular for age; PR: ≥2 of these: ≥50% decrease in Ly, lymphadenopathy, size of liver and spleen, bone marrow infiltrates; and ≥1 of these: ANC \>1500/μL, platelets ≥100,000/µL, Hb \>11 g/dL.
Outcome measures
| Measure |
DLBCL: Entospletinib MM/SDD
n=22 Participants
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
MCL: Entospletinib MM/SDD
n=7 Participants
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=7 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
n=18 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=5 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg
n=8 Participants
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg
n=12 Participants
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
n=8 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=6 Participants
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
n=2 Participants
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Response (TTR), as Assessed by IRC Per Standardized Criteria (2007 Cheson Criteria) (for NHL) and IWCLL Criteria (for CLL)
|
3.2 months
Standard Deviation 2.15
|
7.5 months
Standard Deviation 4.40
|
—
|
4.6 months
Standard Deviation 4.65
|
2.8 months
Standard Deviation 2.31
|
6.4 months
Standard Deviation 5.93
|
3.5 months
Standard Deviation 2.39
|
6.8 months
Standard Deviation 4.33
|
4.0 months
Standard Deviation 2.75
|
3.4 months
Standard Deviation 1.82
|
1.8 months
Standard Deviation 0.05
|
—
|
Adverse Events
CLL: Entospletinib MM/SDD
Serious events: 17 serious events
Other events: 40 other events
Deaths: 4 deaths
FL: Entospletinib MM/SDD
Serious events: 9 serious events
Other events: 39 other events
Deaths: 3 deaths
DLBCL: Entospletinib MM/SDD
Serious events: 16 serious events
Other events: 42 other events
Deaths: 13 deaths
MCL: Entospletinib MM/SDD
Serious events: 16 serious events
Other events: 38 other events
Deaths: 6 deaths
Non-FL iNHL: Entospletinib MM/SDD
Serious events: 22 serious events
Other events: 49 other events
Deaths: 5 deaths
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 100 mg
Serious events: 8 serious events
Other events: 19 other events
Deaths: 0 deaths
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg
Serious events: 10 serious events
Other events: 19 other events
Deaths: 1 deaths
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg
Serious events: 8 serious events
Other events: 20 other events
Deaths: 1 deaths
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
Serious events: 15 serious events
Other events: 33 other events
Deaths: 3 deaths
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
Serious events: 3 serious events
Other events: 8 other events
Deaths: 1 deaths
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
Serious events: 4 serious events
Other events: 5 other events
Deaths: 3 deaths
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CLL: Entospletinib MM/SDD
n=41 participants at risk
Participants with CLL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
FL: Entospletinib MM/SDD
n=41 participants at risk
Participants with FL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
DLBCL: Entospletinib MM/SDD
n=43 participants at risk
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
MCL: Entospletinib MM/SDD
n=39 participants at risk
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
Non-FL iNHL: Entospletinib MM/SDD
n=49 participants at risk
Participants with iNHL (ie, participants with LPL/WM, SLL, or MZL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 100 mg
n=19 participants at risk
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg
n=21 participants at risk
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg
n=20 participants at risk
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
n=33 participants at risk
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=8 participants at risk
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
n=6 participants at risk
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=3 participants at risk
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Bandaemia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Cardiac disorders
Angina pectoris
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Cardiac disorders
Pericardial effusion
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Cardiac disorders
Pericarditis
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Asthenia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Chest pain
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Fatigue
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Gait inability
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Generalised oedema
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Non-cardiac chest pain
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Pyrexia
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Abscess soft tissue
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Cellulitis
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Epiglottitis
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
H1n1 influenza
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Pneumonia
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.0%
3/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
3/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
21.1%
4/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Pulmonary sepsis
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Rotavirus infection
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Sepsis
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Septic shock
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Staphylococcal infection
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Cerebral ischaemia
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Encephalopathy
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.7%
3/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
Other adverse events
| Measure |
CLL: Entospletinib MM/SDD
n=41 participants at risk
Participants with CLL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
FL: Entospletinib MM/SDD
n=41 participants at risk
Participants with FL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
DLBCL: Entospletinib MM/SDD
n=43 participants at risk
Participants with DLBCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
MCL: Entospletinib MM/SDD
n=39 participants at risk
Participants with MCL, received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
Non-FL iNHL: Entospletinib MM/SDD
n=49 participants at risk
Participants with iNHL (ie, participants with LPL/WM, SLL, or MZL), received original formulation of entospletinib 800 mg (4 × 200 mg tablets) (before amendment 8) or new formulation of entospletinib 400 mg (2 × 200 mg tablets) (after amendment 8) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 100 mg
n=19 participants at risk
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 100 mg (1 × 100 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 200 mg
n=21 participants at risk
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib 200 mg (1 × 200 mg tablet) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL, Prior BCR Inhibitor Naive: Entospletinib SDD 400 mg
n=20 participants at risk
Participants with CLL, who were prior BCR inhibitor naive, received new formulation of entospletinib (SDD) 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior BTK Inhibitor: Entospletinib SDD
n=33 participants at risk
Participants with CLL and simple progression (non-Richters), who were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Non-Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=8 participants at risk
Participants with CLL and simple progression (non-Richters), who were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior BTK Inhibitor: Entospletinib SDD
n=6 participants at risk
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to BTK inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
CLL (Richters) Prior PI3K Inhibitor: Entospletinib SDD
n=3 participants at risk
Participants with CLL, who transformed to Richters or Richters-like syndrome and were exposed to PI3K inhibitor, received new formulation of entospletinib 400 mg (2 × 200 mg tablets) orally twice daily. Treatment with entospletinib was continued until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Oral herpes
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Sinusitis
|
17.1%
7/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.7%
3/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.2%
5/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.0%
3/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
29.3%
12/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
17.1%
7/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.6%
11/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.4%
6/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
18.4%
9/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
31.6%
6/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
7/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.0%
3/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
39.4%
13/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
2/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Hypoglobulinaemia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
3/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.6%
6/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.0%
