Trial Outcomes & Findings for Safety and Efficacy of LCI699 in Cushing's Disease Patients (NCT NCT01331239)
NCT ID: NCT01331239
Last Updated: 2021-01-22
Results Overview
A patient was considered to be a responder if his/her mean UFC level from the three 24-hour urine samples collected at Week 10 was ≤ Upper Limit of Normal (ULN), as defined by the local laboratories, or represented a ≥50% decrease from baseline. Patients who discontinued for a disease or treatment related reason (e.g. death, adverse event, clinical disease progression etc.), or whose mean Week 10 24-hour UFC levels were higher than the normal limit and experienced \<50% decrease in UFC were classified as non-responders.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
10 weeks
Results posted on
2021-01-22
Participant Flow
31 were enrolled in the study: 12 in Part l and 19 in Part ll Core. Four of the participants in the Part II Core were previously enrolled in the Part I Core. That is, 4 participants who were included in Part 1 as well as in Part 2, re-enrolled in the study in part 2 (i.e., they completed the informed consent process again in Part 2, and were considered re-enrolled, after originally enrolling in part 1).
For overall study: 27 patients were planned; For Part l of the study, 12 - 15 patients were planned to be enrolled. For Part ll Core 19 patients were planned to be enrolled.
Participant milestones
| Measure |
Part l: Core Cohort
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part II Core: Expansion Cohort
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Expansion of this study. These patients were all newly enrolled into the phase ll part of the study.
|
Part ll Core: Follow-up Cohort
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
|---|---|---|---|
|
Part I: Core Study
STARTED
|
12
|
0
|
0
|
|
Part I: Core Study
COMPLETED
|
12
|
0
|
0
|
|
Part I: Core Study
NOT COMPLETED
|
0
|
0
|
0
|
|
Part II: Core Study
STARTED
|
0
|
15
|
4
|
|
Part II: Core Study
COMPLETED
|
0
|
7
|
3
|
|
Part II: Core Study
NOT COMPLETED
|
0
|
8
|
1
|
Reasons for withdrawal
| Measure |
Part l: Core Cohort
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part II Core: Expansion Cohort
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Expansion of this study. These patients were all newly enrolled into the phase ll part of the study.
|
Part ll Core: Follow-up Cohort
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
|---|---|---|---|
|
Part II: Core Study
Adverse Event
|
0
|
3
|
0
|
|
Part II: Core Study
Subj's cond. no longer require treatment
|
0
|
2
|
1
|
|
Part II: Core Study
Withdrawal by Subject
|
0
|
2
|
0
|
|
Part II: Core Study
Administrative problems
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of LCI699 in Cushing's Disease Patients
Baseline characteristics by cohort
| Measure |
Part l: Core Cohort
n=12 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part II Core: Expansion Cohort
n=15 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Expansion of this study. These patients were all newly enrolled into the phase ll part of the study.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 years
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: Primary Analysis Set: All patients with evaluable UFC data (at least two 24 hour measurements for both baseline and Week 10) were included in the primary efficacy analysis set. Of the 12 patients enrolled to this arm, 9 of the 12 patients met this criteria.
A patient was considered to be a responder if his/her mean UFC level from the three 24-hour urine samples collected at Week 10 was ≤ Upper Limit of Normal (ULN), as defined by the local laboratories, or represented a ≥50% decrease from baseline. Patients who discontinued for a disease or treatment related reason (e.g. death, adverse event, clinical disease progression etc.), or whose mean Week 10 24-hour UFC levels were higher than the normal limit and experienced \<50% decrease in UFC were classified as non-responders.
Outcome measures
| Measure |
Part l: Core Cohort
n=9 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Percentage of Responders to LCI699 Based on the Change in Mean Urinary Free Cortisol (UFC) From Baseline to Week 10
|
100.0 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline, Week 22, Week 70, Last observed value (LOV), up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core proof of concept (PoC) follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04.
Change in Deoxycorticosterone over time.
Outcome measures
| Measure |
Part l: Core Cohort
n=15 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=4 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From Baseline (BL) in Steroid Hormones of Hypothalamic-Pituitary-Adrenal (HPA)-Axis: 11- Deoxycorticosterone (Overall)
BL: 11-Deoxycorticosterone
|
292.8 pmol/L
Standard Deviation 371.54
|
188.0 pmol/L
Standard Deviation 105.21
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of Hypothalamic-Pituitary-Adrenal (HPA)-Axis: 11- Deoxycorticosterone (Overall)
WK 22: 11-Deoxycorticosterone
|
6957.8 pmol/L
Standard Deviation 9627.77
|
3670.0 pmol/L
Standard Deviation 2734.34
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of Hypothalamic-Pituitary-Adrenal (HPA)-Axis: 11- Deoxycorticosterone (Overall)
WK 70: 11-Deoxycorticosterone
|
2523.1 pmol/L
Standard Deviation 1597.39
|
1743.0 pmol/L
Standard Deviation 1048.22
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of Hypothalamic-Pituitary-Adrenal (HPA)-Axis: 11- Deoxycorticosterone (Overall)
LOV: 11-Deoxycorticosterone
|
1640.8 pmol/L
Standard Deviation 2097.16
|
1822.3 pmol/L
Standard Deviation 1452.72
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline, Week 22, Week 70, Last observed value (LOV), up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04.
Change in Deoxycortisol over time.
Outcome measures
| Measure |
Part l: Core Cohort
n=15 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=4 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: 11-Deoxycortisol (Overall)
BL: 11-Deoxycortisol
|
4.21 nmol/L
Standard Deviation 4.648
|
5.48 nmol/L
Standard Deviation 6.549
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: 11-Deoxycortisol (Overall)
WK 22: 11-Deoxycortisol
|
45.48 nmol/L
Standard Deviation 44.880
|
54.75 nmol/L
Standard Deviation 60.676
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: 11-Deoxycortisol (Overall)
WK 70: 11-Deoxycortisol
|
15.32 nmol/L
Standard Deviation 13.463
|
9.03 nmol/L
Standard Deviation 7.934
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: 11-Deoxycortisol (Overall)
LOV: 11-Deoxycortisol
|
8.60 nmol/L
Standard Deviation 18.910
|
11.83 nmol/L
Standard Deviation 19.101
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline, Week 22, Week 70, Last observed value (LOV), up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04.
Change in aldosterone \& thyroxine, free over time.
Outcome measures
| Measure |
Part l: Core Cohort
n=15 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=4 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Aldosterone, Thyroxine, Free (T4)
BL: Aldosterone
|
165.5 pmol/L
Standard Deviation 255.07
|
127.0 pmol/L
Standard Deviation 177.04
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Aldosterone, Thyroxine, Free (T4)
WK 22: Aldosterone
|
-151.1 pmol/L
Standard Deviation 290.53
|
-64.5 pmol/L
Standard Deviation 247.93
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Aldosterone, Thyroxine, Free (T4)
WK 70: Aldosterone
|
-101.9 pmol/L
Standard Deviation 153.82
|
-120.0 pmol/L
Standard Deviation 182.11
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Aldosterone, Thyroxine, Free (T4)
LOV: Aldosterone
|
-135.1 pmol/L
Standard Deviation 258.36
|
-99.5 pmol/L
Standard Deviation 149.06
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Aldosterone, Thyroxine, Free (T4)
BL: Thyroxine, free
|
14.02 pmol/L
Standard Deviation 3.233
|
18.40 pmol/L
Standard Deviation 8.050
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Aldosterone, Thyroxine, Free (T4)
WK 22: Thyroxine, free
|
-1.17 pmol/L
Standard Deviation 3.254
|
-3.63 pmol/L
Standard Deviation 3.247
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Aldosterone, Thyroxine, Free (T4)
WK 70: Thyroxine, free
|
0.46 pmol/L
Standard Deviation 2.355
|
-3.78 pmol/L
Standard Deviation 7.951
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Aldosterone, Thyroxine, Free (T4)
LOV: Thyroxine, free
|
1.69 pmol/L
Standard Deviation 3.281
|
-2.33 pmol/L
Standard Deviation 5.324
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline, Week 22, Week 70, Last observed value (LOV), up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04. This analysis was on the female patients only.
Change in Estradiol in females over time.
Outcome measures
| Measure |
Part l: Core Cohort
n=11 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=3 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Estradiol (Female)
BL: Female Estradiol
|
209.60 pmol/L
Standard Deviation 282.423
|
307.23 pmol/L
Standard Deviation 263.028
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Estradiol (Female)
WK 22: Female Estradiol
|
-42.19 pmol/L
Standard Deviation 223.444
|
-24.63 pmol/L
Standard Deviation 234.288
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Estradiol (Female)
WK 70: Female Estradiol
|
10.55 pmol/L
Standard Deviation 187.443
|
-141.00 pmol/L
Standard Deviation 376.080
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Estradiol (Female)
LOV: Female Estradiol
|
-114.24 pmol/L
Standard Deviation 305.334
|
666.93 pmol/L
Standard Deviation 1108.794
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline, Week 22, Week 70, Last observed value (LOV), up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04. This analysis was on the male patients only.
Change in Estradiol in males over time.
Outcome measures
| Measure |
Part l: Core Cohort
n=4 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=1 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Estradiol (Male)
BL: Male Estradiol
|
55.00 pmol/L
Standard Deviation 25.755
|
77.10 pmol/L
Standard Deviation NA
NA: Standard Deviation (SD) could not be calculated as there was only 1 patient.
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Estradiol (Male)
WK 22: Male Estradiol
|
35.00 pmol/L
Standard Deviation 68.005
|
18.30 pmol/L
Standard Deviation NA
NA: SD could not be calculated as there was only 1 patient.
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Estradiol (Male)
WK 70: Male Estradiol
|
-1.00 pmol/L
Standard Deviation 16.523
|
110.10 pmol/L
Standard Deviation NA
NA: SD could not be calculated as there was only 1 patient.
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Estradiol (Male)
LOV: Male Estradiol
|
2.50 pmol/L
Standard Deviation 55.729
|
-33.10 pmol/L
Standard Deviation NA
NA: SD could not be calculated as there was only 1 patient.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline, Week 22, Week 70, Last observed value (LOV), up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04. This analysis was on the female patients only.
Change in FSH in females over time.
Outcome measures
| Measure |
Part l: Core Cohort
n=11 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=3 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Follicle Stimulation Hormone (FSH) (Female)
BL: Female FSH
|
9.09 U/L
Standard Deviation 13.277
|
2.43 U/L
Standard Deviation 0.929
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Follicle Stimulation Hormone (FSH) (Female)
WK 22: Female FSH
|
14.89 U/L
Standard Deviation 28.673
|
2.90 U/L
Standard Deviation 2.476
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Follicle Stimulation Hormone (FSH) (Female)
WK 70: Female FSH
|
3.58 U/L
Standard Deviation 14.021
|
3.20 U/L
Standard Deviation 2.081
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Follicle Stimulation Hormone (FSH) (Female)
LOV: Female FSH
|
15.41 U/L
Standard Deviation 23.613
|
3.70 U/L
Standard Deviation 2.524
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline, Week 22, Week 70, Last observed value (LOV), up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04. This analysis was on the male patients only.
Change in FSH in males over time.
Outcome measures
| Measure |
Part l: Core Cohort
n=4 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=1 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Follicle Stimulation Hormone (Male)
BL: Male FSH
|
5.88 U/L
Standard Deviation 3.241
|
5.80 U/L
Standard Deviation NA
NA: SD could not be calculated as there was only 1 patient.
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Follicle Stimulation Hormone (Male)
WK 22: Male FSH
|
-1.20 U/L
Standard Deviation 1.560
|
-5.20 U/L
Standard Deviation NA
NA: SD could not be calculated as there was only 1 patient.
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Follicle Stimulation Hormone (Male)
WK 70: Male FSH
|
-1.80 U/L
Standard Deviation 1.735
|
-5.80 U/L
Standard Deviation NA
NA: SD could not be calculated as there was only 1 patient.
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Follicle Stimulation Hormone (Male)
LOV: Male FSH
|
-1.38 U/L
Standard Deviation 5.660
|
-2.90 U/L
Standard Deviation NA
NA: SD could not be calculated as there was only 1 patient.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline, Week 22, Week 70, Last observed value (LOV), up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04.
Change in Renin, Insulin \& Thyrotropin over time.
Outcome measures
| Measure |
Part l: Core Cohort
n=15 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=4 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Renin, Insulin, Thyrotropin
BL: Renin
|
23.706 mU/L
Standard Deviation 18.0642
|
73.973 mU/L
Standard Deviation 102.338
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Renin, Insulin, Thyrotropin
WK 22: Renin
|
45.899 mU/L
Standard Deviation 144.9575
|
-16.838 mU/L
Standard Deviation 145.6609
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Renin, Insulin, Thyrotropin
WK 70: Renin
|
70.051 mU/L
Standard Deviation 117.9931
|
-55.638 mU/L
Standard Deviation 88.9155
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Renin, Insulin, Thyrotropin
LOV: Renin
|
24.209 mU/L
Standard Deviation 52.0438
|
-43.718 mU/L
Standard Deviation 70.5958
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Renin, Insulin, Thyrotropin
BL: Insulin
|
25.61 mU/L
Standard Deviation 27.166
|
22.38 mU/L
Standard Deviation 7.071
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Renin, Insulin, Thyrotropin
WK 22: Insulin
|
-10.63 mU/L
Standard Deviation 20.247
|
-8.58 mU/L
Standard Deviation 4.456
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Renin, Insulin, Thyrotropin
WK 70: Insulin
|
-8.69 mU/L
Standard Deviation 24.132
|
-12.53 mU/L
Standard Deviation 8.772
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Renin, Insulin, Thyrotropin
LOV: Insulin
|
-8.11 mU/L
Standard Deviation 23.169
|
-5.78 mU/L
Standard Deviation 11.771
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Renin, Insulin, Thyrotropin
BL: Thyrotropin
|
0.659 mU/L
Standard Deviation 0.6827
|
0.815 mU/L
Standard Deviation 0.8364
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Renin, Insulin, Thyrotropin
WK 22: Thyrotropin
|
1.445 mU/L
Standard Deviation 2.3295
|
0.280 mU/L
Standard Deviation 0.3118
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Renin, Insulin, Thyrotropin
WK 70: Thyrotropin
|
2.387 mU/L
Standard Deviation 4.0991
|
0.395 mU/L
Standard Deviation 0.4674
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Renin, Insulin, Thyrotropin
LOV: Thyrotropin
|
1.244 mU/L
Standard Deviation 3.4627
|
0.885 mU/L
Standard Deviation 0.5994
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline, Week 22, Week 70, Last observed value (LOV), up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04.
Change in Insulin-like Growth Factor-1 over time.
Outcome measures
| Measure |
Part l: Core Cohort
n=15 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=4 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Insulin-like Growth Factor-1
BL: Insulin-like Growth Factor-1
|
157.56 ug/L
Standard Deviation 109.044
|
235.30 ug/L
Standard Deviation 110.249
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Insulin-like Growth Factor-1
WK 22: Insulin-like Growth Factor-1
|
-9.78 ug/L
Standard Deviation 67.387
|
-35.20 ug/L
Standard Deviation 153.817
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Insulin-like Growth Factor-1
WK 70: Insulin-like Growth Factor-1
|
-41.23 ug/L
Standard Deviation 76.969
|
-113.43 ug/L
Standard Deviation 86.529
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Insulin-like Growth Factor-1
LOV: Insulin-like Growth Factor-1
|
-56.76 ug/L
Standard Deviation 105.936
|
-46.07 ug/L
Standard Deviation 62.155
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline, Week 22, Week 70, Last observed value (LOV), up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04. This analysis was on the female patients only.
Change in LH in females over time.
Outcome measures
| Measure |
Part l: Core Cohort
n=11 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=3 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Luteinising Hormone (LH) (Female)
BL: Female LH
|
2.78 U/L
Standard Deviation 2.220
|
1.00 U/L
Standard Deviation 1.000
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Luteinising Hormone (LH) (Female)
WK 22: Female LH
|
7.45 U/L
Standard Deviation 17.051
|
4.40 U/L
Standard Deviation 0.990
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Luteinising Hormone (LH) (Female)
WK 70: Female LH
|
7.47 U/L
Standard Deviation 15.267
|
2.63 U/L
Standard Deviation 3.235
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Luteinising Hormone (LH) (Female)
LOV: Female LH
|
7.30 U/L
Standard Deviation 10.885
|
3.37 U/L
Standard Deviation 2.060
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline, Week 22, Week 70, Last observed value (LOV), up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04. This analysis was on the male patients only.
Change in LH in males over time.
Outcome measures
| Measure |
Part l: Core Cohort
n=4 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=1 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: LH (Male)
BL: Male LH
|
2.48 U/L
Standard Deviation 1.328
|
5.90 U/L
Standard Deviation NA
NA: SD could not be calculated as there was only 1 patient.
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: LH (Male)
WK 22: Male LH
|
0.48 U/L
Standard Deviation 1.081
|
-5.70 U/L
Standard Deviation NA
NA: SD could not be calculated as there was only 1 patient.
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: LH (Male)
WK 70: Male LH
|
-0.53 U/L
Standard Deviation 1.021
|
-5.90 U/L
Standard Deviation NA
NA: SD could not be calculated as there was only 1 patient.
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: LH (Male)
LOV: Male LH
|
-0.05 U/L
Standard Deviation 2.610
|
-2.70 U/L
Standard Deviation NA
NA: SD could not be calculated as there was only 1 patient.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline, Week 22, Week 70, Last observed value (LOV), up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04. This analysis was on the female patients only.
Change in Testosterone in females over time.
Outcome measures
| Measure |
Part l: Core Cohort
n=11 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=3 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Testosterone (Female)
BL: Female Testosterone
|
1.18 nmol/L
Standard Deviation 0.820
|
1.43 nmol/L
Standard Deviation 0.404
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Testosterone (Female)
WK 22: Female Testosterone
|
1.85 nmol/L
Standard Deviation 1.790
|
5.27 nmol/L
Standard Deviation 5.353
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Testosterone (Female)
WK 70: Female Testosterone
|
0.53 nmol/L
Standard Deviation 1.409
|
0.50 nmol/L
Standard Deviation 1.400
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Testosterone (Female)
LOV: Female Testosterone
|
0.25 nmol/L
Standard Deviation 1.532
|
0.17 nmol/L
Standard Deviation 1.266
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline, Week 22, Week 70, Last observed value (LOV), up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04. This analysis was on the male patients only.
Change in Testosterone in males over time.
Outcome measures
| Measure |
Part l: Core Cohort
n=4 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=1 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Testosterone (Male)
BL: Male Testosterone
|
7.53 nmol/L
Standard Deviation 4.076
|
7.10 nmol/L
Standard Deviation NA
NA: SD could not be calculated as there was only 1 patient.
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Testosterone (Male)
WK 22: Male Testosterone
|
6.55 nmol/L
Standard Deviation 4.751
|
2.40 nmol/L
Standard Deviation NA
NA: SD could not be calculated as there was only 1 patient.
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Testosterone (Male)
WK 70: Male Testosterone
|
5.17 nmol/L
Standard Deviation 1.504
|
32.60 nmol/L
Standard Deviation NA
NA: SD could not be calculated as there was only 1 patient.
|
—
|
—
|
—
|
|
Actual Change From Baseline (BL) in Steroid Hormones of HPA-axis: Testosterone (Male)
LOV: Male Testosterone
|
8.15 nmol/L
Standard Deviation 7.859
|
0.00 nmol/L
Standard Deviation NA
NA: SD could not be calculated as there was only 1 patient.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 22, Week 70, Last observed value, up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04.
Improving metabolic abnormalities was assessed by descriptive statistics on the change from baseline.
Outcome measures
| Measure |
Part l: Core Cohort
n=15 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=4 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Fasting Glucose
BL
|
108.1 mg/dL
Standard Deviation 55.12
|
96.3 mg/dL
Standard Deviation 14.43
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Fasting Glucose
WK 22
|
-14.5 mg/dL
Standard Deviation 32.45
|
-16.3 mg/dL
Standard Deviation 14.93
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Fasting Glucose
WK 70
|
-22.5 mg/dL
Standard Deviation 36.87
|
-20.8 mg/dL
Standard Deviation 24.62
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Fasting Glucose
LOV
|
-17.9 mg/dL
Standard Deviation 35.99
|
-13.8 mg/dL
Standard Deviation 22.88
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 22, Week 70, Last observed value, up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04.
Improving metabolic abnormalities was assessed by descriptive statistics on the change from baseline.
Outcome measures
| Measure |
Part l: Core Cohort
n=15 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=4 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Hemoglobin A1C (HbA1C) (Glycosylated Hemoglobin)
BL
|
5.7 Percentage
Standard Deviation 0.77
|
6.0 Percentage
Standard Deviation 0.61
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Hemoglobin A1C (HbA1C) (Glycosylated Hemoglobin)
WK 22
|
-0.1 Percentage
Standard Deviation 0.27
|
-0.3 Percentage
Standard Deviation 0.28
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Hemoglobin A1C (HbA1C) (Glycosylated Hemoglobin)
WK 70
|
-0.1 Percentage
Standard Deviation 0.43
|
-0.6 Percentage
Standard Deviation 0.74
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Hemoglobin A1C (HbA1C) (Glycosylated Hemoglobin)
LOV
|
-0.1 Percentage
Standard Deviation 0.56
|
-0.4 Percentage
Standard Deviation 0.49
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 22, Week 70, Last observed value, up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04.
Improving metabolic abnormalities was assessed by descriptive statistics on the change from baseline.
Outcome measures
| Measure |
Part l: Core Cohort
n=15 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=4 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides
BL Cholesterol
|
5.2 mmo1/L
Standard Deviation 1.36
|
5.7 mmo1/L
Standard Deviation 1.44
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides
WK 22 Cholesterol
|
-0.7 mmo1/L
Standard Deviation 1.58
|
-0.5 mmo1/L
Standard Deviation 0.56
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides
WK 70 Cholesterol
|
-0.1 mmo1/L
Standard Deviation 1.35
|
-1.2 mmo1/L
Standard Deviation 1.74
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides
LOV Cholesterol
|
0.5 mmo1/L
Standard Deviation 2.39
|
1.5 mmo1/L
Standard Deviation 5.22
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides
BL LDL Cholesterol
|
3.0 mmo1/L
Standard Deviation 1.32
|
4.8 mmo1/L
Standard Deviation 2.31
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides
WK 22 LDL Cholesterol
|
-0.3 mmo1/L
Standard Deviation 1.35
|
-1.5 mmo1/L
Standard Deviation 1.98
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides
WK 70 LDL Cholesterol
|
0.0 mmo1/L
Standard Deviation 1.17
|
-2.2 mmo1/L
Standard Deviation 2.11
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides
LOV LDL Cholesterol
|
0.3 mmo1/L
Standard Deviation 1.58
|
-0.7 mmo1/L
Standard Deviation 1.83
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides
BL HDL Cholesterol
|
1.6 mmo1/L
Standard Deviation 0.39
|
2.1 mmo1/L
Standard Deviation 1.85
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides
WK 22 HDL Cholesterol
|
-0.3 mmo1/L
Standard Deviation 0.32
|
-0.9 mmo1/L
Standard Deviation 1.58
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides
WK 70 HDL Cholesterol
|
-0.3 mmo1/L
Standard Deviation 0.42
|
-0.9 mmo1/L
Standard Deviation 1.60
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides
LOV HDL Cholesterol
|
0.1 mmo1/L
Standard Deviation 0.66
|
-0.0 mmo1/L
Standard Deviation 0.49
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides
BL Triglycerides
|
1.5 mmo1/L
Standard Deviation 0.70
|
1.4 mmo1/L
Standard Deviation 0.32
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides
WK 22 Triglycerides
|
-0.1 mmo1/L
Standard Deviation 0.42
|
0.1 mmo1/L
Standard Deviation 0.49
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides
WK 70 Triglycerides
|
0.3 mmo1/L
Standard Deviation 0.76
|
-0.2 mmo1/L
Standard Deviation 0.25
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides
LOV Triglycerides
|
0.1 mmo1/L
Standard Deviation 0.64
|
-0.1 mmo1/L
Standard Deviation 0.54
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 22, Week 70, Last observed value, up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04.
Improving metabolic abnormalities was assessed by descriptive statistics on the change from baseline.
Outcome measures
| Measure |
Part l: Core Cohort
n=15 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=4 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Sitting Diastolic Blood Pressure (DBP), Sitting Systolic Blood Pressure (SBP)
BL DBP
|
84.5 mmHG
Standard Deviation 7.01
|
87.3 mmHG
Standard Deviation 4.21
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Sitting Diastolic Blood Pressure (DBP), Sitting Systolic Blood Pressure (SBP)
WK 22 DPB
|
0.8 mmHG
Standard Deviation 9.59
|
2.6 mmHG
Standard Deviation 11.36
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Sitting Diastolic Blood Pressure (DBP), Sitting Systolic Blood Pressure (SBP)
WK 70 DPB
|
-3.4 mmHG
Standard Deviation 11.65
|
-5.8 mmHG
Standard Deviation 12.14
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Sitting Diastolic Blood Pressure (DBP), Sitting Systolic Blood Pressure (SBP)
LOV DPB
|
-1.3 mmHG
Standard Deviation 9.23
|
-3.2 mmHG
Standard Deviation 7.07
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Sitting Diastolic Blood Pressure (DBP), Sitting Systolic Blood Pressure (SBP)
BL SBP
|
133.2 mmHG
Standard Deviation 12.51
|
130.3 mmHG
Standard Deviation 7.75
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Sitting Diastolic Blood Pressure (DBP), Sitting Systolic Blood Pressure (SBP)
WK 22 SPB
|
-4.0 mmHG
Standard Deviation 12.46
|
8.8 mmHG
Standard Deviation 24.74
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Sitting Diastolic Blood Pressure (DBP), Sitting Systolic Blood Pressure (SBP)
WK 70 SPB
|
-9.5 mmHG
Standard Deviation 15.78
|
-4.7 mmHG
Standard Deviation 26.09
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Sitting Diastolic Blood Pressure (DBP), Sitting Systolic Blood Pressure (SBP)
LOV SPB
|
-6.2 mmHG
Standard Deviation 16.50
|
0.3 mmHG
Standard Deviation 20.60
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 22, Week 70, Last observed value, up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04.
Improving metabolic abnormalities was assessed by descriptive statistics on the change from baseline.
Outcome measures
| Measure |
Part l: Core Cohort
n=15 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=4 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Weight
BL
|
85.4 Kg
Standard Deviation 23.52
|
84.0 Kg
Standard Deviation 23.32
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Weight
WK 22
|
-2.1 Kg
Standard Deviation 4.02
|
0.6 Kg
Standard Deviation 2.64
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Weight
WK 70
|
-5.2 Kg
Standard Deviation 4.56
|
-3.2 Kg
Standard Deviation 5.61
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Weight
LOV
|
-4.5 Kg
Standard Deviation 6.68
|
-4.4 Kg
Standard Deviation 7.00
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 22, Week 70, Last observed value, up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04.
Improving metabolic abnormalities was assessed by descriptive statistics on the change from baseline.
Outcome measures
| Measure |
Part l: Core Cohort
n=15 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=4 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Body Mass Index (BMI)
BL
|
30.6 Kg/m^2
Standard Deviation 7.46
|
31.3 Kg/m^2
Standard Deviation 5.49
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Body Mass Index (BMI)
WK 22
|
-0.7 Kg/m^2
Standard Deviation 1.42
|
0.2 Kg/m^2
Standard Deviation 1.09
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Body Mass Index (BMI)
WK 70
|
-1.9 Kg/m^2
Standard Deviation 1.93
|
-1.4 Kg/m^2
Standard Deviation 2.25
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Body Mass Index (BMI)
LOV
|
-1.6 Kg/m^2
Standard Deviation 2.73
|
-2.0 Kg/m^2
Standard Deviation 2.73
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 22, Week 70, Last observed value, up to Month 88Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04.
Improving metabolic abnormalities was assessed by descriptive statistics on the change from baseline. QUICKI is the quantitative insulin sensitivity check index and is derived using the inverse of the sum of algorithms (base 10) of the fasting insulin and fasting glucose: 1/(log(fasting insulin mU/mL)+log(fasting glucose mg/dL)). Values typically associated with the QUICKI calculation for insulin resistance in humans fall broadly within a range between 0.45 for unusually healthy individuals and 0.30 in diabetics. So lower numbers reflect greater insulin resistance.
Outcome measures
| Measure |
Part l: Core Cohort
n=15 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=4 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Quantitative Insulin Sensitivity Check Index (QUICKI)
BL
|
0.3 unitless
Standard Deviation 0.03
|
0.3 unitless
Standard Deviation 0.02
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Quantitative Insulin Sensitivity Check Index (QUICKI)
WK 22
|
0.0 unitless
Standard Deviation 0.02
|
0.0 unitless
Standard Deviation 0.01
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Quantitative Insulin Sensitivity Check Index (QUICKI)
WK 70
|
0.0 unitless
Standard Deviation 0.03
|
0.0 unitless
Standard Deviation 0.06
|
—
|
—
|
—
|
|
Actual Change From BL in Cardiovascular and Other Metabolic Parameters: Quantitative Insulin Sensitivity Check Index (QUICKI)
LOV
|
0.0 unitless
Standard Deviation 0.04
|
0.0 unitless
Standard Deviation 0.04
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose (0 hour), 1, 1.5, 2, 4 and 6 hours post AM dose for escalation dose or pre-dose (trough) for maintained dosePopulation: Pharmacokinetic Analysis Set (PAS): all enrolled patients with at least 1 dose of study drug and at least 1 post-dose PK assessment after Protocol Amendment 4 or after re-entering the study.
Trough PK concentrations and PK profiles at steady-state were collected. The AUC from time 0 to 12 h post dose at steady state, calculated by using the predose concentration (Ctrough,ss) as the 12 h concentration, assuming steady-state has been reached.
Outcome measures
| Measure |
Part l: Core Cohort
n=4 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=13 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
n=6 Participants
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
n=1 Participants
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
n=1 Participants
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK) Parameters: Area Under Curve (AUC)0-6h ss, AUC0-12h ss
AUC0-6h,ss
|
37.79 hr•ng/mL
Geometric Coefficient of Variation 42.7
|
94.21 hr•ng/mL
Geometric Coefficient of Variation 37.0
|
236.83 hr•ng/mL
Geometric Coefficient of Variation 29.9
|
NA hr•ng/mL
Geometric Coefficient of Variation NA
NA: geo-mean/coefficient variation (CV) geo-mean could not be calculated as only 1 patient
|
NA hr•ng/mL
Geometric Coefficient of Variation NA
NA: geo-mean/CV geo-mean could not be calculated as only 1 patient
|
|
Pharmacokinetics (PK) Parameters: Area Under Curve (AUC)0-6h ss, AUC0-12h ss
AUC0-12h,ss
|
69.96 hr•ng/mL
Geometric Coefficient of Variation 32.6
|
140.65 hr•ng/mL
Geometric Coefficient of Variation 43.9
|
339.62 hr•ng/mL
Geometric Coefficient of Variation 37.6
|
NA hr•ng/mL
Geometric Coefficient of Variation NA
NA: geo-mean/CV geo-mean could not be calculated as only 1 patient
|
NA hr•ng/mL
Geometric Coefficient of Variation NA
NA: geo-mean/CV geo-mean could not be calculated as only 1 patient
|
SECONDARY outcome
Timeframe: pre-dose (0 hour), 1, 1.5, 2, 4 and 6 hours post AM dose for escalation dose or pre-dose (trough) for maintained dosePopulation: PAS: all enrolled patients with at least 1 dose of study drug and at least 1 post-dose PK assessment after Protocol Amendment 4 or after re-entering the study.
Trough PK concentrations and PK profiles at steady-state were collected.
Outcome measures
| Measure |
Part l: Core Cohort
n=6 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=14 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
n=8 Participants
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
n=2 Participants
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
n=1 Participants
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
PK Parameters: Cmax ss, Ctrough ss
Cmax,ss
|
8.76 ng/mL
Geometric Coefficient of Variation 46.1
|
23.09 ng/mL
Geometric Coefficient of Variation 31.5
|
59.17 ng/mL
Geometric Coefficient of Variation 25.5
|
NA ng/mL
Geometric Coefficient of Variation NA
NA: geo-mean/CV geo-mean could not be calculated as only 1 patient
|
NA ng/mL
Geometric Coefficient of Variation NA
NA: geo-mean/CV geo-mean could not be calculated as only 1 patient
|
|
PK Parameters: Cmax ss, Ctrough ss
Ctrough, ss
|
2.73 ng/mL
Geometric Coefficient of Variation 49.1
|
4.30 ng/mL
Geometric Coefficient of Variation 112.9
|
10.60 ng/mL
Geometric Coefficient of Variation 104.8
|
19.69 ng/mL
Geometric Coefficient of Variation 53.6
|
NA ng/mL
Geometric Coefficient of Variation NA
NA: geo-mean/CV geo-mean could not be calculated as only 1 patient
|
SECONDARY outcome
Timeframe: pre-dose (0 hour), 1, 1.5, 2, 4 and 6 hours post AM dose for escalation dose or pre-dose (trough) for maintained dosePopulation: PAS: all enrolled patients with at least 1 dose of study drug and at least 1 post-dose PK assessment after Protocol Amendment 4 or after re-entering the study.
Trough PK concentrations and PK profiles at steady-state were collected.
Outcome measures
| Measure |
Part l: Core Cohort
n=4 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=13 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
n=6 Participants
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
n=1 Participants
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
n=1 Participants
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
PK Parameters: Tmax ss,
|
1.50 hour (hr)
Interval 1.0 to 4.1
|
1.50 hour (hr)
Interval 1.0 to 4.0
|
1.26 hour (hr)
Interval 1.0 to 2.0
|
NA hour (hr)
NA: geo-mean/CV geo-mean could not be calculated as only 1 patient
|
NA hour (hr)
NA: geo-mean/CV geo-mean could not be calculated as only 1 patient
|
SECONDARY outcome
Timeframe: pre-dose (0 hour), 1, 1.5, 2, 4 and 6 hours post AM dose for escalation dose or pre-dose (trough) for maintained dosePopulation: PAS: all enrolled patients with at least 1 dose of study drug and at least 1 post-dose PK assessment after Protocol Amendment 4 or after re-entering the study.
Trough PK concentrations and PK profiles at steady-state were collected.
Outcome measures
| Measure |
Part l: Core Cohort
n=2 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=11 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
n=6 Participants
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
n=1 Participants
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
n=1 Participants
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
PK Parameters: T1/2 ss,
|
6.39 hour (hr)
Geometric Coefficient of Variation 13.8
|
3.54 hour (hr)
Geometric Coefficient of Variation 49.8
|
4.32 hour (hr)
Geometric Coefficient of Variation 47.8
|
NA hour (hr)
NA: geo-mean/CV geo-mean could not be calculated as only 1 patient
|
NA hour (hr)
NA: geo-mean/CV geo-mean could not be calculated as only 1 patient
|
SECONDARY outcome
Timeframe: Week 22Population: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04. This analysis was on the male patients only.
A patient was considered to be a responder if his/her mean UFC level from the three 24-hour urine samples collected at Week 22 was ≤ ULN (as defined by the local laboratories) or represented a ≥50% decrease from baseline. Participants with controlled or partially controlled UFC were defined as: Controlled UFC: mean UFC level \<= upper limit of normal (ULN). Partially controlled UFC: mean UFC level \> ULN but with \>= 50% reduction from baseline.
Outcome measures
| Measure |
Part l: Core Cohort
n=15 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=4 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Were Responders on 24-hour Urine Free Cortisol (UFC) at Week 22
Responders
|
80.0 Percentage pf participants
Interval 51.91 to 95.67
|
75.0 Percentage pf participants
Interval 19.41 to 99.37
|
—
|
—
|
—
|
|
Percentage of Participants Who Were Responders on 24-hour Urine Free Cortisol (UFC) at Week 22
Controlled UFC responders
|
80.0 Percentage pf participants
Interval 51.91 to 95.67
|
75.0 Percentage pf participants
Interval 19.41 to 99.37
|
—
|
—
|
—
|
|
Percentage of Participants Who Were Responders on 24-hour Urine Free Cortisol (UFC) at Week 22
Partially controlled UFC responders
|
0 Percentage pf participants
Interval 0.0 to 21.8
|
0 Percentage pf participants
Interval 0.0 to 60.24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approx. 7 yearsPopulation: Safety Analysis Set (SAS): All patients in the Core PoC follow-up cohort who received at least one dose of study treatment after reentering the study and all patients in the Expansion cohort who received at least one dose of study treatment after Protocol amendment 04.
Escape is defined as loss of UFC control (i.e. UFC \> ULN) on at least 2 consecutive visits at the highest tolerated dose after previously attaining UFC normalization)
Outcome measures
| Measure |
Part l: Core Cohort
n=15 Participants
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Follow-up Cohort
n=4 Participants
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study.
|
10mg Bid
Participants in the Expansion cohort who took 10mg of osilodrostat
|
20mg Bid
Participants in the Expansion cohort who took 20mg of osilodrostat
|
30mg Bid
Participants in the Expansion cohort who took 30mg of osilodrostat
|
|---|---|---|---|---|---|
|
Number of Participants With Escape
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
Adverse Events
Part l: Core Cohort
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Part ll Core: Expansion Cohort
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Part ll Core: Follow-up Cohort
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part l: Core Cohort
n=12 participants at risk
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Expansion Cohort
n=15 participants at risk
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Expansion of this study. These patients were all newly enrolled into the phase ll part of the study
|
Part ll Core: Follow-up Cohort
n=4 participants at risk
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Cardiac disorders
Tachycardia
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Endocrine disorders
Pituitary-dependent Cushing's syndrome
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Haemoglobin decreased
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Vascular disorders
Takayasu's arteritis
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
Other adverse events
| Measure |
Part l: Core Cohort
n=12 participants at risk
Participants took an ascending dose of LCI699 (osilodrostat) from 2mg bid or 5 mg bid, up to 30 mg bid and participated in Part l of this study. 4 patients in this cohort moved to Part II of the study
|
Part ll Core: Expansion Cohort
n=15 participants at risk
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Expansion of this study. These patients were all newly enrolled into the phase ll part of the study
|
Part ll Core: Follow-up Cohort
n=4 participants at risk
Participants took an ascending dose from 2mg bid or 5 mg bid, up to 30 mg bid and participated in the Part ll Core Follow-up of this study. These patients were patients who transferred from Part l Core phase of the study
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
2/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
33.3%
5/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
20.0%
3/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Metabolism and nutrition disorders
Hyposideraemia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Blood and lymphatic system disorders
Eosinophilia
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Cardiac disorders
Sinus bradycardia
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
50.0%
2/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
40.0%
6/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
50.0%
2/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Endocrine disorders
Diabetes insipidus
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Endocrine disorders
Glucocorticoid deficiency
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Endocrine disorders
Pituitary-dependent Cushing's syndrome
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Eye disorders
Blepharospasm
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Eye disorders
Visual impairment
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
2/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
2/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
75.0%
3/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
3/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
26.7%
4/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
75.0%
3/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
41.7%
5/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
53.3%
8/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
50.0%
2/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Tongue disorder
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
50.0%
2/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
3/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
50.0%
2/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
General disorders
Asthenia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
33.3%
5/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
50.0%
2/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
General disorders
Chest discomfort
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
General disorders
Chills
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
General disorders
Fatigue
|
58.3%
7/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
20.0%
3/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
75.0%
3/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
General disorders
Feeling drunk
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
General disorders
Generalised oedema
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
General disorders
Influenza like illness
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
General disorders
Malaise
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
26.7%
4/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
General disorders
Oedema peripheral
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
20.0%
3/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
General disorders
Peripheral swelling
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
General disorders
Pyrexia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Bronchitis
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Cystitis
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Fungal infection
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Furuncle
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Groin abscess
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Influenza
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Laryngitis
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
20.0%
3/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
50.0%
2/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Onychomycosis
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Skin infection
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Tongue fungal infection
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
20.0%
3/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
75.0%
3/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
50.0%
2/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
16.7%
2/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
20.0%
3/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Aldosterone urine increased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Amylase increased
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Blood aldosterone decreased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Blood corticotrophin increased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
33.3%
5/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
75.0%
3/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
26.7%
4/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Blood creatinine increased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Blood gonadotrophin abnormal
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Blood luteinising hormone decreased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Blood phosphorus
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Blood potassium decreased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Blood pressure decreased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Blood pressure increased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Blood prolactin increased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Blood testosterone free increased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Blood testosterone increased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
100.0%
4/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Blood uric acid increased
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Cortisol decreased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Cortisol free urine decreased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Cortisol free urine increased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Gastric pH decreased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Haemoglobin decreased
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Heart rate increased
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
High density lipoprotein decreased
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Hormone level abnormal
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
26.7%
4/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
75.0%
3/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Lipase increased
|
16.7%
2/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
50.0%
2/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Neutrophil count increased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
50.0%
2/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Oestradiol increased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Platelet count decreased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Protein total increased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Renin decreased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Urine leukocyte esterase
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Vitamin D decreased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Weight decreased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
Weight increased
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Investigations
White blood cell count increased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Metabolism and nutrition disorders
Folate deficiency
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
3/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
50.0%
2/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
3/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Nervous system disorders
Cold-stimulus headache
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
20.0%
3/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Nervous system disorders
Dizziness postural
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Nervous system disorders
Headache
|
25.0%
3/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
40.0%
6/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
50.0%
2/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Nervous system disorders
Hypoaesthesia
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Nervous system disorders
Hypogeusia
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Nervous system disorders
Paraesthesia
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Nervous system disorders
Presyncope
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Nervous system disorders
Somnolence
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Psychiatric disorders
Abnormal sleep-related event
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Psychiatric disorders
Disorientation
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Acanthosis nigricans
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Acne
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
20.0%
3/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
13.3%
2/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
50.0%
2/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Melanoderma
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
2/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
20.0%
3/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
6.7%
1/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Vascular disorders
Hot flush
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Vascular disorders
Hypertension
|
0.00%
0/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
20.0%
3/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
0.00%
0/15 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
25.0%
1/4 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 350.6 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER