Trial Outcomes & Findings for A Study of LY3022855 In Participants With Breast or Prostate Cancer (NCT NCT02265536)
NCT ID: NCT02265536
Last Updated: 2024-10-28
Results Overview
The immunomodulatory activity of the drug was documented by examining markers that include, but are not limited to: Live-Dead, Cluster of Differentiation 3 (CD3), CD4, CD8, CD14, CD16, Foxhead Box p3 (FoxP3), PD-1, Ki-67, Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4), Human Leukocyte Antigen-D-relate (HLA-DR), T-cell immunoglobulin and mucin-3 (TIM-3), lymphocyte-activation gene 3 (LAG-3), and Inducible T-cell COStimulator (ICOS). The expression of these markers was quantified by flow cytometric analysis with an antibody panel.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Baseline to Day 8 after 1st dose
Results posted on
2024-10-28
Participant Flow
Completers included participants who died from any cause or disease progression and participants who were alive and on study (either on study treatment or in long term follow-up) at study conclusion.
Participant milestones
| Measure |
LY3022855 - 1.25 mg/kg Q2W Breast Cancer
Participants received 1.25 milligram per kilogram (mg/kg) of LY3022855 administered intravenously (IV) once every two weeks (Q2W) of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
|
LY3022855 - 100 mg Q2W Breast Cancer
Participants received 100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 100 mg QW Breast Cancer
Participants received 100 mg of LY3022855 administered IV once weekly (QW) of a 6-week cycle.
|
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
5
|
6
|
8
|
4
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
6
|
5
|
5
|
6
|
8
|
4
|
|
Overall Study
COMPLETED
|
5
|
2
|
5
|
6
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
0
|
0
|
3
|
0
|
Reasons for withdrawal
| Measure |
LY3022855 - 1.25 mg/kg Q2W Breast Cancer
Participants received 1.25 milligram per kilogram (mg/kg) of LY3022855 administered intravenously (IV) once every two weeks (Q2W) of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
|
LY3022855 - 100 mg Q2W Breast Cancer
Participants received 100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 100 mg QW Breast Cancer
Participants received 100 mg of LY3022855 administered IV once weekly (QW) of a 6-week cycle.
|
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY3022855 In Participants With Breast or Prostate Cancer
Baseline characteristics by cohort
| Measure |
LY3022855 - 1.25 mg/kg Q2W Breast Cancer
n=6 Participants
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer
n=5 Participants
Participants received 1.0 mg/kg of LY3022855 administered IV on weeks 1, 2, 4, and 5 of a 6-week cycle.
|
LY3022855 - 100 mg Q2W Breast Cancer
n=5 Participants
Participants received 100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 100 mg QW Breast Cancer
n=6 Participants
Participants received 100 mg of LY3022855 administered IV once weekly of a 6-week cycle.
|
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer
n=8 Participants
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer
n=4 Participants
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks 1, 2, 4, and 5 of a 6-week cycle.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.5 Years
STANDARD_DEVIATION 16.6 • n=5 Participants
|
55.4 Years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
54.8 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
58.3 Years
STANDARD_DEVIATION 16.1 • n=4 Participants
|
69.8 Years
STANDARD_DEVIATION 8.3 • n=21 Participants
|
71.0 Years
STANDARD_DEVIATION 9.2 • n=8 Participants
|
60.7 Years
STANDARD_DEVIATION 13.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
|
Body Mass Index (BMI)
|
27.3 Kilogram/Meter^2 (kg/m^2)
STANDARD_DEVIATION 6.0 • n=5 Participants
|
26.5 Kilogram/Meter^2 (kg/m^2)
STANDARD_DEVIATION 6.0 • n=7 Participants
|
24.2 Kilogram/Meter^2 (kg/m^2)
STANDARD_DEVIATION 4.8 • n=5 Participants
|
25.1 Kilogram/Meter^2 (kg/m^2)
STANDARD_DEVIATION 4.5 • n=4 Participants
|
27.8 Kilogram/Meter^2 (kg/m^2)
STANDARD_DEVIATION 3.4 • n=21 Participants
|
28.6 Kilogram/Meter^2 (kg/m^2)
STANDARD_DEVIATION 6.2 • n=8 Participants
|
26.6 Kilogram/Meter^2 (kg/m^2)
STANDARD_DEVIATION 4.9 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 8 after 1st dosePopulation: All enrolled participants who received at least one dose of study drug and have baseline and post baseline data for peripheral blood immune cell subsets.
The immunomodulatory activity of the drug was documented by examining markers that include, but are not limited to: Live-Dead, Cluster of Differentiation 3 (CD3), CD4, CD8, CD14, CD16, Foxhead Box p3 (FoxP3), PD-1, Ki-67, Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4), Human Leukocyte Antigen-D-relate (HLA-DR), T-cell immunoglobulin and mucin-3 (TIM-3), lymphocyte-activation gene 3 (LAG-3), and Inducible T-cell COStimulator (ICOS). The expression of these markers was quantified by flow cytometric analysis with an antibody panel.
Outcome measures
| Measure |
LY3022855 - 1.25 mg/kg Q2W Breast Cancer
n=6 Participants
Participants received 1.25 milligram per kilogram (mg/kg) of LY3022855 administered intravenously (IV) once every two weeks (Q2W) of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer
n=5 Participants
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
|
LY3022855 - 100 mg Q2W Breast Cancer
n=5 Participants
Participants received 100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 100 mg QW Breast Cancer
n=6 Participants
Participants received 100 mg of LY3022855 administered IV once weekly (QW) of a 6-week cycle.
|
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer
n=8 Participants
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer
n=4 Participants
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
CD4_CD3_%
|
1.81 Percent Change
Interval -2.97 to 9.84
|
3.18 Percent Change
Interval -0.35 to 5.16
|
-3.01 Percent Change
Interval -4.49 to 0.29
|
-0.15 Percent Change
Interval -14.67 to 10.5
|
0.41 Percent Change
Interval -1.24 to 1.67
|
7.34 Percent Change
Interval 0.0 to 10.65
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
CD4_CNT
|
-13.02 Percent Change
Interval -22.31 to 2.58
|
43.43 Percent Change
Interval -6.95 to 86.22
|
2.87 Percent Change
Interval -17.63 to 13.04
|
-18.79 Percent Change
Interval -38.14 to 17.61
|
11.31 Percent Change
Interval -2.75 to 18.02
|
4.65 Percent Change
Interval -1.27 to 7.45
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
CD3_LIVE_%
|
-3.54 Percent Change
Interval -17.62 to 5.09
|
16.63 Percent Change
Interval -11.76 to 33.86
|
20.32 Percent Change
Interval 13.89 to 36.08
|
-5.33 Percent Change
Interval -8.5 to 4.87
|
8.11 Percent Change
Interval -4.29 to 20.15
|
-5.11 Percent Change
Interval -10.76 to -1.17
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
CD8_CD3_%
|
-4.02 Percent Change
Interval -10.44 to 4.76
|
-4.5 Percent Change
Interval -9.56 to 3.45
|
1.96 Percent Change
Interval -7.73 to 8.53
|
28.25 Percent Change
Interval 13.74 to 37.77
|
0 Percent Change
Interval -8.71 to 4.82
|
-9.91 Percent Change
Interval -16.93 to 11.77
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
CD8_CD4_RATIO
|
-5.53 Percent Change
Interval -18.34 to 7.93
|
-7.44 Percent Change
Interval -13.77 to 4.7
|
0.01 Percent Change
Interval -10.97 to 11.13
|
32.87 Percent Change
Interval 21.0 to 49.28
|
0.4 Percent Change
Interval -11.34 to 5.67
|
-16.13 Percent Change
Interval -24.67 to 14.1
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
CD8_CNT
|
-6.41 Percent Change
Interval -28.35 to -0.63
|
29.87 Percent Change
Interval -11.54 to 61.92
|
4.58 Percent Change
Interval -25.47 to 26.47
|
-9.9 Percent Change
Interval -12.59 to 51.2
|
13.01 Percent Change
Interval -10.94 to 18.46
|
-12.32 Percent Change
Interval -25.17 to 23.42
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
CD8_FOXP3_RATIO
|
-10.61 Percent Change
Interval -18.7 to -1.07
|
-17.56 Percent Change
Interval -19.76 to 3.97
|
28.48 Percent Change
Interval 18.76 to 38.75
|
123.96 Percent Change
Interval 10.17 to 230.5
|
-4.12 Percent Change
Interval -21.58 to 11.66
|
-0.64 Percent Change
Interval -4.91 to 15.96
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
CTLA4_CD4_%
|
4.14 Percent Change
Interval -6.63 to 13.34
|
18.49 Percent Change
Interval -3.27 to 36.61
|
-26.26 Percent Change
Interval -37.0 to -15.26
|
2.18 Percent Change
Interval -30.98 to 31.16
|
31.67 Percent Change
Interval 1.37 to 44.97
|
3.59 Percent Change
Interval -9.12 to 13.74
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
CTLA4_CD8_%
|
-7.34 Percent Change
Interval -16.22 to 9.76
|
19.43 Percent Change
Interval -56.63 to 97.71
|
-21.33 Percent Change
Interval -25.18 to -3.45
|
-11 Percent Change
Interval -50.03 to 56.66
|
7.48 Percent Change
Interval -4.19 to 35.05
|
-10.32 Percent Change
Interval -24.03 to 47.92
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
FOXP3_CD4_%
|
26.31 Percent Change
Interval -2.0 to 30.37
|
2.39 Percent Change
Interval -11.76 to 14.97
|
-21.12 Percent Change
Interval -39.09 to -1.69
|
-33.46 Percent Change
Interval -45.31 to -13.45
|
13.51 Percent Change
Interval -11.69 to 18.56
|
-7.74 Percent Change
Interval -20.29 to 0.38
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
FOXP3_CD8_%
|
35.94 Percent Change
Interval 21.09 to 39.73
|
-7.17 Percent Change
Interval -32.96 to 2.97
|
-48.43 Percent Change
Interval -49.7 to -46.03
|
-33.81 Percent Change
Interval -69.36 to 2.12
|
20.36 Percent Change
Interval 12.26 to 58.96
|
52.01 Percent Change
Interval 8.22 to 84.24
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
FOXP3_CNT
|
-7.43 Percent Change
Interval -22.89 to 16.7
|
63.34 Percent Change
Interval 6.29 to 97.2
|
-18.38 Percent Change
Interval -51.04 to 11.19
|
-51.05 Percent Change
Interval -72.49 to -11.58
|
2.37 Percent Change
Interval -8.31 to 29.16
|
-3.16 Percent Change
Interval -20.42 to 8.25
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
C14_HLA_DR_%
|
-10.31 Percent Change
Interval -39.58 to -9.05
|
5.12 Percent Change
Interval 1.54 to 26.3
|
-16.39 Percent Change
Interval -21.73 to -11.05
|
-26.76 Percent Change
Interval -28.66 to -24.87
|
-11.77 Percent Change
Interval -19.97 to -1.71
|
-11.72 Percent Change
Interval -15.71 to -7.73
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
LIVE_CELL_Count (CNT)
|
-9.85 Percent Change
Interval -13.45 to -3.18
|
-20.08 Percent Change
Interval -26.37 to -1.67
|
-12.82 Percent Change
Interval -39.07 to 4.13
|
1.23 Percent Change
Interval -7.11 to 10.71
|
0.43 Percent Change
Interval -10.33 to 7.02
|
-3.48 Percent Change
Interval -3.82 to -3.28
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
CD3_CNT
|
-10.53 Percent Change
Interval -24.82 to -0.59
|
39.23 Percent Change
Interval -8.69 to 77.95
|
1.92 Percent Change
Interval -20.92 to 16.58
|
-19.27 Percent Change
Interval -27.82 to 17.61
|
12.35 Percent Change
Interval -3.29 to 19.26
|
-2.35 Percent Change
Interval -10.44 to 8.31
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
ICOS_CD4_%
|
-5.72 Percent Change
Interval -12.92 to -2.46
|
0.77 Percent Change
Interval -5.46 to 25.56
|
-14.6 Percent Change
Interval -24.04 to -0.44
|
17.69 Percent Change
Interval -4.46 to 32.57
|
30.4 Percent Change
Interval -0.37 to 46.77
|
17.76 Percent Change
Interval 2.74 to 48.27
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
ICOS_CD8_%
|
3.75 Percent Change
Interval -19.71 to 8.05
|
17.18 Percent Change
Interval -8.75 to 31.03
|
-30 Percent Change
Interval -38.78 to -7.52
|
-18.81 Percent Change
Interval -35.45 to 10.09
|
9.08 Percent Change
Interval -28.61 to 23.41
|
-25.12 Percent Change
Interval -26.37 to -23.36
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
KI67_CD4_%
|
-17.44 Percent Change
Interval -24.98 to -7.28
|
70.56 Percent Change
Interval 19.8 to 101.12
|
-30.52 Percent Change
Interval -36.48 to -26.81
|
-6.57 Percent Change
Interval -51.21 to 63.09
|
0.19 Percent Change
Interval -10.34 to 73.56
|
8.18 Percent Change
Interval -9.64 to 62.58
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
KI67_CD8_%
|
-27.13 Percent Change
Interval -54.17 to 0.66
|
17.47 Percent Change
Interval -12.49 to 60.93
|
-15.46 Percent Change
Interval -27.25 to 0.17
|
-7.75 Percent Change
Interval -54.51 to 70.84
|
-6.48 Percent Change
Interval -20.64 to 63.7
|
-3.75 Percent Change
Interval -15.92 to 64.4
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
LAG3_CD4_%
|
87.25 Percent Change
Interval 44.31 to 106.7
|
-18.38 Percent Change
Interval -42.96 to 10.36
|
-15.67 Percent Change
Interval -38.96 to 31.72
|
10.35 Percent Change
Interval -14.07 to 44.06
|
40.36 Percent Change
Interval 17.91 to 74.15
|
9.74 Percent Change
Interval 9.68 to 16.55
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
LAG3_CD8_%
|
59.83 Percent Change
Interval 9.63 to 101.28
|
-24.98 Percent Change
Interval -31.79 to -13.65
|
3.48 Percent Change
Interval -26.54 to 42.81
|
69.63 Percent Change
Interval 45.48 to 98.24
|
7.87 Percent Change
Interval -2.89 to 58.77
|
80.24 Percent Change
Interval 23.83 to 81.04
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
PD1_CD4_%
|
-6.58 Percent Change
Interval -12.48 to 3.18
|
15.71 Percent Change
Interval 11.46 to 22.05
|
-5.25 Percent Change
Interval -12.67 to 4.02
|
19.18 Percent Change
Interval 6.39 to 26.88
|
-13.58 Percent Change
Interval -28.27 to 10.3
|
4.14 Percent Change
Interval -3.18 to 50.31
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
PD1_CD8_%
|
-14.49 Percent Change
Interval -18.09 to -8.19
|
8.32 Percent Change
Interval -9.13 to 25.82
|
-2.49 Percent Change
Interval -17.22 to 21.96
|
20.59 Percent Change
Interval 9.1 to 24.82
|
-11.85 Percent Change
Interval -20.0 to 20.32
|
-2.2 Percent Change
Interval -15.81 to 35.46
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
TIM3_CD4_%
|
-36.63 Percent Change
Interval -38.64 to -16.56
|
-29.87 Percent Change
Interval -30.86 to -0.59
|
-15.45 Percent Change
Interval -21.9 to -8.64
|
-21.93 Percent Change
Interval -40.21 to -7.64
|
-12.12 Percent Change
Interval -19.61 to -0.92
|
-18.49 Percent Change
Interval -25.07 to -12.18
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
TIM3_CD8_%
|
1.53 Percent Change
Interval -4.03 to 24.46
|
1.69 Percent Change
Interval -12.29 to 16.18
|
6.18 Percent Change
Interval -13.76 to 25.2
|
-16.65 Percent Change
Interval -21.76 to -4.47
|
0.7 Percent Change
Interval -20.5 to 31.25
|
-33.08 Percent Change
Interval -43.49 to -30.02
|
|
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
CD14DIM_CD16BR_%
|
-95.12 Percent Change
Interval -96.15 to 72.73
|
12.24 Percent Change
Interval -40.59 to 25.44
|
-60.59 Percent Change
Interval -82.14 to -10.19
|
-95.09 Percent Change
Interval -96.81 to -91.77
|
-88.73 Percent Change
Interval -94.44 to -75.81
|
-92.73 Percent Change
Interval -95.2 to -52.61
|
PRIMARY outcome
Timeframe: Baseline to Day 8 after 1st dosePopulation: All enrolled participants who received at least one dose of study drug and have baseline and post baseline data for Serum Cytokines.
The immunomodulatory activity of the drug was measured in participants with advanced, refractory breast or prostate cancers using serum cytokines. Serum cytokine levels was determined by MSD multiplex cytokine immunoassay technology or ELISA, and that may include but not be limited to Interleukin 6 (IL-6), IL-8, IL-10 and Tumor necrosis factor (TNF-α).
Outcome measures
| Measure |
LY3022855 - 1.25 mg/kg Q2W Breast Cancer
n=6 Participants
Participants received 1.25 milligram per kilogram (mg/kg) of LY3022855 administered intravenously (IV) once every two weeks (Q2W) of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer
n=5 Participants
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
|
LY3022855 - 100 mg Q2W Breast Cancer
n=5 Participants
Participants received 100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 100 mg QW Breast Cancer
n=6 Participants
Participants received 100 mg of LY3022855 administered IV once weekly (QW) of a 6-week cycle.
|
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer
n=8 Participants
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer
n=4 Participants
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Serum Cytokines
IL-10
|
83.3 Percent Change
Interval 45.6 to 94.11
|
12.69 Percent Change
Interval -41.7 to 95.05
|
—
|
—
|
174.75 Percent Change
Interval 139.08 to 191.88
|
—
|
|
Percentage Change From Baseline in Serum Cytokines
TNF-α
|
-14.51 Percent Change
Interval -19.84 to 81.88
|
48.28 Percent Change
Interval 16.56 to 61.5
|
416.95 Percent Change
Interval 416.95 to 416.95
|
3.51 Percent Change
Interval -21.14 to 14.91
|
6.1 Percent Change
Interval -14.11 to 61.5
|
—
|
|
Percentage Change From Baseline in Serum Cytokines
IL-8
|
24.53 Percent Change
Interval 18.82 to 7901.0
|
62.84 Percent Change
Interval -38.78 to 189.47
|
1956.66 Percent Change
Interval 1108.74 to 2804.58
|
-19.97 Percent Change
Interval -41.55 to 435.42
|
67.42 Percent Change
Interval 29.18 to 122.35
|
-7.62 Percent Change
Interval -51.64 to 57.42
|
|
Percentage Change From Baseline in Serum Cytokines
IL-6
|
18.13 Percent Change
Interval -38.15 to 35.79
|
35.76 Percent Change
Interval -9.31 to 72.08
|
1956.66 Percent Change
Interval 1108.74 to 2804.58
|
-19.97 Percent Change
Interval -41.55 to 435.42
|
67.42 Percent Change
Interval 29.18 to 122.35
|
-7.62 Percent Change
Interval -51.64 to 57.42
|
PRIMARY outcome
Timeframe: Day 8Population: All enrolled participants who received at least one dose of study drug and have baseline and post baseline data for Serum Cytokines.
The immunomodulatory activity of the drug was measured in participants with advanced, refractory breast or prostate cancers using serum cytokines. Serum cytokines will be determined by MSD multiplex cytokine immunoassay or ELISA. The markers to be measured using these technologies include, but are not limited to: CSF-1, IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, IL-34, and TNF-α.
Outcome measures
| Measure |
LY3022855 - 1.25 mg/kg Q2W Breast Cancer
n=6 Participants
Participants received 1.25 milligram per kilogram (mg/kg) of LY3022855 administered intravenously (IV) once every two weeks (Q2W) of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer
n=4 Participants
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
|
LY3022855 - 100 mg Q2W Breast Cancer
n=5 Participants
Participants received 100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 100 mg QW Breast Cancer
n=5 Participants
Participants received 100 mg of LY3022855 administered IV once weekly (QW) of a 6-week cycle.
|
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer
n=7 Participants
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer
n=4 Participants
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
|
|---|---|---|---|---|---|---|
|
Serum Cytokine Levels
CSF-1
|
308460 nanograms per liter (ng/L)
Interval 182347.5 to 358665.0
|
23564.3 nanograms per liter (ng/L)
Interval 511.4 to 70952.5
|
290520 nanograms per liter (ng/L)
Interval 792.8 to 328780.0
|
470350 nanograms per liter (ng/L)
Interval 335340.0 to 472700.0
|
235950 nanograms per liter (ng/L)
Interval 67192.0 to 247580.0
|
159550 nanograms per liter (ng/L)
Interval 81224.5 to 211830.0
|
|
Serum Cytokine Levels
IL-34
|
670.6 nanograms per liter (ng/L)
Interval 425.75 to 766.08
|
137.56 nanograms per liter (ng/L)
Interval 62.5 to 257.73
|
498.89 nanograms per liter (ng/L)
Interval 62.5 to 637.28
|
447.11 nanograms per liter (ng/L)
Interval 357.36 to 737.66
|
392.54 nanograms per liter (ng/L)
Interval 145.57 to 517.92
|
123.44 nanograms per liter (ng/L)
Interval 106.27 to 167.87
|
SECONDARY outcome
Timeframe: 0, 1, 4, 24, 48, 72 and 168 hours post dose on Day 1 and Day 29Population: All enrolled participants who received at least one dose of study drug and have evaluable PK data for AUC.
Area under the concentration versus time curve from time zero to tau (τ) of LY3022855 (AUC\[0- τ\]), where tau is dosing interval of (0-14 days).
Outcome measures
| Measure |
LY3022855 - 1.25 mg/kg Q2W Breast Cancer
n=6 Participants
Participants received 1.25 milligram per kilogram (mg/kg) of LY3022855 administered intravenously (IV) once every two weeks (Q2W) of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer
n=5 Participants
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
|
LY3022855 - 100 mg Q2W Breast Cancer
n=4 Participants
Participants received 100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 100 mg QW Breast Cancer
n=2 Participants
Participants received 100 mg of LY3022855 administered IV once weekly (QW) of a 6-week cycle.
|
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Curve of LY3022855
Day 1
|
1950 hours*micrograms/mL
Geometric Coefficient of Variation 35
|
1030 hours*micrograms/mL
Geometric Coefficient of Variation 38
|
4310 hours*micrograms/mL
Geometric Coefficient of Variation 14
|
2350 hours*micrograms/mL
Geometric Coefficient of Variation 31
|
—
|
—
|
|
Pharmacokinetics (PK): Area Under the Concentration Curve of LY3022855
Day 29
|
2260 hours*micrograms/mL
Geometric Coefficient of Variation 61
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 6 cycles (cycle = 6 weeks)Population: All enrolled participants who received at least one dose of study drug and have baseline and post-baseline data for disease control rate.
Disease control rate is the percentage of participants with a confirmed CR, PR or SD, as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion; SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Disease control rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.
Outcome measures
| Measure |
LY3022855 - 1.25 mg/kg Q2W Breast Cancer
n=6 Participants
Participants received 1.25 milligram per kilogram (mg/kg) of LY3022855 administered intravenously (IV) once every two weeks (Q2W) of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer
n=5 Participants
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
|
LY3022855 - 100 mg Q2W Breast Cancer
n=5 Participants
Participants received 100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 100 mg QW Breast Cancer
n=6 Participants
Participants received 100 mg of LY3022855 administered IV once weekly (QW) of a 6-week cycle.
|
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer
n=8 Participants
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer
n=4 Participants
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate)
|
50 Percentage of Participants
Interval 15.3 to 84.7
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
20 Percentage of Participants
Interval 1.0 to 65.7
|
16.7 Percentage of Participants
Interval 0.9 to 58.2
|
37.5 Percentage of Participants
Interval 11.1 to 71.1
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
Adverse Events
LY3022855 - 1.25 mg/kg Q2W Breast Cancer
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
LY3022855 - 100 mg Q2W Breast Cancer
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
LY3022855 - 100 mg QW Breast Cancer
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY3022855 - 1.25 mg/kg Q2W Breast Cancer
n=6 participants at risk
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer
n=5 participants at risk
Participants received 1.0 mg/kg of LY3022855 administered IV on weeks 1, 2, 4, and 5 of a 6-week cycle.
|
LY3022855 - 100 mg Q2W Breast Cancer
n=5 participants at risk
Participants received 100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 100 mg QW Breast Cancer
n=6 participants at risk
Participants received 100 mg of LY3022855 administered IV once weekly of a 6-week cycle.
|
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer
n=8 participants at risk
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer
n=4 participants at risk
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks 1, 2, 4, and 5 of a 6-week cycle.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Cardiomyopathy
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Chest pain
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Disease complication
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Infection
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Encephalopathy
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Confusional state
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
Other adverse events
| Measure |
LY3022855 - 1.25 mg/kg Q2W Breast Cancer
n=6 participants at risk
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer
n=5 participants at risk
Participants received 1.0 mg/kg of LY3022855 administered IV on weeks 1, 2, 4, and 5 of a 6-week cycle.
|
LY3022855 - 100 mg Q2W Breast Cancer
n=5 participants at risk
Participants received 100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 100 mg QW Breast Cancer
n=6 participants at risk
Participants received 100 mg of LY3022855 administered IV once weekly of a 6-week cycle.
|
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer
n=8 participants at risk
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
|
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer
n=4 participants at risk
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks 1, 2, 4, and 5 of a 6-week cycle.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
50.0%
3/6 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
2/8 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
2/8 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
2/8 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Dry eye
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Eye oedema
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Eye swelling
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Periorbital oedema
|
50.0%
3/6 • Number of events 4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
62.5%
5/8 • Number of events 6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
37.5%
3/8 • Number of events 4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
60.0%
3/5 • Number of events 6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
60.0%
3/5 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
37.5%
3/8 • Number of events 4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
50.0%
2/4 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Chest pain
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
60.0%
3/5 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
60.0%
3/5 • Number of events 4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
50.0%
3/6 • Number of events 4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
87.5%
7/8 • Number of events 10 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
50.0%
2/4 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
50.0%
4/8 • Number of events 5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • Number of events 4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Amylase increased
|
16.7%
1/6 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6 • Number of events 8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • Number of events 4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
16.7%
1/6 • Number of events 5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 7 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
50.0%
3/6 • Number of events 6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
2/8 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Gamma-glutamyltransferase increased
|
33.3%
2/6 • Number of events 5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Lipase increased
|
33.3%
2/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
60.0%
3/5 • Number of events 7 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Prostatic specific antigen increased
|
—
0/0 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
—
0/0 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
—
0/0 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Weight decreased
|
33.3%
2/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
3/6 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
50.0%
4/8 • Number of events 5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
50.0%
2/4 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
50.0%
2/4 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
2/8 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Breast disorder
|
16.7%
1/6 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Breast mass
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Breast pain
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
—
0/0 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
—
0/0 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
80.0%
4/5 • Number of events 5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
37.5%
3/8 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 3 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
1/6 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 2 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 133 Weeks
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60