3/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
24.5%
12/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.0%
3/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.2%
5/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
37.5%
3/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
14.6%
6/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.0%
3/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.3%
4/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
18.4%
9/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
19.0%
4/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.1%
4/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Cardiac disorders
Palpitations
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
3/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.0%
2/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Cardiac disorders
Tachycardia
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
8.2%
4/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Eye disorders
Vision blurred
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Ear and labyrinth disorders
Ear discomfort
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
8.2%
4/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Eye disorders
Cataract
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Eye disorders
Dry eye
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Eye disorders
Eye pain
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Eye disorders
Photophobia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Eye disorders
Visual impairment
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.0%
3/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.0%
2/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.7%
3/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
8.2%
4/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.2%
5/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.2%
5/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.3%
7/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.4%
6/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.2%
5/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.0%
3/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.7%
3/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
3/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Constipation
|
24.4%
10/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
19.5%
8/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
27.9%
12/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
28.2%
11/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
34.7%
17/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
31.6%
6/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
23.8%
5/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
20.0%
4/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
24.2%
8/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.0%
2/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
58.5%
24/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
39.0%
16/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.6%
11/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
59.0%
23/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
36.7%
18/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
47.4%
9/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
52.4%
11/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
30.0%
6/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
51.5%
17/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
87.5%
7/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
2/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Oedema
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.2%
5/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
14.6%
6/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
17.9%
7/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
20.4%
10/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.0%
3/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.0%
2/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.7%
3/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Flatulence
|
12.2%
5/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.2%
5/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.0%
3/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.2%
5/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Gingival discomfort
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Bronchitis
|
12.2%
5/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
3/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
14.3%
3/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Nausea
|
46.3%
19/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
51.2%
21/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
41.9%
18/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
43.6%
17/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
57.1%
28/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
47.4%
9/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
7/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
45.0%
9/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
36.4%
12/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
50.0%
4/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Oral mucosal exfoliation
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Palatal oedema
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Rectal discharge
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
8.2%
4/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
8.2%
4/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Gastrointestinal disorders
Vomiting
|
14.6%
6/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
24.4%
10/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
14.0%
6/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.4%
6/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
26.5%
13/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.8%
3/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
28.6%
6/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
20.0%
4/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
18.2%
6/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Asthenia
|
14.6%
6/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.0%
3/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.7%
3/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
3/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Chest pain
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.0%
3/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Chills
|
14.6%
6/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
17.1%
7/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.3%
4/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.3%
8/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
21.1%
4/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
14.3%
3/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Complication associated with device
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Fatigue
|
63.4%
26/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
53.7%
22/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
41.9%
18/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
59.0%
23/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
67.3%
33/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
47.4%
9/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
52.4%
11/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
70.0%
14/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
57.6%
19/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
50.0%
4/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
2/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Generalised oedema
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Influenza like illness
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.0%
2/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Injection site bruising
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Malaise
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Mucosal inflammation
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Nodule
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Oedema peripheral
|
24.4%
10/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
20.9%
9/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.8%
5/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.3%
8/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.8%
3/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
23.8%
5/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.0%
3/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.2%
5/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Pain
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Peripheral swelling
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Candida infection
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Pyrexia
|
29.3%
12/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
22.0%
9/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.3%
4/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
20.5%
8/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
24.5%
12/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
26.3%
5/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
14.3%
3/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.0%
3/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
18.2%
6/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Swelling
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Tenderness
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
General disorders
Thirst
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
8.2%
4/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Immune system disorders
Allergy to arthropod bite
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Immune system disorders
Seasonal allergy
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Alpha haemolytic streptococcal infection
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Cellulitis
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
14.3%
3/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Chronic sinusitis
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Conjunctivitis
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Herpes zoster
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.8%
3/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.0%
2/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Impetigo
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
3/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
3/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.1%
4/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Oral candidiasis
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Paronychia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Pharyngitis
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Pneumonia
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
14.3%
7/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
19.0%
4/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.0%
3/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.1%
4/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Skin infection
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
34.1%
14/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
17.1%
7/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.4%
6/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
18.4%
9/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
36.8%
7/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
14.3%
3/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
35.0%
7/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
21.2%
7/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
37.5%
3/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Urinary tract infection
|
19.5%
8/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.2%
5/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
11.6%
5/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.3%
4/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
3/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
26.3%
5/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
14.3%
3/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.0%
3/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.1%
4/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
2/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.2%
5/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.0%
2/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
14.6%
6/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.7%
3/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.2%
6/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Alanine aminotransferase increased
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
17.1%
7/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.3%
4/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
17.9%
7/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.2%
5/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.0%
2/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
17.1%
7/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
14.0%
6/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.8%
5/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.0%
2/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.2%
5/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.0%
3/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Blood bilirubin increased
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
22.0%
9/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
11.6%
5/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
14.3%
7/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.0%
2/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Blood creatinine increased
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.2%
5/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.3%
4/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.3%
4/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
3/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.0%
3/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.1%
4/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.2%
5/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
11.6%
5/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
8.2%
4/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.8%
3/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
2/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Heart rate increased
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
High density lipoprotein decreased
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Lymph node palpable
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Lymphocyte count increased
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Neutrophil count decreased
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Protein total decreased
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Transaminases increased
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Weight decreased
|
12.2%
5/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.3%
4/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.8%
5/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
30.0%
6/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.1%
4/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
Weight increased
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Investigations
White blood cell count increased
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
29.3%
12/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
22.0%
9/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
37.2%
16/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
13/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
22.4%
11/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
19.0%
4/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.0%
5/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
18.2%
6/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.0%
2/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
14.6%
6/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
18.6%
8/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.3%
4/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
18.4%
9/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
21.1%
4/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
19.0%
4/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.3%
4/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.0%
3/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
8.2%
4/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.3%
4/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
3/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.6%
6/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
11.6%
5/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.7%
3/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.2%
6/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.4%
10/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
14.6%
6/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.2%
6/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.8%
3/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
14.3%
3/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
37.5%
3/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
11.6%
5/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.3%
4/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.3%
8/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
21.1%
4/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
20.0%
4/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.0%
2/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
8.2%
4/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.2%
5/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.7%
3/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.2%
6/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
19.0%
4/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.0%
3/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.0%
3/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
8.2%
4/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.8%
3/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.0%
3/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.7%
3/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.7%
3/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.8%
3/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.0%
2/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
12.2%
5/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Dizziness
|
31.7%
13/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
22.0%
9/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
14.0%
6/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
20.5%
8/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
18.4%
9/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.8%
3/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
45.0%
9/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
21.2%
7/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
50.0%
4/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Dysgeusia
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Headache
|
34.1%
14/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
22.0%
9/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.3%
4/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.4%
6/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
20.4%
10/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
28.6%
6/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.0%
3/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
50.0%
4/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Memory impairment
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Migraine
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.8%
3/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Paraesthesia
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Post herpetic neuralgia
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Restless legs syndrome
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Somnolence
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Syncope
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Taste disorder
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
8.2%
4/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Nervous system disorders
Tremor
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.3%
4/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
3/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Psychiatric disorders
Agitation
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Psychiatric disorders
Anxiety
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
14.0%
6/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.7%
3/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
8.2%
4/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
14.3%
3/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.0%
2/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Psychiatric disorders
Depression
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.8%
5/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
8.2%
4/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.0%
3/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Psychiatric disorders
Insomnia
|
17.1%
7/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
20.9%
9/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.7%
3/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
24.5%
12/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
20.0%
4/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.1%
4/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.0%
2/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Psychiatric disorders
Mental status changes
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.7%
3/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
2/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
3/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Haematuria
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.7%
3/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
8.2%
4/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Proteinuria
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Renal cyst
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Urinary retention
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Renal and urinary disorders
Urine abnormality
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.3%
12/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
19.5%
8/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
20.9%
9/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.6%
10/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
34.7%
17/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
26.3%
5/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
42.9%
9/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
50.0%
10/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
36.4%
12/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.1%
7/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
27.9%
12/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.4%
6/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
14.3%
7/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
19.0%
4/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.1%
4/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
3/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.3%
4/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.2%
5/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
3/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.0%
3/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.3%
4/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.2%
6/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.0%
2/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary cavitation
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.0%
3/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.2%
5/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.0%
3/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar disorder
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
3/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
3/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
14.6%
6/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.3%
4/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.2%
6/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
19.0%
4/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
1/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
17.1%
7/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.3%
4/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
14.3%
7/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.0%
2/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
17.1%
7/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.1%
2/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
22.4%
11/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.5%
2/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.5%
2/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.0%
3/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
25.0%
2/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.7%
2/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.8%
4/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
9.1%
3/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.3%
1/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
8.2%
4/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Skin and subcutaneous tissue disorders
Transient acantholytic dermatosis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Vascular disorders
Embolism
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Vascular disorders
Flushing
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Vascular disorders
Haematoma
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
6.1%
2/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
16.7%
1/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Vascular disorders
Hot flush
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.1%
2/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
3.0%
1/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Vascular disorders
Hypertension
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.4%
1/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.6%
1/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
2.0%
1/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.0%
1/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Vascular disorders
Hypotension
|
7.3%
3/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.9%
2/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.0%
3/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
7.7%
3/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
10.2%
5/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
5.3%
1/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
4.8%
1/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
15.2%
5/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
33.3%
2/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/41 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/43 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/39 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/49 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/19 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/21 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/20 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/33 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
12.5%
1/8 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/6 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
0.00%
0/3 • Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 78.4 months); All-Cause Mortality: From enrollment up to approximately 7 years
The Safety Analysis Set included all participants who took at least one dose of study drug with treatment group designated according to the actual treatment.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER